Anda di halaman 1dari 36

Building a Smart

Laboratory 2012

An introduction to From the publishers of

the integrated lab


One Platform, One Goal,
One Winner

The quantity of data your laboratory produces continues to grow, and so do your data management needs.
You need a head start. By integrating LIMS, SDMS and ELN, STARLIMS consolidates all types of data, from
all types of laboratories, into a single platform. Streamline your lab with just a single web-based informatics
system to deploy and support, even across widely distributed and global organizations.

Solid, comprehensive and flexible LIMS, ELN and SDMS—


the informatics solution that powers your lab. www.starlims.com

An Abbott Company
Offices: Argentina, Australia, Belgium, Canada, China, Colombia, France, Germany, Hong Kong, Indonesia, Ireland, India, Israel, Japan, Kuwait, Malaysia,
Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Qatar, Romania, South Africa, Spain, Sweden, Thailand, Turkey, UAE, UK, USA, Venezuela.
Building a Smart Laboratory 2012 Contents/Introduction

Contents
Laboratory automation
and laboratory informatics
4
Introduction –
Industry evolution and trends 5
The smart laboratory
The LIMS market 5
The ELN market 5
There is no specific definition of a ‘smart’ laboratory. The term is often
What is laboratory automation? 6
used in different contexts to imply a laboratory that is designed in a way
An overview of laboratory informatics 8
to optimise it’s physical layout, or that incorporates the latest technology
Laboratory instrument systems 9
to control the laboratory environment, or that the laboratory is using the
Simple analytical instruments 9
latest technology to manage its scientific activities. For the purposes of
Computerised instrument systems 10
this publication, it is the latter definition that applies.
What is a LIMS? 10
The progressive incorporation of information technology into
What is an LES? 12
all aspects of laboratory operations has resulted in fundamental
What is an SDMS? 14
changes in lab work. Prior to about 1900, most scientific innovation
What is an ELN? 14
and development was either embedded in an industrial process,
or was an outcome of academic or privately initiated research. The
progressive introduction of industrial
Business requirements 16
R&D laboratories heralded a new era “The dependence
Costs/return on investment 16 of innovation and development with
Regulatory compliance and systems validation 17 an extensive dependence on the skills, of science on
GAMP software categories in a LIMS 17 knowledge and creativity of individual technology grows
GAMP software categories and 18 scientists. The evolution has continued
system life cycle for a LIMS into the ‘information age’ with a growing relentlessly”
System life cycle, detail and documented evidence 18 dependence on information technology,
Patent-related issues 18 as both an integral part of the scientific process and as a means of
The America Invents Act – implications 21 managing scientific information and knowledge.
Data integrity 22 The dependence of science on technology grows relentlessly. From
Data authenticity 22 the basic application of computational power to undertake scientific
Data management 22 calculations at unprecedented speeds, up to the current situation
Knowledge management 23 of extensive and sophisticated laboratory automation, black box
measurement devices and multiuser information management systems,
Technical issues 25 technology is causing glassware and paper notebooks to become
increasingly rare in the laboratory landscape.
Systems architecture 25 A frequently articulated fear about the relentless incorporation of
Cloud 26 technology in scientific processes is the extent to which it can de-
Pay by the cycle 26 humanise laboratory activities and reduce the demand for intellectual
Operational vs. investment budgeting 26 input, or indeed any fundamental knowledge about the science and
Data storage 26 technology processes that are in use.
Data integration 27 The objective of this publication is to present a basic guide to the
The internet and web-based tools 28 most common components of a ‘smart’ laboratory, to give some general
Semantic computing 28 background to the benefits they deliver and to provide some guidance on
Electronic records 28 how to go about building a smart laboratory.
Data formats 29
Electronic records management 29 John Trigg
Systems integration 29 phaseFour Informatics
2012
Functional/user requirements 30
Business case development 32 This guide, Building a Smart Laboratory, is written and compiled by John Trigg, director of
phaseFour Informatics, with contributions from Peter Boogaard, founder of Industrial Lab
and project management Automation, and Bob McDowall of McDowall consulting. It has been produced by Europa
Science, the publishers of Scientific Computing World, and edited by Beth Sharp.
Internal culture and 33
©2012 Europa Science Ltd. All images Shutterstock.com
technology adoption
Unit 9 Clifton Court, Cambridge, CB1 7BN, UK.
Summary, references and further reading 34 Tel: +44 (0)1223 211 170. Fax: +44 (0)1223 213 385. Web: www.scientific-computing.com

3
Laboratory automation
and laboratory informatics
The two primary areas of technology that of repeating work and enhancing the ability computing environment that embraces all
apply to a smart laboratory can be broadly to communicate and collaborate in real time. aspects of the application of technology
categorised as laboratory automation and The application of technology in today’s to lab operations and its interaction with
laboratory informatics. In general, laboratory labs is required to achieve timely progress other company systems. This has become
automation refers to the use of technology and remain competitive. Laboratories increasingly important as the deployment of
to streamline or substitute manual devoted to activities such as high-throughput an ELN generally represents the final step in
manipulation of equipment and processes, screening, combinatorial chemistry, making a lab fully electronic and hence raises
whereas laboratory informatics refers to the automated clinical and analytical testing, the demand for interconnection between all
application of information technology to the diagnostics, large-scale biorepositories,
handling of laboratory data and information. and many others, would not exist without
The field of lab automation comprises advancements in lab automation. “The term ‘laboratory
many different automated lab instruments, The term ‘laboratory informatics’ informatics’ has been
devices, software algorithms and has been progressively creeping into the progressively creeping into
methodologies used to enable, expedite and vocabulary of lab workers during the past
increase the efficiency and effectiveness of decade and has come to represent the field
the vocabulary of lab workers
scientific research. Laboratory informatics of information technology as it is applied to during the past decade”
is the specialised application of information a wide range of processes and operations.
technology aimed at optimising lab Typically, it addresses the convergent field laboratory systems. In this sense, being fully
operations. It encompasses electronic lab of laboratory data and information systems, electronic and being fully integrated are two
notebooks, sample management, data which includes laboratory information different things.
acquisition, data processing, reporting and management systems (LIMS), electronic For most labs, the reality is that fully
scientific data management. laboratory notebooks (ELNs), scientific data ‘electronic’ corresponds to an application-
Both disciplines aim to increase management systems (SDMS) and laboratory centric portfolio of ‘systems’ that were not
productivity, improve data quality, reduce execution systems (LES), as well as the tools necessarily designed to work together, and
lab process cycle times and to facilitate data used for data acquisition and data processing. for which interoperability is hampered by the
acquisition and processing techniques that There is a very good reason why the use of lack of standards and is therefore dependent
would otherwise be impossible. Furthermore, a generic term such as laboratory informatics on custom solutions. What we aspire to is an
retention and accessibility of knowledge is important; we need to get away from our ‘integrated’ laboratory that is modular, based
through online storage and search algorithms traditional application-centric approach to on standards and is designed to facilitate
aim to offer additional benefits through the laboratory computing and think in terms connectivity, data sharing and collaboration.
re-use of existing information, the avoidance of the big picture, i.e. a fully-integrated Over the past two to three years the

4
Building a Smart Laboratory 2012 Laboratory automation and laboratory informatics

informatics market has experienced two laboratory information management systems share. As a consequence, the market suffers
interesting developments: firstly, the were born. In the early 1980s, first generation from some degree of ‘hype’ (see Figure 1).
previously separate LIMS and ELN sub- commercial LIMS systems started to appear, Just where ELNs sit on the Gartner Hype
markets have started to overlap, causing a usually based on minicomputers, and offered Cycle[3] is dependent on the view you take
certain amount of confusion as a consequence some basic functionality to support sample within your organisation and your scientific
of our application-centric mind-set. And and test management, and reporting of results. domain. The general market position is
secondly, a number of merger and acquisition A second generation of commercial LIMS probably somewhere around the ‘Trough
activities have reshaped the vendor line-up, started to appear in the late 1980s, typically of Disillusionment’, although individual
specifically in the ELN field. So what do taking advantage of relational databases to vendors may occupy positions either side of
these developments mean? Do they represent provide more sophisticated functionality. The this point. The ‘Trough of Disillusionment’
something more fundamental than just development of client-server based systems can be considered to be the turning point
functional and commercial opportunism represented the next (third) generation of when we’ve got past the hype and can then
and present some tentative steps towards commercial systems, taking advantage of focus on delivering true benefit. Chemistry-
addressing the integration problem? the evolution of the personal computer. The based and generic ELNs are probably already
There is no distinct boundary between beyond this point, as indeed are the majority
laboratory automation and laboratory of LIMS products.
informatics. At one extreme, lab automation “During the past 40 years, Commercial ELNs have evolved from two
can be interpreted as a field of engineering the development of approaches: discipline-specific and generic.
and laboratory informatics as a field of Generic software provides the architecture
information management, but both contribute
increasingly powerful and tools to create and search content, and to
to a common objective of enhancing the computers has played a major work collaboratively in a way that satisfies the
efficiency of laboratory processes. role in the advancement needs of almost any science-related industry.
of laboratory data and Discipline-specific ELNs are aimed at a
particular market segment such as chemistry,
Industry evolution and trends
information management” biology or analytical. These systems
are usually tailored to work with other
During the past 40 years, the development fourth generation emerged as the internet discipline-specific software tools. Most of
of increasingly powerful computers has and wireless connectivity developed, offering the commercial ELNs offer a combination of
played a major role in the advancement of opportunities to extend the reach of LIMS generic and discipline-specific functionality.
laboratory data and information management. beyond the confines of the laboratory. The initial evolution of the ELN market
Initially, the high processing capabilities of As LIMS products were increasingly was centred on the provision of functionality
computers were exploited to perform complex adopted by labs, three specific additional to support small molecule chemistry. Most
calculations at unprecedented speeds, often requirements gradually became apparent. of the experimental processes associated
off-line on a company’s mainframe. Firstly, the need to be able to transfer data with synthetic chemistry are well established,
Gradually, as digital technologies from instruments directly to the LIMS in reasonably consistent and are well supported
progressed and with the development of the order to avoid transcription errors; secondly, by desktop software tools. Integrating these
microprocessor, computers were brought into the need to manage the instrument data functions in an ELN that addresses the
the lab and used for data acquisition and data files from which data stored in the LIMS broader capability to create, manage and
processing. As a consequence, a number of was derived; and thirdly, the need to handle store a full experimental record was a logical
laboratory techniques were revolutionised unstructured data, graphical data and collate progression.
to such an extent that it is now difficult to sample data. These requirements led to the As a consequence, chemistry-based ELNs
believe, by modern standards, just how crude development of scientific data management exhibit a good deal of maturity. If there is
certain measurements had been and also systems (SDMS) and electronic laboratory segmentation in this part of the market, it is
what degree of confidence or accuracy they notebooks (ELNs). determined to some extent by the origins and
offered. The cutting out and weighing of Functionally, the LIMS products have scope of the available products. Some, for
chromatography peaks to obtain quantitative become increasingly sophisticated through example, will be perceived as an enterprise-
data is one such example. the successive generations to the point that wide solution, others will have more of a
the dividing line between LIMS and other focus on utility and personal productivity,
informatics solutions has become less clear. whilst others will provide a generic ELN
The LIMS market capability that accepts the integration of
third-party software tools.
As computers became more prevalent in The ELN market Biology, however, has presented a bigger
the laboratory, another of their capabilities challenge to the ELN vendors. The more
started to be exploited, i.e. their ability to The ELN market has been developing rapidly diverse and complex nature of biological
manage workflow transactions. This led during the past decade, with continuing processes and outcomes creates a need
enterprising scientists to develop simple, growth, but it still exhibits some degree of to capture not just the data, but also the
custom computerised workflow systems to instability with a large number of vendors complex interrelationships between the
operate in conjunction with data acquisition (in excess of 30 purveyors of products that data. This, coupled with a diverse portfolio
and data processing. And that basically is how purport to be an ELN) competing for market of biology-specific software tools, begs the

5
Laboratory automation and laboratory informatics Building a Smart Laboratory 2012

Fig. 1: The Gartner Hype Cycles workflow requirements. Some organisations


have chosen to implement generic ELN
Visibility functionality within the framework of their
standard IT tools, such as Lotus Notes and
SharePoint. In the academic community,
blogging tools have been used to record
experimental work and thus provide the
basic features of an ELN, with a strong
emphasis on sharing and collaboration, and
in the form of a laboratory journal.

What is laboratory automation?

