May 2012
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way.
Contents
2. Introduction......................................................................................................3
3. Responsibilities...............................................................................................4
4. Related documents.........................................................................................7
6. Validation approach........................................................................................8
14. Glossary.........................................................................................................35
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2. Introduction
This is the most important part of a validation plan. It
summarizes what the project is all about and what you are
trying to accomplish with it and with validation. It summarizes
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3. Responsibilities
Identifies all validation responsibilities like system owner,
system manager, validation team, QA, operations, plant
maintenance/engineering, IT, lab support services, users etc.
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3.8 Consultants
Some of the activities can be out-sourced to
consultants. For example, developing specifications
based on inputs from users, developing IQ/OQ/PQ
procedures, leading vendor assessment programs and
preparing validation summary reports
3.9 Vendors
Design, develop and validates equipment, software
and systems during development following
documented procedures
Provides documented evidence that the software has
been validated
Provides documentation on the validation approach
taken by the vendor
Provides a complete list of functional and performance
specifications that can be used to derive a company's
specification for the project
Allows a vendor audit if required by regulatory
agencies or the user
Provides documentation and services for installation
qualification
Provides documentation and services for operational
qualification
Provides training on the technique and operation of
the system
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3.10 All
Assure that all people who are involved in the
specification, design, development, validation and use
of equipment and computer/networked systems are
trained and understand regulations.
4. Related documents
Corporate and/or local validation policies
Standard operating procedures
Checklists, e.g., for vendor assessment
Templates, e.g., for change control
5. Products/processes to be validated
and/or qualified
5.1 Equipment, computers, software, network modules and
networked systems that are used in regulated
environment. Requirements may come from the US FDA
and EPA, EU authorities, Japanese MHW or any other
country that may have an impact or the companies
business.
5.2 Equipment, computers and networked systems and
software that are critical to the operation of a company or
department
5.3 New equipment, computers and networked systems
5.4 Existing equipment, computers and networked systems
5.5 Any computerized system that is used to create, modify,
maintain, archive, retrieve or transmit data (US FDA 21
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6. Validation approach
Approach for new systems
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The database should also have entry fields for dates of the
last and next operational qualification.
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7.5. Documentation
On completion of equipment qualification, documentation
should be available that consists of:
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# Assessment Comment
1 Through references Useful if there is no experience with
outside your company the vendor within your company.
Criteria are
acceptance of the vendor in the
market place
image of the vendor as software
supplier
quality reputation of the