Laboratory automation is defined as the use


of technology to streamline or substitute
manual manipulation of equipment
Technology Peak Trough of Slope of Plateau of
trigger of inflated disillusionment enlightenment productivity and processes. In considering the smart
expectations laboratory, the first stage is to look at basic
Maturity lab processes and computerised systems:
how do they currently operate and how
Technology Trigger: The first phase of a Hype Cycle is the ‘technology trigger’ or should they integrate? A lab may have
breakthrough, product launch or other event that generates significant interest. many data systems associated with the
Peak of Inflated Expectations: In the next phase, a frenzy of publicity typically generates main analytical techniques, such as
over-enthusiasm and unrealistic expectations. There may be some successful applications of a chromatography, MS, UV, NIR, etc., and
technology, but there are typically more failures. so can appear on the surface to be very
Trough of Disillusionment: Technologies enter the ‘trough of disillusionment’ because they effective, but in practice these are islands of
fail to meet expectations and quickly become unfashionable. Consequently, the press usually automation in an ocean of paper.
abandons the topic and the technology.
The main way that data is transferred
Slope of Enlightenment: Although the press may have stopped covering the technology, from system to system is via manual input,
some businesses continue through the ‘slope of enlightenment’ and experiment to understand
using paper as the transport medium –
the benefits and practical application of the technology.
a slow and inefficient process. Furthermore,
Plateau of Productivity: A technology reaches the ‘plateau of productivity’ as the benefits of
the process will have evolved over time and
it become widely demonstrated and accepted. The technology becomes increasingly stable
and evolves in second and third generations. The final height of the plateau varies according to may have additional tasks that do not add
whether the technology is broadly applicable or benefits only a niche market. any value to the laboratory output and so it
becomes very slow and inefficient.
The diagnostic approach to an integrated
question, do biologists just need a generic procedures) or Test Methods. The products laboratory is to map the current processes
ELN that will integrate with their existing are more structured than we would expect and then redesign and optimise them to
software tools, or do they need a complete from a ‘conventional’ ELN and in some use IT systems effectively and efficiently,
suite of functionality that is embedded in respects appear to be functionally closer to ensuring they deliver business benefit in
the ELN? The dilemma for the biologists a LIMS. terms of productivity, IP protection and
is whether there is a commercial ELN This particular segment of the regulatory compliance. Therefore, the process
that addresses their specific and diverse market has seen a number of vendors maps for the current working practices
requirements. Furthermore, for those extending the functionality available in describe what you do and why you do it. In
companies that need to support chemists their LIMS to embrace some of the more many instances it will be due to one or more
and biologists, the question is whether it unstructured requirements associated with of the following:
is possible to find a single vendor solution experimentation. It could be argued that such •  Custom and practice (we have always
that addresses the requirements of both products may be better labelled as ‘laboratory worked this way);
disciplines, or whether to choose the best of execution systems’ as they follow a very •  Evolution over time (we have had new
breed for each discipline. prescriptive approach applicable to those projects or new tasks to do);
Interestingly, within the past two or communities engaged in regulatory-based •  Extensive quality control checks (the FDA
three years, there seems to be another testing. didn’t like our previous way of working.
emerging ELN domain; that of QA/QC The generic functionality required just The main aim is to understand where there
and the regulatory world. A few vendors to replace a paper notebook can be a simple are bottlenecks and issues in the process
have concentrated specifically on this area, authoring tool capable of generating a – analyse and find the root causes as they
with products that are strongly aligned to compound-document. However, additional will help you to challenge and improve
laboratory workflows, following the step-by- capability will be needed for storing and the process. When the current process is
step execution of SOPs (standard operating searching documents, and for addressing redesigned and optimised, the aim must be

6
©2012 PerkinElmer, Inc. 400256_01. All rights reserved. PerkinElmer ® is a registered trademark of PerkinElmer, Inc. All other trademarks are the property of their respective owners.

ENSEMBLE
INFORMATICS
FOR BETTER
SCIENCE
Better science happens when scientists have the best tools to work with. Ensemble® is an integrated suite of in-
dustry leading informatics solutions backed by PerkinElmer’s 75 year reputation for quality and service. From
R&D right through to QA/QC and manufacturing, scientists can depend on the Ensemble
suite to provide the informatics tools they need to make better science happen.
Ensemble. Informatics For Better Science.

www.perkinelmer.com/informatics
Laboratory automation and laboratory informatics Building a Smart Laboratory 2012

to have, as far as it practicable, electronic •  Network cabling must not have a single ‘management’ context that is handled by
ways of working and effective and efficient point of failure. Cables, switches and traditional IT tools used elsewhere in the
hand-offs and transfers between applications routers need at least two routes; enterprise. Cross discipline collaboration
and organisational units. •  Sufficient network bandwidth (capacity) tends to happen around the experiment layer.
There are three basic operating principles to handle laboratory data. Are your files Below that is an increasing specialisation of
of the smart laboratory that should be used 50kB CDS files or 1GB high-resolution data types and tools where only a few systems
to redesign or optimise the laboratory NMR files? This needs to be designed are deployed across workgroups.
processes.[1] These are: into the network; The lower three layers in the diagram
1. Capture data at the point of origin: If you •  Computer hardware, especially servers represent the broad scope of laboratory
are going to work electronically, then data and data storage devices, must be informatics, embracing laboratory
must be electronic from first principles. resilient and fault tolerant: dual power instrument systems, scientific data
However, there are a wide range of data supplies, dual network and redundant management systems (SDMS), laboratory
types that include observational data disk storage; execution systems (LES), laboratory
(e.g., odour, colour, size), instrument •  Power backup in case of breaks in information management systems (LIMS)
data (e.g., pH, LC, UV, NMR, etc.), electrical supplies, not only in the and electronic laboratory notebooks (ELN).
and computer data (e.g., manipulation computer room, but the communication Overall, there has been a trend towards
or calculation of previous data). The cupboards for switches and routers to convergence in the informatics market place.
principle of integration must be balanced prevent loss of data in transit; The consequence of convergence is somewhat
with the business reality of cost-effective •  Backup and recovery systems to ensure confusing for potential customers since the
interfacing – what are the data volumes data are not lost. term ELN is used in a very liberal sense. In
and number of samples coupled with the fact, it is inherently ambiguous since the
frequency of the instrument use? ‘electronic notebook’ is always expected to do
2. Eliminate transcription error checks: An overview of laboratory far more than the ‘paper notebook’ and the
Never re-type data, and design simple informatics additional functionality will be dependent on
electronic workflows to transfer data and the type of laboratory in which it is deployed.
information seamlessly between systems. The broad relationships that exist in Most of the confusion is related to the
This requires automatic checks to ensure laboratory computing are represented in analytical and QA market segments where
that data is transferred and manipulated Figure 2. Although the exact terminology the differences between ELNs, LIMS and
correctly. Where appropriate, implement may vary from organisation to organisation, SDMS are becoming less clear. The following
security and audit trails for data integrity generally speaking, research and/or identifies the core differences:
and only have networked systems for development programmes generate projects ELN: Experiment-centric. An authoring
effective data and information sharing. or studies. These generate experiments, tool that handles unstructured data and
3. Know where the data will go: Design data which generate measurements, which in offers generic and specific functionality
locations before implementing any part of turn generate data. The triangle represents to support different scientific disciplines.
the laboratory automation or informatics the different layers of abstraction that exist Supports IP protection, knowledge re-use,
environment. The fundamental in R&D information flows. These are almost productivity and collaboration.
information required is the volume of always handled by different systems. LES: Procedure or experiment-centric.
data generated by the instrumentation Above the experimental layer is the Basically able to handle structured data
and where the data will be stored, i.e. in
an archive system, with the individual
data systems or on a networked drive?
The corollary is that security of the data
and backup are of paramount importance
in this electronic environment. In Fig. 2: Information
addition, file-naming conventions are Structure
essential to ensuring that all data is Programmes
uniquely identified, either manually or Document
automatically. If required, any archive Management
and restore processes must be designed
and tested so that they are reliable and Projects
Project Management
robust. The key message when designing
electronic workflows is to ensure that
Experiments
once data is acquired it is not printed Laboratory Notebook
out or transcribed again, but transferred
electronically between systems using Interpreted/Processed Data
validated routines. In addition, if working SDM/LIMS
electronically there will be total reliance
Raw Data
on the IT infrastructure and support Laboratory Instrumentation
systems, which need to be robust:

8
and some unstructured data. Specifically the on-going cost of maintenance, support
designed to meet the requirements of the and the retention of knowledge that can add
GxP environment. Simplifies repeated considerably to the total cost of ownership.
operations. Supports electronic SOPs.
LIMS: Sample-centric. Primarily designed
to handle structured data and offer sample Laboratory instrument systems
and test management, batch operations
and industry-specific workflows. Secure lab The range of instruments and computerised
information hub. Supports compliance. systems used in laboratories is very wide,
SDMS: Data-centric. Handles data files extending from simple instruments such
from lab instruments, meta-data, documents as pH meters and analytical balances
and the relationships between them. to sophisticated chromatographic and
Unravelling the functional and business spectrometric systems. However, all are
requirements is an essential first step in any similar in the fact that software is used to
informatics project and it is easy to fall in to manage the operation of the instrument, in
the trap of focusing on the solution, i.e. we read-only memory (ROM) or in a separate
need a LIMS, we need an ELN, etc., when computer system to provide control of the
the focus should really be on the underlying instrument, as well as acquiring, processing,
problem. Although the convergence issue storing and reporting results.
in the ELN market creates some confusion, Regardless of the type of instrument or
it also highlights the fact that there are a system used, they form the foundation of the
number of viable alternatives to replacing a smart laboratory, as they are involved with
paper lab notebook. By fully understanding generating the analytical data used within the
the problem and identifying the functional laboratory. Information is abstracted from
needs of the laboratory, the solution may be the data by a variety of mechanisms and used
found in alternative informatics applications; to make decisions. However, without the
the challenge is to find the best overall fit for foundation layer comprising the analytical
the laboratory’s workflow. instruments and systems, the informatics
One specific aspect that generally portion will not function.
creates considerable concern during vendor
assessments is the extent of the ‘fit’ of the
vendor’s product to the list of functional Simple analytical instruments
requirements. In some cases this may lead
to a dilemma about ‘buy’ or ‘build’ and For a simple analytical instrument (e.g. a
furthermore, if the decision is ‘buy’, what to balance) the software is integral. It is capable of
do about the missing functionality. storing user-defined parameters or methods,
As the informatics market has matured, but typically there is no data storage capability
most products offer greater degrees of offered. Therefore, data is traditionally
configurability in order to avoid the need captured by either observation into a
to write code to address any custom laboratory notebook or by a printout from
requirements. This enables an organisation the instrument. However, these instruments
to purchase a commercial product and are often critical in determining the quality of
configure it in ways that meet functional the result and require a different approach to
and cosmetic requirements, without causing integration within a smart laboratory.
any incompatibility with the core code. As there is no data storage capability, the
Customisation, involving writing code, can in instruments need to be interfaced to a system
some circumstances put significant barriers with storage functions, such as a LIMS or
in the way of future product upgrades and ELN. Interfacing needs to be direct with the
create high costs for both maintenance and receiving system, however as more intelligence
further development. is being built into simple systems, some
There may be instances where an balances have touch screens that are able to act
organisation may choose to develop as terminals for LIMS and ELNs.
informatics solutions internally if it feels In other cases, vendors make data capture
that its requirements cannot be adequately systems to capture and buffer data from
addressed by commercial products. In this these instruments and add integrity features,
case, the financial implications need to be such as the identity of the analyst making
given considerable attention. Although the the measurement, data and time, sample
development cycle, using in-house, paid-for information and audit trail entries to comply
labour, may undercut purchasing costs, it is with regulatory or quality guidelines.
Laboratory automation and laboratory informatics Building a Smart Laboratory 2012

Computerised instrument Some considerations for design of a LIMS are the registration of samples
systems computerised systems: and associated data, such as provenance,
•  D
 ata generated by instruments must be customer, due dates, etc.; the assignment of
Some of the more sophisticated laboratory capable of being stored directly on secure tests to the sample; scheduling and tracking
instruments have a separate computer servers rather than local hard drives to of the sample and tests; recording the test
system running software to control the protect the records; procedure, equipment and materials used
instrument. This software is generally •  D
 atabases are preferable to flat file during testing; the review, approval and
proprietary to the instrument vendor and structures as the audit trails are more aggregation of test results for the sample; and
has the capability to acquire, store and encompassing and that trending is the preparation of customer reports.
process analytical data and to report results. possible across analytical runs; The major business benefits of a LIMS
Typically, most of these instruments are •  N
 etworked data systems are better than are typically associated with increasing
designed to operate primarily in standalone several standalone data systems of the workflow efficiencies by eliminating manual
mode, although there is increasing ability to same type. The best example of this is a data entry and transcription errors. This is
transfer data to a central server for secure networked chromatography data system achieved through interfacing lab instruments
data storage. Examples of this type of system where data can be acquired in one for two-way communication of sample IDs,
are chromatography data systems (CDS), laboratory and reviewed in an office. work lists and results, and by the integration
UV spectrometers, mass spectrometers and Most computerised systems are not designed with other lab systems such as electronic
nuclear magnetic resonance spectrometers. for fully electronic working; electronic laboratory notebooks (ELN) and scientific
There is typically a gap, however, in the signature capability may be present to enable data management systems (SDMS).
software capability and how the system work to be undertaken with an electronic A LIMS also acts as a major repository
is used in a laboratory. The software of of the records of analytical testing and can
these computerised systems has the ability be a source of historical data associated with
to process and interpret the data as well “The major business benefits the organisation’s products and production
as produce the final reportable value. In of a LIMS are typically processes. In addition, the transactional
practice, many labs do not use the software nature of a LIMS enables a secondary record
to its full capabilities and will print out the
associated with increasing system to be maintained as an audit trail
data and enter it manually into a spreadsheet workflow efficiencies by to track date, time, user and, if necessary,
for calculation, print out the calculation eliminating manual data entry what change was made within the system.
and then enter it manually into a LIMS and transcription errors” This data may then be used to satisfy quality
or ELN for reporting. Obviously this is assurance requirements in terms of data
not efficient and the process needs to be integrity and can also be used to generate a
redesigned to work electronically as outlined process, but there is little, if any, ability to wide variety of management reports of the
earlier: acquire data electronically at the hand off work electronically. As an example, lab’s performance.
point of origin and never retype or check if an analyst completes an analysis, would Where a LIMS is used in a regulated
for transcription error (see ‘Laboratory a supervisor know to review the data when environment, it is necessary that the system
automation’). they logged onto the system? In the large be validated and placed under change
The instrument data system must process majority of instrument data systems the control. See ‘Regulatory compliance and
the acquired data and then pass the reduced answer is no. This is a challenge for a really systems validation’ for more detail on
data or a final result to a LIMS or ELN for effective smart laboratory. regulatory compliance.
reporting. To ensure this is effective, some In reality, a LIMS is more complex than
procedural controls need to be in place if the just a single application, due in part to the
data system does not provide the functions. What is a LIMS? convergence issues described in ‘An overview
The primary requirement is a file-naming of laboratory informatics’. In practice, the
convention to identify files uniquely for a A laboratory information management term LIMS can refer to the LIMS application;
specific analysis or analytical run. system (LIMS) provides the basic functions analytical instruments interfaced directly
A potential downside of integrating to address sample and test management with the LIMS; lab data systems and
systems in this way is that decision-making and has become the standard tool for computer systems interfaced with the LIMS
can be divorced from the instrument. analytical and QC laboratories for registering (chromatography data systems, scientific data
For example, if a result is generated in a samples, assigning tests, gathering and management systems, electronic laboratory
pharmaceutical lab where a computerised managing results, and issuing reports. notebooks, etc.); and applications outside of
system is connected to a LIMS containing With a growing level of sophistication in the laboratory that are also interfaced to the
the product specification, the analyst knows the relevant information technologies and LIMS (enterprise resource planning systems).
the results is out of specification (OOS), but configurability, most LIMS now offer a range As an example, Figure 3 shows the full
the data needs to be transferred to the LIMS of functionalities associated with sample scope of a computerised system that could
to make the formal determination of this and test management to provide a more represent a smart analytical/QA/QC lab.
fact. It is a regulatory requirement that ‘poor’ integrated solution to support workflows and Designing the LIMS environment means
results must not be discarded, otherwise the processes customised to a range of industry- that you need to consider all the other
laboratory can be accused or testing into specific requirements. systems in the lab that must interface with
compliance or falsification. The basic functions to be found in the LIMS. This includes other applications

10
Wtah’s
miknag
yuor dtaa
so hrad to
depecihr?
Whether you’re managing it, searching through it, tracking it,
analyzing it, collaborating with it, sharing it, reporting it or protecting
it – you need simple ways to get clarity and add value to your data.
You’ll find the solution at IDBS
www.idbs.com/scw12

Enabling Science
Laboratory automation and laboratory informatics Building a Smart Laboratory 2012

such as scientific data management systems Fig. 3: Diagram of a LIMS environment


(SDMS), chromatography data system (CDS)
and electronic laboratory notebooks (ELN),
as well as various related data systems that Electronic Document Enterprise Specification
Management System Resource Planning Management
may be interfaced to any of these systems, or (ERP) System
(EDMS) System
that operate independently. It also includes
analytical instruments, chromatographs and
other sources of laboratory observations
shown in the lower half of Figure 2.
Data can be transferred to the LIMS by a Laboratory Information Management System
variety of means: (LIMS)
•  Direct data capture from an instrument
interfaced to the LIMS;
•  Data capture from an instrument with
analysis and interpretation by the attached
data system and only a result is transferred Scientific Data Electronic Lab
CDS System
to the LIMS; Management System Notebook
•  As above, but the results or electronic
records are transferred to the LIMS via a
scientific data management system;
Data Data Data
•  Laboratory observations can be written System System System
into a notebook then entered manually into
the LIMS or captured electronically via an
electronic laboratory notebook (ELN) and Laboratory
Analytical Instruments Chromatographs
transferred electronically to LIMS. Observations
A pre-requisite before implementing a LIMS,
or indeed any major computerised system, is
to map and optimise the laboratory processes
that the LIMS will automate. The lab needs but unscripted, and qualitative characteristics lab worksheets and/or standard operating
to understand the process and identify any are often most important. In QA/QC analytical procedures (SOP). Ultimately, whether it
bottlenecks and their underlying cause(s). labs the routine sample-processing paradigm appears as electronic laboratory worksheets
This is especially important when dominates. Workflows are more repeatable augmenting LIMS functionality or as a
moving from a paper-based to an electronic and data is often much more structured standalone application, the LES serves the
environment due to the fact that most lab and quantitative. Analysts, therefore, need analyst by guiding them through reproducible
processes have evolved over time rather a structured and robust platform to ensure workflows, managing the associated data and
than being specifically designed to meet that proper procedures are followed, that the helping to ensure compliance.
organisational requirements. Moreover, progression of samples through the lab is An LES will extend the usability of LIMS or
the processes are paper-based rather than tracked and that discrete measurement data is ERP/QM systems, because the user interface
electronic. Refer to reference 10 for further captured and reported reliably. is more focused toward how the scientists
information about the LIMS matrix. The Analytical services and quality control operate in the laboratory. LIMS and enterprise
aim for any LIMS implementation is for a laboratories frequently deploy systems to ERP systems are often designed by technicians,
simplified and streamlined electronic process, automate high-volume workflows and ensure business and IT specialists. Since many
rather than the automation of an inefficient compliance. In addition, many of the same laboratory operations are specialised due to
and paper-based status quo. needs and characteristics hold true for analysts the scientific nature of the operation, the user
working in core sequencing and genotyping experience is very critical to assure acceptance.
laboratories that support R&D, clinical LES are fundamentally written with the end
What is an LES? diagnostics labs, and the like. Traditionally user in mind and often operate in natural
in these laboratories LIMS have been very language, or mimic existing paper forms as
Historically, electronic laboratory notebooks successful. In recent years, however, another electronic and automated equivalents.
(ELN) have been designed to accommodate category of informatics tool has emerged and This is often referred as ‘Paper on Glass’
the unstructured data typically found is gaining significant popularity. This category in the market. In a QA/QC lab, standard
in research laboratories. Researchers of informatics products is often referred to as operating procedures are developed to ensure
should be able to record scientific data, laboratory execution systems (LES) and they the accuracy and consistency of sample data. It
make observations, describe procedures, range in functionality from the simple to the is essential that the SOP be followed exactly for
include images, drawings and diagrams quite complex. each and every analysis to eliminate the risk
and collaborate with others to find new An LES is designed to support analysts’ of the measurement process being a variable.
chemical compounds, biological structures, daily workflows in a natural language form In this way, if a test result is out of range, it is
etc., without any limitation. In a research and typically provide the analyst with a User more likely to be related to the sample and not
environment, workflows are often methodical Interface (UI) that closely resembles existing the testing procedure.

12
Laboratory automation and laboratory informatics Building a Smart Laboratory 2012

Many LES allow users to adopt their it is a laboratory content management relationship between ‘broad’ (generic) and
way of working on a natural way. Typical system. By adding workflow elements and ‘deep’ (specific) systems.
procedures include: providing facilities for the management Another way of looking at this is to
•  Worksheet-based execution: Convert and storage of other documents associated define an information structure (see Figure
existing paper-based worksheets into with laboratory operations (worksheets, 2) that identifies how different systems fit
electronic forms. SOPs, safety information, reports, into the laboratory architecture. The triangle
•  SOP-based execution: Overlay data entry PDFs, office documents, images, etc.) in represents the different layers of abstraction
points, grids or other prompts on existing practice an SDMS can evolve into a more that exist in R&D information flows. These
SOP. This supplements the SOP with real- comprehensive single informatics solution are almost always handled by different
time data collection and confirmation, for some labs. systems. Above the experimental layer is
in addition to ensuring that analysts are However, an SDMS is essentially an a management context that is handled by
following the documented procedures. ‘event-driven’ system that gathers data,
•  Define unique workflows required for which may limit some of its capabilities
routine procedures. Once the process relative to the other informatics tools, and is “In its simplest form,
has been mapped based on the desired therefore more frequently seen as a system an electronic laboratory
workflow, the analyst can then be that is complementary to a LIMS or an ELN. notebook can be considered to
walked through the test process using Nevertheless, the principle on which the
the workflow. SDMS is based is that it aggregates records
be a direct replacement for the
into a logical collection associated with a paper lab notebook”
Benefits of an integrated laboratory specific entity such as a programme, project,
execution system (LES) experiment, product, sample, etc. to provide
Eliminate manual data entry and reduce a readily accessible collection of relevant traditional IT tools used elsewhere in the
transcription errors information. Embedded in an SDMS will enterprise. Cross-discipline collaboration
also be the means to provide appropriate tends to happen around the experiment
Automated SOP enforcement
security of the records by means of access layer. Below the experiment level there is an
Automate calculations control, audit trail, authorisation and change increasing specialisation of data types and
No user training required management. tools, and only a few systems are comfortably
deployed across workgroups.
Single point of truth (master record)
From a patent perspective, the
Supporting paperless lab initiatives What is an ELN? experimental layer is crucial as it captures
what the scientist is thinking and doing, and
In its simplest form, an electronic laboratory therefore provides the evidence of conception
notebook can be considered to be a direct and reduction to practice of the ‘invention’.
What is an SDMS? replacement for the paper lab notebook. In broader Intellectual Property (IP) terms,
In this instance, it can provide the generic it is the experiment layer that constitutes
A scientific data management system functionality to support ‘broad’ scientific a record of the laboratory’s work and as
(SDMS) is, in its basic form, a system used documentation processes required for such contributes to the scientific knowledge
to manage electronic records generated by patent evidence creation, cross-discipline repository. Whilst this repository resides on
laboratory instruments. Typically, an SDMS collaboration and general record keeping. paper, the ability to access, collaborate and
will provide facilities for long-term data However, the integration capabilities that share scientific knowledge is constrained. The
preservation, accessibility and retrieval. we readily associate with information implementation of an ELN therefore offers a
It is complementary to other informatics technology raise the possibility of a tighter significant opportunity to bring about greater
systems such as LIMS and ELNs in the sense coupling of other labsystems into the efficiencies in these processes.
that it can provide a common repository for ‘electronic laboratory notebook’. In other The generic function of an electronic
experiment and sample-related data files. words, can the information that is currently laboratory notebook supports the
In this way it provides a more consistent printed from other systems, cut out and ‘experimentation’ layer and contains
approach to managing laboratory data, pasted into the paper lab notebook, be abstractions from the lower data levels. So
dispensing with assorted local repositories electronically entered or linked directly to in terms of ‘what is an electronic laboratory
and offline media, such as CDs, DVDs, the electronic laboratory notebook? notebook?’, the CENSA[3] definition –
tape, etc. For example, systems that provide ‘A system to create, store, retrieve and share
As with many other lab informatics chemical structure drawing, structure fully electronic records in ways that meet
tools, the lines between a LIMS, ELN and and sub-structure searching, compound all legal, regulatory, technical and scientific
an SDMS are at times blurred through the registration, etc. are an integral part of requirements’ – is all encompassing and
incorporation of additional features to the chemistry laboratory’s process and can therefore mean different things to
complement the core functionality. The basis therefore would be expected to become different people. For this reason, a clearly
of an SDMS is a means of collecting data files part of an electronic solution. Similarly, defined understanding of the role that the
from a wide range of laboratory instruments other scientific disciplines will have specific ELN is going to play in a given organisation
and storing them, along with metadata, in a requirements consistent with their particular is absolutely essential at the start of an
uniform way in a database. In other words, laboratory processes. Figure 4 illustrates the electronic laboratory notebook project.

14
Building a Smart Laboratory 2012 Laboratory automation and laboratory informatics

An ELN can serve the organisation in litigation without any case law, and the Fig. 4: Broad vs. Deep
three ways: firstly, it can take advantage of lack of confidence in our ability to preserve
the capabilities of IT to improve the ability electronic records over several decades. Broad Functions
to acquire, manipulate, share and store data One of the more challenging barriers to Records, Patents,
(productivity). Secondly, it can facilitate a successful electronic laboratory notebook Cross-discipline collaboration
communication and sharing in real time implementation is identifying exactly what
across multi-disciplinary and multi-site role the ELN will play. The term ‘electronic
teams (collaboration). Thirdly, it can provide laboratory notebook’ is inherently ambiguous.
a scientific knowledge repository that can be In most cases the implementation of an ELN
easily accessed to recover records of the lab’s is expected to do more than just replace the
work (content/knowledge management). paper lab notebook. The paper lab notebook

Other discipline

Other discipline
The way in which lab notebooks are used is a simple authoring tool and any electronic

Biologists
Chemists

Analysts
is largely dictated by the United States’ patent authoring tool capable of generating
system which, unlike the rest of the world, a compound document will serve as a
is based on ‘First to Invent’. The need to be replacement. For some companies this has
able to demonstrate who really was first to proved to be the case.
invent requires the laboratory notebook to The combination of Microsoft Office,
be an authentic and trustworthy record that SharePoint services and a means of
describes the concept and it’s reduction to preserving documents (e.g. in PDF – portable
practice, and is signed by the author and document format) has been shown to be an
corroborated by an impartial witness. adequate replacement for paper. But if more
The reason why the migration away from functionality than this is needed, for example
paper lab notebooks has taken so long can integrating various chemistry or biology-
most likely be attributed to two factors: the centric functions or other discipline-specific
reluctance of lawyers and patent attorneys to tools, then we are really talking about an
gamble on the legal acceptance of electronic electronic laboratory rather than an electronic
records in patent interferences and patent laboratory notebook.
Business requirements
As well as the progressive introduction of business efficiency. In order to maximise important early step in the project
information technology in laboratories, the benefits, it is important to take into and can contribute significantly to the
another significant change has been the consideration the wider laboratory and project justification.
way in which the lab is managed. Business business processes that may be impacted
principles have largely replaced traditional by the new system. It is easy to fall into
scientific principles. The outcomes of the trap of just ‘computerising’ an existing Costs/return on investment
laboratory work are expected to be achieved laboratory function, rather than looking at
with increasing efficiency, lower costs and the broader benefits that may be accrued by Any organisation considering the
in shorter time frames. The combination of re-engineering a business process. The use implementation of a new informatics or
business-oriented science, legal compliance, of tools such as Six Sigma and Lean can help automation system will want to investigate
regulatory compliance, corporate governance considerably in this instance. the return on investment or cost/benefit.
and health and safety regulations has meant It is prudent to be careful with the use This is usually extremely difficult to do since
that it is not unusual to find scientists feeling of these tools, however, depending on most of the projected benefits will be based
overwhelmed with performance targets, the nature of the lab. For example, high on a certain amount of speculation and faith.
measures and bureaucracy rather than throughput, routine, testing laboratories, However, there are some important points to
engaging in scientific debate. which basically follow SOPs (standard consider in building the cost/benefit case.
Nevertheless, the combination of operating procedures), are more receptive In the case of most lab informatics tools,
information technology and modern to process improvement, while discovery the costs associated with managing paper-
business practices are responsible for and research laboratories, which are less based processes (e.g. notebooks, worksheets,
delivering significant increases in laboratory structured and are dependent on more etc.) through their full lifecycle are not always
efficiency and productivity, yet somehow diverse and uncontrolled processes, fully visible or understood. Apart from the
there still seems to be a level of expectation are far less likely to benefit from formal material costs and the costs of the archive
that information technology could do far process re-engineering. process, there is a hidden cost – whilst
more. In addition, if the technology is not Productivity and business efficiency notebooks are in the possession of laboratory
right, there is a tendency for scientists to are usually measured in financial terms, scientists, for example. The time taken in
want to fix it, or find workarounds, and this although this may be translated into time writing by hand, cutting, pasting, transcription
can become a significant distraction from savings or, in some cases, numbers of tests, and generally manipulating paper, as well
their scientific objectives. samples, experiments, etc., in unit time. as approval and witnessing processes, all
The basic goal in deploying laboratory It is necessary to be able to quote before and contribute to this hidden cost.
informatics systems is to bring about after figures for any deployment project, It is normal in building the cost/benefit
improvements in productivity and so establishing a baseline metric is an equation to look at how much of a scientist’s

16
Building a Smart Laboratory 2012 Business requirements

time is taken up in managing the paper- Regulatory compliance and • The system must be validated;
based processes and to use this as a basis systems validation •  The system should produce human
for potential time savings with an electronic readable output;
solution. (see Figure 5). Although the start-up The FDA requirements for 21 CFR Part 11 • The system should have security/access
costs are high for an electronic solution, the compliance for most life science companies control;
incremental cost of adding new users and has been directed mainly in the area of • The system should have an audit trail;
increasing storage space is modest. development, manufacturing and clinical • The system should have version control;
Return on investment (ROI) tends to focus trials. 21CFR Part 11 outlines the criteria • The system should have data validity
on the short term – how soon can we get a under which electronic records and checks;
return on the money invested in deploying electronic signatures are considered to be •  The system should have provide an
a new system – but the true value of the trustworthy, reliable and equivalent to paper electronic signature process for all signed
system may be long term and therefore far records. Typically, research or discovery electronic records that includes:
more difficult to measure since the value will tend to be outside the direct reach of Part - Printed name of the signer;
be determined by behavioural changes. For - Date and time of signature execution;
example, there is a growing body of evidence - Meaning of signature;
being presented at conferences on electronic “Any organisation •  Establish corporate internal policies and
laboratory notebooks (ELN) by numerous considering the guidelines for regulatory compliance:
companies that have implemented such a implementation of a new - Validation policy and procedures;
solution, showing that the short-term time - Disaster recovery;
savings are significant. In addition, each of
informatics or automation - Revision and change control
these organisations lists a number of other system will want to procedures;
non-quantifiable, long-term benefits: investigate the return on - System access and security procedures;
• Scientists can spend more time in the investment or cost/benefit” - Training procedures;
laboratory; - Document control procedures;
•  It is easier to find information in a •  Develop a clear, comprehensive migration
searchable archive; 11, but the principles of Part 11 compliance strategy:
• It is easier to share information; are closely related to legal requirements and - Include records, signatures, audit trail;
• I ncreased efficiency can be achieved it therefore makes good sense to take these •  Establish retention policies based on
through the elimination of paper; into consideration for an ELN project. current predicate rule requirements.
• There is a reduced need to repeat In this way, the fundamental principles Regulatory compliance and systems
experiments (knowingly or unknowingly); of the trustworthiness, reliability and validation is more common in the GxP
• Data quality (legibility) is improved; authenticity of scientific evidence can be environment and is applied to LIMS, SDMS
•  A smooth transition when people leave the supported by a robust process that defines and LES systems.
company; the course of the regularly conducted
• Online use in meetings. business activity used to create the
evidence. Furthermore, should the ELN GAMP software categories
If you have an ROI process, get as much project be extended into development areas, in a LIMS
help as you can to find out how it works then, of course, compliance will become
and how to make it work successfully.
mandatory. The Good Automated Manufacturing Practice
Consider ‘Cost vs. Value’ and think carefully
about the hidden costs of paper. In order to meet regulatory requirements, (GAMP) guidelines is an industry-written
the following criteria typically apply: document for the validation of computerised
systems used in the pharmaceutical industry
now in its 5th version.[5] In all versions
Fig. 5: System costs of paper notebooks and ELNs there is a classification of software into
one of five categories presented in Table 1.
Further discussion and debate on the GAMP
Paper software categories as applied to laboratory
computerised systems can be found in the
paper by McDowall.[6]
Electronic A LIMS could therefore contain the
System cost

following categories of software:


•  LIMS application software which is
Cost Elements
configured (category 4);
Media •  Customisation of the product using the
Storage internal scripting language (category 5);
Management Process •  Writing custom code using a recognised
Number of users
computer language to connect the LIMS
to another application or instrument
(category 5).

17
Business requirements Building a Smart Laboratory 2012

Table 1: Software categories based on GAMP 5[5] work and adopt it as my own’) and also
by an impartial witness (‘I have read and
Category 1 Infrastructure software understood this work’).[7,8]
• Established or commercially-available layered software including operating systems, Evidence in US patent interferences is
databases, office applications, etc.
subject to the Federal Rules of Evidence.
• Infrastructure software tools including antivirus, network management tools, etc. There are a number of important hurdles
Category 2 Firmware that need to be overcome, in particular the
• Discontinued – firmware now treated as category 3, 4 or 5. Hearsay Rule (by definition, if the author
• Clash with USP <1058> over approach for Group B laboratory instruments: cannot be present, then the evidence is
validate or qualify? hearsay) and the Business Records Exception.
The Business Records Exception is an
Category 3: Non-configured products
exception to the hearsay rule that allows
• Off-the-shelf products that cannot be changed to match the business processes.
business records, such as a laboratory
• Can also include products are configurable, but only if the default configuration is used.
notebook, to be admitted as evidence if they
Category 4: Configured products can be demonstrated to be relevant, reliable
• Configured products provide standard interfaces and functions that enable configuration of and authentic. The following criteria must
the application to meet user-specific business processes. be met:
• Configuration using a vendor supplied scripting language should be handled as custom •  Records must be kept in the ordinary
components (category 5). course of business (e.g. a laboratory
Category 5: Custom applications notebook);
•  The particular record at issue must be one
• These applications are developed to meet the specific needs of the regulated company.
that is regularly kept (e.g. a laboratory
• Implicitly includes internal application macros, LIMS scripting language customisations, VBA
spreadsheet macros notebook page);
• High inherent risk with this type of software.
•  The record must be made by or from
a knowledgeable source (e.g. trained
scientists);
•  The record must be made
As a minimum, a LIMS could consist organisation’s computer validation policies contemporaneously (e.g. at the time of the
of only category 4 software, but in a GMP and procedures. Each organisation can experiment);
environment it will also contain at least one have different approaches and terminology. •  The record must be accompanied by
type of category 5 software, the scripting Therefore, the terminology used here may testimony by a custodian (e.g. company
language option for customisation. This be different to some organisations. However, records manager).
mixed environment affects the life cycle and what matters is the question of whether Any doubt about the admissibility of
will lengthen the time for implementation of you performed the work described in each electronic records was largely removed by
the system. Therefore, when at all possible, section rather than argued over the name of a this statement from the Official Gazette (10
the lab should change the business process to specific document. March 1998)[9]:
match the LIMS to reduce implementation The key message is that you can ‘Admissibility of electronic records in
time and validation cost, which was demonstrate that the system was developed interferences: Pursuant to 37 CFR 1.671,
discussed in the previous section. under control and is validated. The main electronic records are admissible as evidence
documents needed for validation of a LIMS in interferences before the Board of Patent
are presented in Table 2. Appeals and Interferences to the same extent
GAMP software categories and that electronic records are admissible under
system life cycle for a LIMS the Federal Rules of Evidence. The weight
Patent-related issues to be given any particular record necessarily
To define the risk and amount of work that must be determined on a case-by-case basis.’
we need to do when validating a LIMS, we The US patent system is based on ‘First to In terms of admissibility, paper and
need to understand the categories of software Invent’ and in order to help determine who electronic records are therefore equivalent.
present. Once this is determined, the life was first to invent, most companies engaged The judgment is made on the evidence,
cycle that is necessary to implement a LIMS in scientific research create and preserve not the medium in which it is presented.
can be defined. evidence that they can use to defend their However, it is important to understand the
patents at a future date. Traditionally, this factors that impact upon the authenticity of
evidence has been in the form of the bound electronic records and that in the adversarial
System life cycle detail and paper laboratory notebook. nature of the courtroom, the opposing
documented evidence In a patent dispute, any inventor is side will attempt to discredit the record,
assumed to have an interest in the outcome the record keeping system and the record
The life cycle and documented evidence of the case, so their testimony must be keeping process. The integrity of the system
discussed in this section is based upon corroborated. Most organisations require and the process used to create and preserve
the validation of a number of systems, but these notebooks to be signed by the author records are therefore paramount.
needs to be understood in the context of an (‘I have directed and/or performed this However, a lot of organisations still

18
Business requirements Building a Smart Laboratory 2012

Table 2: Typical documentation for a LIMS validation

Document Name Outline Function in Validation

System Risk Assessment • Documents the decision to validate the LIMS or not and the extent of validation work to be undertaken
Validation Plan • Documents the scope and boundaries of the validation effort
• Defines the life cycle tasks for the system
• Defines documentation for validation package
• Defines roles and responsibilities of parties involved
Project Plan • Outlines all tasks in the project
• Allocates responsibilities for tasks to individuals or functional units
• Several versions as progress is updated
User Requirements Specification (URS) • Defines the functions that the LIMS will undertake
• Defines the scope, boundary and interfaces of the system
• Defines the scope of tests for system evaluation and qualification
System Selection Report • Outlines the systems evaluated on paper or in-house
• Summarises experience of evaluation testing
• Outlines the criteria for selecting chosen system
Functional Risk Assessment and • Prioritising system requirements: mandatory and desirable
Traceability Matrix • Classifying requirements as either critical or non-critical
• Tracing testable requirements to specific PQ test scripts
Vendor Audit Report • Defines the quality of the software from supplier’s perspective (certificates)
• Confirms that quality procedures matches practice (audit report)
• Confirms overall quality of the system before purchase
Purchase Order • From supplier quotation, selects software and peripherals to be ordered
• Delivery note used to confirm actual delivery against purchase order
• Defines the initial configuration items of the LIMS
Configuration Specification • Defining the configuration of the system policies
• User types and access privileges
• Default entries into the audit trail defined
Software Module Specifications • Specifying a custom module and how it will integrate within the LIMS
• Coding and documenting the module to pre-defined standards
• Informal developer testing and correction of the module code
Technical Architecture (Technical • IT platform(s) defined, e.g. terminal servers, database server together with resilience features
Specification) • Operating systems and service packs
• Operating environments: production, validation, etc.
Installation Qualification (IQ) • Installation of the components of the system by the IT and the LIMS supplier after approval
• Testing of individual components
• Documentation of the work carried out
Operational Qualification (OQ) • Testing of the installed system
• Use of an approved supplier’s protocol or test scripts
• Documentation of the work carried out
LIMS Application Configuration • Configuration of the LIMS application according to the configuration specification
Data Base Population • Controlled input of methods to the LIMS
• Controlled input of raw material, intermediates and in-process control sample and finished product specifications to the LIMS
Module Testing and Integration of • Formal testing of the module against the software design specification
Custom Software • Integration testing with the LIMS application
Data Migration • Identification of the data elements and fields to migrate from an old LIMS, e.g. specifications, results, ongoing stability studies
• Planning and executing the work
• Confirming the successful data migration
User Acceptance Test (e.g. PQ) • Defines user testing on the system against the URS functions
Test Plan • Highlights features to test and those not to test
• Outlines the assumptions, exclusions and limitations of approach
PQ Test Scripts • Confirmation of software configuration
• Test script written to cover key functions defined in test plan
• Scripts used to collect evidence and observations as testing is carried out
• Documents any changes to test procedure and if test passed or failed
User Training, SOPs and System •P rocedures defined for users and system administrators including definition and validation of custom calculations, input of
Documentation specifications, account management and logical security
• Procedures written for IT related functions
• Practice must match the procedure
Service Level Agreement (SLA) • Agreement between the laboratory and IT for IT and infrastructure services for the LIMS
User Training Material • Initial material used to train super users and all users available
• Refresher or advanced training documented
• Training records updated accordingly
Validation Summary Report • Summarises the whole life cycle of the LIMS
• Discusses any deviations from validation plan and quality issues found
• Management authorisation to use the system
• Release of the system for operational use (this can be a separate release certificate in some organisations)

20
Building a Smart Laboratory 2012 Business requirements

require their scientists to keep bound due to the need to maintain the integrity used in research laboratories. However, there
laboratory notebooks. This is due to the fact of each system and the consistency of the are clauses in the Act that would suggest it
that there isn’t the case law and/or other content between them. Similarly, the use of is wise not to make such an assumption. It is
experience for most legal advisors to feel generic systems for such a task can increase likely that patent interferences and interfering
as comfortable with electronic records as discovery concerns as well as the likelihood patent actions will continue for many years
they are with paper. The issue is not one of problems occurring. Further guidance for patents and applications filed after March
of admissibility, but of the weight that the should be sought from records management 2013.[10]
record will have in court. Unfortunately, we personnel and legal advisors within the There are specific circumstances described
are unlikely to see a suitable body of case law organisation in order to determine policy. in the America Invents Act that, for example,
for a great many years. A recommended approach to help require proof of inventive activities to
The high-stakes nature of the problem, uncover and resolve legal/patent concerns is remove prior art for joint research activities,
lack of experience and long-term accessibility to work with lawyers and patent attorneys to or preserve the right to an interference
concerns have caused a number of simulate the presentation of ELN evidence in if the application contains, or contained
organisations to adopt a hybrid solution the court room and work back to the creation at any time, a claim to an invention filed
– using an ELN front-end tool to author of that evidence in the laboratory. before March 2013. Until the act becomes
records and then preserving the resulting effective, and there is clarification about
records on paper. This gives the benefits the implications of the new legislation,
of paper records (for the lawyers) whilst The America Invents Act – there is no reason to either change in-house
providing the scientists with the benefit implications procedures for keeping laboratory notebooks,
of new tools. A fully electronic system or any reasons for vendors to revise the
will require scientists to sign documents Patent reform legislation, in the form of the procedures and workflows in their ELN
electronically and for the resulting record to Leahy Smith America Invents Act 2011, will products. The more immediate concerns are:
then be preserved electronically. change the US system from First to Invent to • There is a loophole that will allow people
Using multiple systems for patent First to File in March 2013. It is very tempting to prosecute a patent under the old First
evidence creation and preservation can to view this change as an opportunity to relax to Invent rules for many years to come.
expose an organisation to increased risk some of the procedural requirements of ELNs First to File isn’t dead after March 2013;
Business requirements Building a Smart Laboratory 2012

• There are some changes that mean proof


of inventive activities will be especially
important for joint research activities. You
may also need to improve the retention
of other documentation related to Joint
Research project;
• Derivation proceedings will require proof
of inventorship.
To add further uncertainty, there’s always
a chance – or indeed probability – that things
are going to end up in the Supreme Court
to examine the constitutional implications
of a move away from First to Invent. So it
does appear that the new Act makes legally
robust, signed and witnessed records of
inventive activities (generally in the form of
lab notebooks) even more critical.
With a move to First to File, there’s the • Backing up data regularly; procedures of what is expected when work is
additional pressure of getting to the Patent • Controlling access to data via security carried out in any laboratory – the integrity
Office quickly, which means that it is mechanisms; of the data generated in the lab is paramount
necessary to start paying attention to their • Designing user interfaces that prevent the and must not be compromised. This is the
patent filing process, which has historically input of invalid data; ‘quality’ aspect of the quality management
not been under much time pressure. • Using error detection and correction system (QMS) that you work under. There
software when transmitting data. is the parallel need to provide initial and
ongoing training in this area. The training
Data integrity, authenticity should start when somebody new joins the
and management Data authenticity laboratory and should continue as part of the
individual’s ongoing training over the course
Whenever electronic records are used Data authenticity is the term used to of their career with the lab.
within the framework of legal or regulatory reinforce the integrity of electronic data To help training staff we need to know
compliance, data integrity and data by authenticating authorship by means of the basics of laboratory data integrity and the
authenticity are fundamental requirements electronic signatures and time stamping. main criteria are listed below:
of the computer systems used to create, An electronic signature is a generic term • Attributable: who acquired the data or
manipulate, store and transmit those records. used to indicate ‘an electronic sound, symbol performed an action and when?
These requirements may also apply to in- or process, attached to or logically associated • L egible: can you read the data and any
house intellectual property (IP) protection. with a record and executed or adopted by laboratory notebook entries?
It will therefore be necessary for a laboratory a person with the intent to sign the record.’ • Contemporaneous: documented at the
informatics implementation project to very Generally speaking, they are considered time of the activity;
carefully consider the specific requirements admissible in evidence to assure the integrity • Original: written printout or observation
of their organisation in this area.[11] and authenticity of electronic records. or a certified copy thereof;
A digital signature is a specific sub- • A ccurate: no errors or editing without
set of an electronic signature that uses a documented amendments;
Data integrity cryptographic technique to confirm the • Complete: all data including any repeat or
identity of the author, based on a user name reanalysis performed on the sample;
Data integrity, in a general sense, means and password and the time at which the • Consistent: all elements of the
that data cannot be created, changed or record was signed. chromatographic analysis, such as the
deleted without authorisation. Put simply, The requirements for an informatics sequence of events, follow on and are
data integrity is the assurance that data is project will be somewhat dependent on the date- or time-stamped in the expected
consistent, correct and accessible. nature of the organisation’s business and sequence;
Data integrity can be compromised in a internal requirements, but security, access • Enduring: not recorded on the back
number of ways: control and electronic signatures are factors of envelopes, cigarette packets, Post-
• Human error during data entry; that must be given appropriate consideration. It notes or the sleeves of a lab coat,
• Errors that occur when data is transmitted but in laboratory notebooks and/or
from one system to another; electronically by the chromatography data
• Software bugs or viruses; Data management system and LIMS used in the lab;
• Hardware malfunctions; • Available: for review and audit or
• Natural disasters. There are a number of ways that we can inspection over the lifetime of the record.
There are many ways to minimise these assure data integrity and authenticity. The Laboratory staff need to understand
threats to data integrity. These include: first is to develop clear written policies and these criteria and apply them in their

22
Building a Smart Laboratory 2012 Business requirements

respective analytical methods, regardless BPR (business process reengineering). knowledge management is about people, not
if working on paper, hybrid systems or TQM defines the concept of continuous about information technology.
fully electronic systems. incremental improvement (doing things Definitions, theories and strategies about
To support the human work, we should well) through a data-driven, statistical quality knowledge management abound to the point
also provide automation in the form of control approach. BPR represents a paradigm of confusion. It comes with, inevitably, its
integrated laboratory instrumentation shift (doing things better) by introducing own taxonomy and semantics to add to the
with data handling systems and laboratory high level, re-designed, integrated processes confusion. However, the basis for knowledge
information management systems (LIMS) that exploit information technology. management can be represented by three
as necessary to perform the work. In any Knowledge management extends these fundamental components:
laboratory, this integration needs to include processes by addressing the contribution that 1. Enabling technologies (typically
effective audit trails to help maintain data the organisation’s collective knowledge can information technology – but it could be
integrity and monitor changes to data. make (doing better things) by taking into pencil and paper!);
Supervisors and quality personnel must account the skills, expertise and personal 2. People (the organisation, its behaviours
monitor these audit trails to assess the quality knowledge of the workforce. It is perceived by and culture);
of data being produced – if necessary a key many as a mechanism for manufacturing and 3. Processes which bring people and
performance indicator (KPI) or measurable service operations to bring about business information together (the knowledge
metric could be produced. transformation through alignment with the processes).
benefits and demands of the ‘information age’. The principles of knowledge management
What is knowledge management? (KM) all make good sense, it’s just that an
Knowledge management Very simply, it is a term used to describe ‘industry’ seems to have grown around
the processes which bring people and the topic that sees it as a potential revenue
When it comes to purchasing and information together to address the stream. The following conclusions add some
implementing laboratory systems software, acquisition, processing, storage, use and re- perspective:
return on investment is inevitably one of the use of knowledge to develop understanding • KM solutions do not come in a shrink
key drivers. The up-front requirements to and to create value. The ultimate objective is wrap box;
justify the expenditure are usually aligned to improve the performance of the business • You cannot implement KM, it is an
to process improvement and productivity. outcome;
However, there are often secondary • KM is about people – technology can
and unquantifiable requirements about “The ultimate objective is to facilitate good KM, but that’s all. Basically,
improving knowledge management in the information technology is a big part of the
organisation by sharing and making lab
improve the performance of problem, but a small part of the solution.
information accessible across departments, the business and maximise the Longer-term benefits accrue from sharing
sites and geographies. value of its intellectual capital” and making information accessible, ensuring
‘Knowledge management’ is the term that systems are easy to use, and evolving a
being applied to the processes that address culture based on collaboration. In terms of
this gap. The term carries with it some and maximise the value of its intellectual the smart laboratory, three simple rules are:
semblance of a business fad since it comes capital. In some respects, knowledge 1. Align knowledge management initiatives
with its own language and mystique, but the management is part of a continuum that with business strategy – KM has,
reality of business dependence on knowledge starts with data management and progresses eventually, to deliver some bottom-line
means that there is a growing requirement to through information management. However, results otherwise it will have no credibility;
do something to manage the organisation’s the transition between data and information 2. Integrate knowledge management
intellectual capital. is governed by rules and context. processes into the corporate culture – if it’s
Knowledge management is a business The transition between information and not ‘the way we do things around here’, in
initiative that has become increasingly knowledge is governed by context, but also terms of behaviour and culture, it will not
familiar in recent years amongst organisations by the application of a number of human get any sustainable buy-in;
striving to compete effectively in the qualities such as insight, understanding, 3. Deliver the right information to the
information age. In some respects knowledge intuition, skill and experience. It is this right people at the right time – if the
management is a logical progression from human element that sets knowledge ‘technology enablers’ are not doing the
TQM (total quality management) and management aside from TQM and BPR; right things, the strategy will collapse.

23
POWERING
INNOVATIONS IN

CHEM
& BI
Attending Pittcon, the world’s largest annual conference and
exposition for laboratory science, gives you the power to get a
hands-on look at the newest equipment from nearly 900 exhibitors.
Participate in more than 2,000 technical presentations to hear the
latest trends from industry experts and learn about recent scientific Pittcon 2013 App Coming Soon

discoveries from world-renowned researchers.

For more information on technical sessions, exhibitors and short


courses, visit www.pittcon.org.
Scan this or go to
www.pittcon.org to save
follow us
50% on registration.
Building a Smart Laboratory 2012 Technical issues

Technical issues
Information and Communication area networks, latency becomes the of the data processing is undertaken before
Technology (ICT) democratises innovation most noticeable issue and acceptable passing the output to the database server.
and enables smaller companies, academia maintenance windows may disappear if This has the advantage of distributing the
and students to get access to computing the implementation extends over multiple total processing load over a number of
that was previously only available to large time zones. In time, the system will need to clients, rather than the server, and may also
organisations. However, adopting new accommodate growing volumes of data, both allow a certain amount of personalisation
computer and infrastructure technologies in in terms of the number of data items and the of the client software to support individual
labs only makes sense if it results in better size of individual data items. Additionally, users’ needs.
and more productive scientific operations. the number of users will generate more The downside is that system upgrades
The rapidly changing field of ICT can be disparate requirements, not the least of which can become time consuming and potentially
overwhelming. Laboratory work is becoming is the concern of how many people will get troublesome depending on the local
increasingly collaborative and complex, upset if the system goes down. configuration, although centrally-managed
leveraging multiple technologies to improve systems are now making thick client systems
scientific measurement techniques and easier to deploy, maintain and support.
scientific understanding. This exponential Systems architecture Thin clients typically access the
rise in the scale of data being generated, application and database server(s) through a
combined with the increased collaboration, Multi-user informatics systems are typically browser. No local processing power is used,
has resulted in a need to rethink how data is based on two- or three-tiered structures in so the server and network performance
stored, analysed and shared cost-effectively. which the application software and database are critical factors in providing good
The primary requirement for the may share a server, or be located on separate performance. The use of a browser eliminates
deployment of lab informatics systems servers, with the client-side software deployment and upgrade costs, but may
is that they can be integrated within the deployed on a local desktop, laptop or mobile restrict or limit user configurability.
organisation’s existing IT infrastructure. device. Traditionally, the servers are based With regard to devices, successful
The IT department will be able to advise in-house, but hosted services (cloud/SaaS) deployments have been made with small
how this can be achieved and how the are generating increasing interest, based on form-factor PCs on the laboratory bench,
proposed solution will integrate with existing potential business benefits. remote desktop, Citrix and a KVM switch
investments. There are a number of factors to From the user perspective, the client-side operating between a desk-bound processor
be taken into consideration in the broader set options fall into the following categories: unit with keyboards and screens on the desk
of requirements. thick-client and thin-client. The thick client and in the laboratory.
It will be important to take geographical is usually a substantial software installation Mobile devices, such as tablets, laptops
distribution into consideration. In wide on a local computer in which a good deal and smartphones, have been less successful

25
Technical issues Building a Smart Laboratory 2012

in fixed lab environments. However, they SaaS and cloud candidates Operational vs. investment
offer an effective solution where there is a budgeting
Prototyping which requires lots
specific need for mobility. The increased
of IT infrastructure
market penetration of smartphones and From a financial perspective, the model is
tablets in the consumer market has led to a Mobile applications attractive. Instead of spending significant
rising interest in their potential in a business Non-core applications capital and subsidising a lengthy budget
context through the deployment of dedicated and planning process, a system can now be
apps or browser-based access. In general, Intensive collaboration projects funded on an expenses budget, using a pay-
small format handheld devices offer good When scalability results in high down time as-you-go pricing model, which can mean
access to data and information, but are that you stop paying for equipment that sits
Applications requiring high pre-project
typically limited when it comes to data input. idle between experiments. The cloud will
investments
significantly increase the speed of executing
Projects not requiring strict 21CFR big data computing in research because there
compliance
Cloud will be almost no wait for approving costly
Big data projects IT budgets. There is also no need to invest in
Concurrent with this interest in mobile perpetual and expensive software licenses.
devices is the deployment of cloud-based benefits of the cloud outweigh the risks, but The cloud has the potential to be the best
infrastructures that provide hosted services. in established laboratory environments, the new development going mainstream for
This approach brings with it opportunities case is unproven. scientific researchers – access to an almost
to deploy rapidly at low cost with little or Cloud computing is a combination of unlimited amount of computer power to
no capital expenditure, but does raise some technologies and service offerings that has achieve scientific calculations and text
questions about security, data integrity and the potential to increase the speed of basic searches, combined with an almost unlimited
data ownership. research projects significantly. The effort to size of disk space for an affordable price.
Some informatics vendors already offer build such a high-performance computing
this type of service. Cloud services generally infrastructure has been significantly changed
fall into one of two categories: public from weeks to minutes and doesn’t require Data storage
clouds and private clouds. Public clouds traditional IT staffing anymore, since it is all
utilise a single code base for the service to offered as an external service. Most of the short-term benefits of deploying
multiple clients that limits customisation an informatics system are associated with
and integration, but helps keep costs down. personal and laboratory productivity;
A private cloud will typically offer a code Pay by the cycle however, the long-term benefits may accrue
base specific to an individual client and will from the accumulated content of the system’s
accommodate customisation and integration, The cloud as an infrastructure gives information/knowledge repositories. This
but will normally come at a higher researchers computational access on a may raise further IT considerations over
management cost. subscription or pay-by-demand cost time with regard to how this information
Interest and uptake of cloud solutions for structure. Instant access to computational is managed and used. This means that
informatics systems is somewhat constrained power, significant lower administration the provision of adequate data storage
by IP, legal, regulatory and security concerns. costs, no capital spending headaches and no space must be taken into account. As the
Additionally, at the time of writing, cloud dependence of availability of IT resources. volumes of data grow, there is likely to be
computing is suffering considerable hype – Software as a service (SaaS) is a software an increasing need for better search and
there is little doubt that in some markets the delivery model in which software and its visualisation technologies than are typically
associated data are hosted centrally in the available today.
SaaS vs. cloud cloud and are typically accessed using a thin In addition, consideration must be given
client computer or tablet device, or using a to the nature of the data and how it can be
Cloud: • Service level agreement
web browser over the internet. efficiently stored, retrieved and interpreted.
All • Emergency and escalation
about Zero footprint applications imply that no For these purposes, it is necessary to
plan
the data software needs to be pre-installed on your distinguish between the content of the ELN
• Back-up services
client. This significantly helps to simplify (experimental write-up) and external data
• On-demand scalability installation procedures – a browser is all you (laboratory data) to which the write-up may
• On-demand capacity need. To successfully upload large datasets, be electronically linked. Over time, they
SaaS: • Subscription (Pay as you go) it is critical to have access to fast network may present two separate data preservation
All • Free and paid services infrastructures. Limited network bandwidth, problems. Lab data is often stored in
about especially in start-up phase, may result into proprietary formats, so forward compatibility
• Application consultancy
what frustration and should be avoided. As a to future application and operating system
offerings
you can
do with • Application support researcher, you want to avoid thinking in releases will be critical. Additionally,
the data • Automatic updates computer terms. the location of these files will need to
• No investment in software
The table on page 27 summarises the be managed carefully to avoid breaking
overall nomenclature and major acronyms electronic links.
• Minimal hardware investment
for the most common service models. Electronic records management is

26
Software as a service licensing types

SaaS Software as a service: Software distribution model in


which discrete applications are hosted by a vendor
or service provider and made available to customers Would you like to improve…
over the internet.
productivity, data collection, workflow,
PaaS/STaaS Platform/Storage as a service: External service and compliance in the lab
that provides the hardware, operating system,
software upgrades, security and everything else
…without any IT headaches?
related to the day-to-day hosting of an (enterprise) LabsForm offers versatile, LabsForm also provide ready to
application. user-friendly data management use solutions for a cross-section
solutions for any laboratory of laboratory processes:
IaaS Infrastructure as a service: Provision model to whatever the size or discipline. Labnotes - Forms and
outsource equipment used to support operations, Using our modular based system templates for bioanalytical GLP
including storage, hardware, servers and networking you can build secure electronic compliant Laboratories
components. alternatives to your paper C-Tracker - An accounting tool
worksheets, lab books and to track cells or compounds as
DaaS Desktop as a service: The outsourcing of a procedures. Creating a made-to- they move through the lab
virtual desktop infrastructure to a third-party service measure system to suit your
exact requirements. DocMan - A document
provider. management system for the
Our software has proven returns circulation, reading and recording
XaaS Anything as a service: Refers to an increasing on investment. Please visit our of key documentation in the lab
number of services that are delivered over the website for further details about
internet rather than provided locally or on-site. our products and services -
www.labsform.com

therefore a key function to be considered Create more than just a paperless


from the start of a project and will require laboratory with LabsForm
the assignment of adequate resources,
from an IT perspective as well as a records
management perspective in order to
realise the long-term benefits of a growing
Changing the face of data collection www.labsform.com
knowledge repository (see ‘Electronic records
management’).

Data integration Lab Execution System (LES)


“Cloud The Paperless Lab
The introduction of an ELN to a laboratory computing is Lab Automation
raises the question of how easy is it to a combination
make data available to the ELN from other of technologies
lab systems. For example, do the data
formats need to be converted to make them
and service
accessible? How easy it is to get results, offerings
spectra, chromatograms, images, reports, that has the
etc. stored on a LIMS into the record of potential
an experiment stored in an ELN, and
how easy was it to get the results, spectra,
to increase
chromatograms, images, etc. into the LIMS the speed of
in the first place? The question of integration basic research A fully Web Based (HTML 5) Web, Cloud & Tablets.
is paramount to the future of efficient lab projects Laboratory Execution System. Eliminate and optimize the paper
workflow and therefore a Paperless
information management, not only from
the perspective of record keeping, but also
significantly” We provide a flexible workflow environment to:

Lab Automation Solution to - Reduce Documentation efforts


for productivity and real-time collaboration. - Online Data Entry (incl. instrument
The issue here is not the format of the final enable the Paperless Lab. integration) and Result processing
document, but the format of the underlying - Web Grids - online data sheets
data and this is an area where proprietary file - Schedule Lab Work efficiently
within iVentionScheduler
formats have dominated.
- Get real-time access
If we step outside the lab for a moment to information
and look at some of the developments in
other domains, one of the most striking
advances is occurring in the framework of Easy to use
collaboration and the role of the internet. Easy to implement
The use of social networking tools has
info@ivention.nl +31(0)358870511 www.ivention.nl
Technical issues Building a Smart Laboratory 2012

Fig. 6: Semantic computing sources, both of data and of functionality,


that could all be integrated to create the
applications we need. The second principle
was that of participation; of people making
Trusted SW the web applications more useful even as they
worked with them. This usually meant that
Proof they contributed their own knowledge by
sharing the data as they manipulated their way
Logic through these applications.
The semantic web promises even more

Encryption
Signature
Rules/Query
in the sense that adding metadata, i.e. more
Ontology meaning, to the data and information
on the web will enhance the capability
RDF Model and Syntax of the technology to understand content
and therefore take some of the burden of
XML Query XML Schema intelligently finding and filtering information
within a given context. If this goal is
XML Namespaces
successful, it promises further personal
URI/IRI Unicode productivity gains.

Semantic computing

Research is an extremely information-


illustrated how technology can enhance Four laws of computing – capacity and
intensive endeavour. As a rule, experimental
collaboration once some rudimentary data requirements data is both dynamic and distributed. New
standards are in place. The relative ease of data and properties of research samples and
incorporating text, audio, images and video Moore’s Law Formulated by Gordon models are continuously invented. It becomes
(1965) Moore: ‘Every 18 months
into a compound document (web page) with to two years, twice as
very difficult to track the entire experiment
links to other documents and references to many transistors can from hypothesis and methods to the raw data,
similar documents is, in principle, akin to the be fitted onto a chip of to the processed and analysed data, through
role of the ELN. Furthermore, this approach any given area for the to the results, conclusions and reports, and
does not require much more than an internet same price’ (computers then to the management decision processes to
become faster and the
browser to gain access to the document, price of a given level of
find and use the information. As data becomes
which means that the document is easily computing power halves distributed into cloud repositories, it becomes
available from anywhere with internet access every 18 months) increasingly important to use semantic
and is device-independent; i.e. any device methods to annotate and be able to relate
Metcalfe’s Attributed to Robert
that can run a browser should, within reason, these data to other scientific information.
Law (1980) Metcalfe: ‘The value of a
be able to access, display and provide editing network is proportional to Ontologies and hierarchically-organised
capability to the document. the square of the number controlled vocabularies are fundamental
of nodes’ (as a network to helping the subject matter experts find
grows, the value of being the right information (Figure 6). Cloud
connected to it grows
The internet and exponentially, while the
computing and semantic web technologies
web-based tools cost per user remains the are now becoming mainstream in leading
same or even reduces) research organisations and we have been
The continuing evolution of the internet applying these during the past decade to turn
is having a significant effect on laboratory Gilder’s Proposed by George data into shared and actionable knowledge.
Law (1990) Gilder: ‘Bandwidth grows
informatics with an increased need to deploy The impact of semantic web technology in
at least three times faster
web-based tools to support geographically than computer power’ (if the cloud is significant and will considerably
dispersed communities and mobile users. computer power doubles decrease the need for central warehouses of
Web 2.0 was the generic term used to identify every 18 months, then information. There will be far less need to
the change in the role of the internet as it communications power transfer large amount of data across networks.
doubles every six
became a collaboration space rather than
months)
just a presentation space. There were two
basic principles behind this. The first was Zuckerberg‘s Every year, for the Electronic records
that software applications would run on Law (2011) foreseeable future, the
the web itself rather than on the desktop. amount of information One of the most fundamental issues in
you share on the web will
This changed the nature of the web from double
replacing paper with electronic media is the
a collection of destination sites to a set of concern over long-term data preservation.

28
Building a Smart Laboratory 2012 Technical issues

This is an issue that every electronic records formats. In some markets, this situation is decision in the implementation project to
initiative has to face, regardless of scope or being progressively addressed by means of determine just how ELN records will be
scale. Whether it is government records, open platforms that provide data interchange managed over the long-term.
medical records, scientific records or a and systems’ integration standards. In the Basic records management guidelines are
personal collection of digital photographs, the clinical world there is good progress, driven by as follows:
problem is the same; what do we have to do the demand of health records. Unfortunately, • Integrate electronic content/records
to ensure that we can still access these records the laboratory world does not have an management;
in 50 years’ time, or more? The track record equivalent driver. • Understand the legal implications of
of the IT industry in addressing long-term For this reason, it becomes important to electronic records;
data preservation is not good; proprietary data establish not only how the laboratory records • Establish a file plan;
formats, content tied to the application, lack of are managed, but also how data files are • Establish an electronic records preservation
integration standards, unreliable media and a stored and where. Although most commercial file plan;
lack of a stable operating system environment ELNs will accommodate data files in the • Establish a records management team;
all conspire to produce a major challenge in ELN database, best practice is generally to • Train the technical team;
switching to electronic records. store data in a separate repository, possibly • Establish and communicate policies;
For laboratory informatics, there are two an SDMS, with appropriate links, and to • Avoid point solutions;
major factors to take into consideration to include appropriate graphical representation • Don’t keep electronic records forever.
guarantee the long-term preservation of of the data in the ELN; basically the electronic General requirements for electronic
records: data formats and electronic records equivalent of pasting in selected graphical records are summarised in the table below.
management. instrument output into a paper lab notebook.
In this way, the ELN contains sufficient
information to support the conclusions of Systems integration
Data formats the experiment and to allow the experiment
to be repeated, but eliminates the need to Prior to around 1900, most scientific
Currently the most common solution for manage disparate proprietary data within the innovation and development was either
electronic laboratory notebooks (ELNs) is ELN system. Where data resides outside of embedded in an industrial process or was an
to render completed experiment documents the ELN, links to this data can be made from outcome of academic or privately-initiated
as PDF or PDF/A files for long-term record within the ELN, but it will be necessary to take research. The progressive introduction
keeping. The Portable Document Format into consideration how this data and the links of industrial research and development
(PDF), created by Adobe Systems, has evolved are managed over the long term through new labs heralded a new era of innovation and
into an international standard (ISO 32000) revisions of software. development with an extensive dependence
for rendering documents in a fixed layout that on the skills, knowledge and creativity of
is device-independent. PDF/A is a standard individual scientists. The evolution has
for the long-term archiving of electronic Electronic records management continued into the ‘information age’ with
documents and is also an ISO standard (ISO a growing dependence on information
19005-1:2005). It is a subset of PDF, leaving Long-term data preservation raises the technology as both an integral part of the
out features not suited to long-term archiving. question whether the records should be scientific process and as a means of managing
The use of PDF or PDF/A is generally stored in the ELN, or whether they are scientific information and knowledge.
considered to be the best option for the transmitted to a separate records management From the basic application of
preservation of documents for IP and legal system, leaving the ELN to serve mainly as computational power to undertake scientific
purposes, but the long-term storage of lab an operational system. For large companies, calculations at unprecedented speeds,
data is a different matter. The biggest problem records management is typically a broader to the current situation of extensive and
by far is proprietary data formats. Most organisational process, managed by specialists, sophisticated laboratory automation, black
laboratory instruments are not designed with and ELNs often need to be integrated with box measurement devices and multiuser
long-term record keeping considerations an existing records management system. For information management systems, technology
in mind and generate data in proprietary smaller companies, it will be an essential is causing glassware and paper notebooks to

Quality criteria Material to be preserved Scrutiny Timescale Format

Internal Internal requirements Scientific data and Little, if any Company defined XML, De Facto
use experimental write up standards, ad hoc

Regulatory Published Primarily scientific data. Regulatory Defined by regulations XML, De Facto standards
21CFR regulations, with Some write up inspection
part 11 comment

Patents Case law, Primarily experimental write Adversarial ~ 10 years before first PDF (paper, microfilm)
Federal Rules of up. Some data come under scrutiny.
evidence, etc. Retain for 50 to100
years

29
Technical issues / Functional/user requirements Building a Smart Laboratory 2012

become increasingly rare in the lab landscape. presents a difficult ROI calculation due to for best-of-breed products, rather than single
However, the progressive introduction the growing need to transfer and share data vendor solutions.
of information technology into laboratories seamlessly between systems. Despite all of The lack of integration standards is a
has been conducted in a piecemeal fashion, the outstanding advances, it would be quite well-established problem in the laboratory
generally leading to the adoption of best-of- revealing to add up the total cost to industry world, and there’s very little evidence of a
breed solutions for specific lab requirements. to create and maintain custom solutions and universal solution emerging. Ongoing efforts
The consequence is that laboratories have a middleware to solve integration problems, in with AnIML[12] and the Pistoia Alliance[13] have
plethora of systems that were not necessarily addition to how much time has been wasted yet to gain enough inertia to make a realistic
designed to work together, that are based in not having direct and immediate access difference. SiLA (Standardization in Lab
on proprietary platforms and that adopt to data that is locked in inaccessible systems Automation)[14] is attempting to introduce new
proprietary data formats. and how many risks have been taken in using interfaces and data management standards
The deployment of an electronic laboratory all kinds of crude and insecure methods of to facilitate the integration of lab automation
notebook has been the catalyst for an transferring data. To some extent this is a systems. The IQ Consortium (International
increasing demand for systems integration. Up legacy issue as most of our current systems Consortium for Innovation and Quality
to now, integration has largely been achieved were not necessarily designed to work together. in Pharmaceutical Development) is an
by bolting together various disparate systems In addition, systems often do a poor job of international association of pharmaceutical
that meet specific functional requirements separating the content from the functionality, and biotechnology companies aiming to
and which often end up as a group of thus making the integration challenge even advance innovation and quality in the
interconnected silos. Although this has been more difficult. development of pharmaceutical products
an important stepping-stone that has often The demand for integration has been a through scientifically-driven best practices
delivered significant productivity benefits, technology driver behind a number of merger and standards.[15] Furthermore, the Institute
it comes at the cost of significant effort and and acquisition activities in the informatics for Laboratory Automation[16] is proposing
with the worrying legacy of the on-going market during the past couple of years. This a collaborative programme of activity to
management of a custom solution. may well lead to progress, although it will be drive the development and adoption of data
This extensive adoption of technology tempered by the fact that scientists usually opt interchange standards.

Functional/user requirements
Gathering user or functional terms of its functionality and • Technical performance/ specified or designed by a
requirements is one of the key how it should perform in the response times; team or committee and the
tasks, usually assigned to the customer’s environment. • Technical support. team/committee members
project team, for providing The requirements may include, All of these requirements are tend to be volunteers who are
a specification against which but are not limited to: normally collated into a request committed to the concept of
potential solutions can be • General business for proposal (RFP) that will be the system, enthused about
evaluated. The task involves requirements; submitted to potential vendors. the improvements it can bring
uncovering and understanding • User/functional requirements; The RFP should also provide and can envision the potential.
user needs, distinguishing them • IT requirements; more general information, Unfortunately, the committee
from ‘wants’ and ‘nice to haves’, • Interface requirements; including an introductory process can create complex
and aggregating the needs into a • Regulatory issues; description of the organisation systems, reflect compromises
requirements specification. • Data management and the major objectives of the
In this context, reference requirements; project and diagrams showing
to ‘users’ includes not just end • Error handling; relevant workflows. It may “Gathering user
users of the proposed system, but • Reporting requirements; be preceded by a request for or functional
anyone who will interact with the • Performance requirements. information (RFI), a means of
system, or be involved with inputs The criteria that define gathering information about a
requirements is
or outputs to the system. In order required performance may potential vendor’s products and one of the key tasks
to do this, various methods may include: services, which may be used to for providing a
be used to gather needs and to • Access control and security; fine tune a final list of vendors to specification against
prioritise them. • Look and feel; whom the RFP may be submitted.
In principle, the requirements • Robustness; Unfortunately, users are
which potential
specification should define what • Scalability; notoriously bad at telling what solutions can be
the solution must do both in • Ease of use; they need. Most systems are evaluated”
30
“The demand for integration has been a
technology driver behind a number of merger Fill the Knowledge Gap
and acquisition activities in the informatics
market during the past couple of years”

It seems that one of the unfortunate


consequences of the lack of industry standards
is that there is the risk that too many disparate
efforts to solve the problem may leave us with
ACD/Spectrus
too many standards. However, another way
in which we may find the integration issues to
be solved is through the evolution of generic
technology standards. Advances in consumer
information technologies have a strong focus
on communication, sharing and collaboration
– three criteria that are essential to integration
in laboratories. In the consumer world, the
internet is the platform and the World Wide
Web Consortium manages the standards
that facilitate satisfying these criteria. The
progressive adoption of web technologies
for laboratory informatics may well enhance
the possibilities of achieving greater levels
of integration.
H3C CH3

CH3
+ O O
CH3

O O

Accelerate Future Projec ts


with Integrated Analytical and
and it is often the case that most business requirements are fully Chemical Knowledge Management
problems come from people who clarified; this ensures that the
don’t volunteer for the committee. scope of the project is defined • Extract chemical meaning from NMR, MS,
By definition, the members and can therefore help exclude HPLC, LC/MS, GC/MS, UV/IR, Raman, and more,
of the team are more committed some of the more exotic ‘needs’ in a single, multi-vendor environment
to the success of the project that might arise. Any single item
than those who are not directly on the requirements list should • Retain the human interpretation of spectral
involved. In their deliberations, justify itself not only financially, and chromatographic experiments
project teams often develop a but also in terms of its usefulness
concept of a solution which is and ease of use. • Store, search, re-analyze, and re-use live
much more sophisticated than Anecdotal experience analytical data for collaborative science
might be needed or indeed is suggests that some requirements’
economically justifiable. specifications could be shrunk
Typically the ‘requirements by between 25 and 50 per cent
gathering’ phase involves by the removal of ‘wish list’ Learn more
harvesting needs, wants and items, bringing cost savings and w w w. a c d l a b s . c o m / s p e c t r a l k n o w l e d g e
ideas from the potential user a lower cost of ownership, as
community and then engaging well as easier user adoption. It’s
in a prioritisation exercise to important for the project team
reduce the list to a specific set of and sponsors to be able to define
requirements that form the basis what business problem the ELN
of a request for proposal (RPF) will solve and to ensure that user
that can then be presented to requirements are kept simple and
vendors. It is important that the focused on solving the problem.
Business case development and project management Building a Smart Laboratory 2012

Business case development


and project management
Building a good business case requires Current laboratory processes and systems: • Identify the role (scope and scale) of
a thorough and systematic approach to • Which laboratory systems are already in existing laboratory systems in the model
understanding current limitations and future use? (Are there SOPs?) and diagrams;
requirements for the business. It is important • Which data acquisition systems are already • Test the model and diagrams against each of
to see laboratory informatics as a component in use? the lab areas and other interested parties (IT,
in a lab ecosystem (technology, processes and • Which teamwork/collaboration systems are legal, QA, records management).
people), rather than ‘just another laboratory already in use? Put together a high-level plan showing
application’. The following points should all be • Which document management systems are the relationships, processes and data flows
considered in formulating the case for a new already in use? that describe a future state for the laboratory.
informatics system: • Who is responsible for the management This should include an identified role for
• Why do we need a new system? and support of these systems? each of the lab systems and should clarify the
• What is the problem that needs to be • Is there a (electronic) records management specific functions of each. Any problems with
solved? policy? terminology should be resolved and the plan
• Is there any quantitative data that illustrates • Are there any specific policies and restraints should be tested by presentation and discussion
the problem? relating to the introduction of IT systems? with the interested parties.
• Which laboratory areas will be involved in Establish how the laboratory is currently
the project? working, paying specific attention to the use Business plan development:
• Who makes the go/no-go decision? and effectiveness of manual systems such as • Quantify the benefits of the proposal, in
• What are the issues relating to IP (internal/ worksheets, paper lab notebooks and data particular productivity gains, ROI and
legal/patent)? knowledge management, and support these
• Are there any regulatory compliance estimates with case studies;
requirements? “It is important to know • Undertake a risk assessment, paying
Clarify why the organisation thinks it what business level attention to process, technology and people-
needs a new system. This is best achieved by constraints may apply in related risks. Align the risk assessment to the
developing a problem statement that quantifies set of user requirements;
a specific problem, or set of problems, about
terms of internal, legal or • Prepare, and include in the business case,
the laboratory’s productivity and or knowledge regulatory compliance” a high-level implementation plan that
management performance. The scope and addresses any specific requirements and/or
scale of the problem (and hence, the solution) management. Also identify major electronic risks that have been identified.
should be identified. The key decision makers/ systems used for the acquisition, processing Quantitative benefits should be identified,
budget holders should also be identified, and management of data, and ask what along with all risks. An implementation plan
plus any other interested party who may happens to this data, where is it stored and for should address known risks and/or potential
have influence over a go/no-go decision. It how long? Is it communicated or transferred problems, in particular the strategic approach
is important to know what business level elsewhere – if so, how? Is it backed up and/or to roll out, e.g. a progressive deployment,
constraints may apply in terms of internal, archived? Can it be found? the composition of the project team, change
legal or regulatory compliance. Furthermore, consider if laboratory data management and user support.
is the responsibility of the lab, or does IT
Laboratory/company background: have any involvement, and what level of Human factors:
• Use organisation charts to clarify roles involvement does IT have in the purchase and • What practical problems do laboratory
and responsibilities and organisational implementation of laboratory systems? workers experience with existing lab
relationships; processes and data workflows?
• Identify the nature and scientific disciplines Future laboratory processes and systems: • How well will laboratory workers
of the laboratory work and how they relate • Based on interviews with laboratory accommodate change?
to each other; managers and staff, formulate a model that • Are there any cultural, political or other
• Are outsourced agencies (contract labs) illustrates the major relationships between internal relationships that could have an
involved? lab data and information; impact on the project?
Establish the way in which the laboratory is • Construct data workflow and laboratory Identify potential problems associated
organised, the nature of the work it undertakes process diagrams; with change management. This may be at an
and how it relates to internal and external • Identify any conflicts in nomenclature and individual level (early adopters vs. laggards) or
organisations with whom it collaborates. establish an agreed taxonomy; at an organisational level: R&D vs. legal, etc.

32
Building a Smart Laboratory 2012 Internal culture and technology adoption

Internal culture and


technology adoption
The introduction of multi-user IT systems Fig. 8: Technology Acceptance Model
into organisations has a mixed track record.
Multi-user systems are usually specified by a The degree to which a person believes that using
project team and often contain a number of a particular system would enhance his or her job
performance
compromises and assumptions about the way
Individual user’s positive or negative feelings about
people work. High level business objectives performing the target behaviour
can therefore be put in jeopardy if users do not Perceived
successfully adopt the new system. However, usefulness
most case studies on electronic laboratory External Attitude Behavioural
notebook (ELN) implementations indicate a variables toward intention
positive user take-up. This may be attributed Perceived
to the growing understanding of aspects of ease-of-use
technology adoption, originally reported by A measure of the strength of one’s intention to
perform a specific behaviour
Everett Rogers in his book The Diffusion of
The degree to which a person believes that using a
Innovations[17] and developed further by Geoffrey particular system would be free from effort
Moore in Crossing the Chasm.18]
Moore’s chasm (see Figure 7) is the gap
between the early adopters and the mainstream
market. The early adopters are a relatively easy success. Key to this is the recognition that people adoption by engaging users throughout the
market. Targeting them initially is important, but are more likely to comply with a request when: process tends to brand the implementation as a
the next phase of the marketing strategy must • A reason is provided; ‘laboratory’ project, rather than an ‘IT’ project
target the conservative and pragmatic majority. • There is give and take; and this can often make it easier for scientists to
The early adopters can play a central role in this. • They see others complying; accept the proposed change.
Since the ELN project team is likely to be formed • The request comes from someone they The Technology Acceptance Model[19] (see
from the early adopters, it can play a pivotal role respect or like; Figure 8) is an information systems theory
not only in specifying and selecting a solution, • The request comes from a legitimate source of that models how users come to accept and use
but in articulating the rationale for the ELN, authority. a technology. It suggests that when users are
provide training and ongoing support to the Concerns about user adoption can be presented with a software package, a number of
conservative and pragmatic majority. reduced by carefully choosing the project team factors influence their decisions about how and
User adoption is often considered one to ensure that these criteria are addressed, rather when they will use it. The main ones are:
of the most critical success factors of an IT than just announcing a new system and the Perceived usefulness (PU): ‘The degree
project and paying appropriate attention to user training course schedule. Typically, putting a to which a person believes that using a
requirements will enhance the likelihood of strong emphasis on user requirements and user particular system would enhance his or her job
performance’.
Perceived ease-of-use (EOU): ‘The degree to
Fig. 7: Crossing the Chasm which a person believes that using a particular
system would be free from effort’.
Pragmatists Conservatives
Looking for
The technology acceptance model assumes
Believe in
an improvement tradition that when someone forms an intention to act,
Visionaries
Looking for a they will be free to act without limitation. In the
breakthrough real world there will be many constraints, such as
Sceptics
Not
limited ability, time constraints, environmental
Technology Enthusiasts looking or organisational limits, or unconscious habits
Looking for some which will limit the freedom to act.
The Chasm

neat technology
Concentration on the positive aspects of
‘usefulness’, both to the organisation and to
the individual, and ‘ease of use’ will help users
develop a positive attitude. It is in this area that
Innovators Early Early Majority Late Majority Laggards the early adopters can have a powerful influence
Adopters of their conservative and pragmatic peers.

33
Summary, references and further reading Building a Smart Laboratory 2012

Summary
The concept of a smart laboratory will vary attrition; new laboratory workers joining the technologies, developing the right laboratory
from organisation to organisation depending on organisation will have grown up in a digital processes and creating the right culture. Keeping
the nature of its business and the technological world (digital natives). To some extent this is these three criteria in balance is fundamental to
choices it makes. Discovery and development true, but technology continues to evolve at an success. Perhaps the most critical issue is that
are increasingly recognised as two steps in a ever-increasing rate and today’s digital natives of culture. Unfortunately this cannot be created
holistic product life-cycle process rather than may find themselves challenged to keep up with or forced. As much as management may expect
standalone functions. further advances in technology, in the same way or demand their workforce develop a successful
Innovation itself has moved on from ‘Eureka today’s digital immigrants are. workplace culture, all that can be done is to
moments’ and chance discoveries to become It’s not just a basic competency in technology create the right environment that will allow the
a managed industrial process with an in-built skills that is needed, but also a deeper culture to evolve. This can take a long time and,
need to address quality, regulatory, health and understanding of the continually evolving unfortunately, can be destroyed in minutes.
safety, and IP requirements. Just doing the strategic and tactical roles that technologies The focus of the guide has been on
science isn’t enough anymore. play in the laboratory, both in terms of the technology, in the form of laboratory
With this increasing demand for science and the processes. Understanding how informatics, with due consideration to the
competency in science, technology and process to use technology is only part of the answer; lab processes to which it can be applied. We
understanding, an area of concern is how understanding why and ensuring that the right have touched on some aspects of culture
well adapted we as laboratory workers are to technologies are applied to the right processes is and technology adoption, but it must be
fulfilling industry’s needs. The view is often another matter. remembered that almost every systems project
taken that the demographic problems associated Building a smart laboratory is dependent defines user acceptance as a critical success
with ‘technology literacy’ will be resolved by on three major criteria: deploying the right factor. Technology on its own cannot do it.

References and further reading


References 13. The Pistoia Alliance: www.pistoiaalliance.org 2302 S. Edwin C. Moses Blvd, Dayton, OH 45408.
14. SiLA Consortium for Standardisation in Lab Available at www.bookfactory.com
1. Scott Jenkins, Pittsburgh Conference presentation Automation: www.sila.coop Mahaffey, R. R., (1990) LIMS: Applied Information
on Paperless Laboratory, 2004 15. International Consortium for Innovation and Technology for the Laboratory, Van Nostrand Reinhold
2. CENSA: The Collaborative Electronic Notebook Quality in Pharmaceutical Development: Nakagawa, A. S., (1994) LIMS: Implementation and
Systems Association http://iqconsortium.com/index.htm Management, Royal Society of Chemistry
3. Atrium Research: www.atriumresearch.com 16. Institute for Laboratory Automation: Sellen, A. J., and Harper, R. H. R., (2003) The Myth of
4. The Gartner Hype Cycles: www.gartner.com www.institutelabauto.org the Paperless Office, The MIT Press
5. Good Automated Manufacturing Practice 17. Rogers, E. M., Diffusion of Innovations, The Free Franklin, C., (2003) Why Innovation Fails, Spiro Press
Guidelines version 5, International Society for Press. New York Kanare, H. M., (1985) Writing the Laboratory
Pharmaceutical Engineering, Tampa FL, 2008 18. Crossing The Chasm, G.A. Moore, Capstone Notebook, An American Chemical Society Publication
6. McDowall, R.D., Spectroscopy Focus on Quality, Publishing
July 2009, p23 19. Bagozzi, R. P., Davis, F. D., & Warshaw, P. R. (1992)
7.  Using Electronic Records in Patent Proceedings, Development and test of a theory of technological
article by Damien McCotter and Peter Wilcox. learning and usage. Human Relations, 45 (7), Industrial Lab Automation:
Originally published in Managing Intellectual 660-686. www.industriallabautomation.com
Property’s World IP Contacts Handbook, 14th The Institute for Laboratory Automation:
edition, 2007. Available at www.mondaq.com www.institutelabauto.org
8. IP Expert Advice: Tips on creating a lab notebook The Integrated Lab:
that contains ‘convincing evidence’, www.edn.com/ Further reading and websites www.theintegratedlab.com
article/CA6445886.html?industryid=47048 The latest information, news and articles on LIMS:
9. Admissibility of Electronic in Interferences, Bruce Stafford, J. E. H., (1995) Advanced LIMS Technology: www.LIMSfinder.com
H. Stoner Jr., Chief Administrative Patent Judge, Case studies and business opportunities, Springer, The independent, non-commercial LIMS user’s
www.uspto.gov/web/offices/com/sol/og/con/files/ Christensen, C. M., The Innovator’s Dilemma, Harvard group:
cons119.htm Business School Press www.LIMSforum.com
10. Private communication: Colin Sandercock (Perkins Segalstad, S. H., (2008) International IT Regulations The online encyclopaedia for Laboratory, Scientific
Coie LLP) September 2011 and Compliance: Quality Standards in the and Health Informatics:
11. The ABCs of Electronic Signatures, David Pharmaceutical and Regulated Industries, Wiley- www.LIMSwiki.org
Nettleton, Lab Manager Magazine, 9 September Blackwell, Free online training courses on LIMS:
2010: www.labmanager.com/articles_ McDowall, R. D., (1987) Laboratory Information www.LIMSuniversity.com
pf.asp?ID=707 Management Systems, Sigma Press Scientific Computing World:
12. The AnIML Programme: http://animl.sourceforge.net Laboratory Notebook Guidelines: BookFactory, LLC, www.scientific-computing.com

34
Technical
Information
Bulletin
Thermo Scientific
CONNECTS™ for the Paperless Lab

CONNECTS for the Paperless Lab


delivers the methodology, technology
CONNECTS for the and services necessary to transform
Paperless Lab is a today’s laboratories into tightly inte-
combined method- grated paperless environments, while
ology, technology leveraging existing investments in soft-
and services offering ware systems, databases and laboratory
that transforms lab- instrumentation from a wide variety of
oratories into tightly commercial vendors.
integrated paperless
environments. By bridging the islands of data gener-
ated in the lab and transforming that
• Get real-time access data into information that can be used
to information across the enterprise, organizations will
• Improve regulatory reap the benefits of improved access
compliance and data to real-time information, regulatory
integrity compliance, data integrity, as well as analysis, enabling faster decision mak- facilitate data and information sharing
time and cost savings by automating ing and improving productivity. across the organization, without having
• Automate processes processes and reducing manual data to rely on access to the original appli-
and reduce manual Building on a history of informatics
handling. cation. CONNECTS technology acts
data handling innovations, CONNECTS provides ac-
CONNECTS for the Paperless Lab is as a ‘translator’ of all the individual
cess to all instrument data via a single
comprised of three unique components languages of the lab’s disparate instru-
interface and allows real-time analysis
— methodology, technology and ser- ments and is able to deliver and accept
and investigation of results. The tech-
vices — that combined deliver seamless data in the format appropriate for each
nology converts raw data to a vendor
and continuous data flows from the lab instrument.
independent XML storage format to
into the enterprise, improving results ensure future proof data archiving and
20%
REDUCTION
Thermo Scientific CONNECTS™ for the Paperless Lab:
Methodology: a comprehensive solutions-oriented consultation delivers
an assessment of an organization’s current level of laboratory automation, Did you know? By automating the
instrument integration and workflow. The assessment highlights potential laboratory companies save a tremen-
ROI, operational gains and a plan for implementing solutions that address dous amount of time and resources
instances where current workflow relies on human intervention, which can on manual activities in the lab. By
be the cause of bottlenecks or introduce errors. automating the lab, CONNECTS for
Technology: the vendor neutral suite of data integration, visualization and the Paperless Lab delivers improved
management technologies delivers comprehensive laboratory workflow efficiency, productivity, consistency,
automation, integrating instruments and equipment and connecting data quality and reduced costs typically
sources with data destinations. The technology enables consolidation of by over 20%.
analytical results, including access to raw data and instruments from web
browsers and mobile devices. For more information about CONNECTS
Services: pre- and post-implementation consulting services are optimized for the Paperless Lab,
to deliver current and future paperless environments, enabling real-time email us at
decision making based on access to aggregated information from the en- marketing.informatics@thermofisher.com
tire organization. CONNECTS Services are based on proven methodology or visit
for delivering successful projects using industry best practices. www.thermoscientific.com/paperlesslab

© 2012 Thermo Fisher Scientific Inc. All rights reserved. All other trademarks and copyrights are the property of their respective owners.

Part of Thermo Fisher Scientific


www.labware.com
www.labware.com
www.labware.com
www.labware.com
www.labware.com
www.labware.com

SELECTING
SELECTING
SELECTING
SELECTING
SELECTING
SELECTING
AN
AN
AN
AN
AN
AN
ELN?
ELN?
ELN?
ELN?
ELN?
ELN?
Be
Be
Be
Be
sure
sure
Be
sure
Be
sure
sure
to
sure
to
to
choose
to
choose
choose
to
to
choose
choose
choose
the
the
the
the
right
the
right
the
right
right
right
partner
right
partner
partner
partner
partner
partner
Implementing
Implementing
Implementing
Implementing
Implementing
Implementing
aaaseamlessly
a
seamlessly
seamlessly
aseamlessly
aseamlessly
seamlessly integrated
integrated
integrated
integrated
integrated
integrated
end
end
end
end
to
end
to
end
to
end
to
end
end
toto
end
laboratory
end
laboratory
end
laboratory
laboratory
laboratory
laboratory
informatics
informatics
informatics
informatics
informatics
informatics
solution
solution
solution
solution
solution
solution
can
can
can
cantruly
can
truly
can
truly
truly
transform
truly
transform
truly
transform
transform
transform
transform
your
your
your
your
business,
your
business,
your
business,
business,
business,
business,
and
and
and
and
and
and
leading
leading
leading
leading
leading
leading
such
such
such
such
such
asuch
aproject
aproject
aproject
a
project
aproject
project
isisa
isa
isbig
ais
big
ais
big
a
big
responsibility.
aresponsibility.
big
responsibility.
big
responsibility.
responsibility.
responsibility.

LabWare’s
LabWare’s
LabWare’s
LabWare’s
LabWare’s
LabWare’s
experience
experience
experience
experience
experience
experience
atatat
developing
at
developing
developing
at
developing
atdeveloping
developing
and
and
and
and
delivering
and
delivering
and
delivering
delivering
delivering
delivering
enterprise-
enterprise-
enterprise-
enterprise-
enterprise-
enterprise-
wide
wide
wide
wide
wide
LIMS
wide
LIMS
LIMS
LIMS
LIMS
and
LIMS
and
and
and
ELN
and
ELN
and
ELN
ELN
solutions
ELN
solutions
ELN
solutions
solutions
solutions
solutions
isisis
unsurpassed
unsurpassed
isunsurpassed
is
unsurpassed
isunsurpassed
unsurpassed
making
making
making
making
making
making
us
usus
aus
agreat
a
us
great
us
agreat
agreat
agreat
great
partner,
partner,
partner,
partner,
partner,
partner,
whatever
whatever
whatever
whatever
whatever
whatever
the
the
the
the
scale
scale
the
scale
the
scale
scale
of
scale
ofof
your
of
your
your
of
your
ofproject.
your
project.
your
project.
project.
project.
project.

For
For
Forover
For
over
For
over
For
over
20
over
20
over
20
years
20
years
years
20
years
20years
LabWare
years
LabWare
LabWare
LabWare
LabWare
LabWare
has
has
has
has
been
been
has
been
has
been
been
leading
been
leading
leading
leading
leading
leading
the
the
the
the
way
way
the
way
the
way
inway
inway
laboratory
inlaboratory
inlaboratory
in
laboratory
inlaboratory
laboratory
informatics
informatics
informatics
informatics
informatics
informatics
through
through
through
through
through
through
continuous
continuous
continuous
continuous
continuous
continuous
innovation
innovation
innovation
innovation
innovation
innovation
and
and
and
and
powerful
and
powerful
and
powerful
powerful
powerful
powerful
results.
results.
results.
results.
results.
results.
Contact
Contact
Contact
Contact
Contact
Contact
ususus
tous
toto
discuss
us
discuss
to
us
discuss
to
discuss
todiscuss
discuss
how
how
how
how
we
how
we
how
we
can
we
can
we
can
we
can
help
help
can
help
can
help
make
help
make
help
make
make
make
your
make
your
your
your
next
your
next
your
next
next
project
next
project
next
project
project
project
project
aasuccess.
asuccess.
asuccess.
success.
aasuccess.
success.

Offices
Offices
Offices
Offices
Offices
Offices
worldwide
worldwide
worldwide
worldwide
worldwide
worldwide
supporting
supporting
supporting
supporting
supporting
supporting
customers
customers
customers
customers
customers
customers
ininmore
inmore
inmore
in
more
inmore
than
more
than
than
than
90
than
90
than
90
countries
90
countries
countries
90
countries
90countries
countries

Anda mungkin juga menyukai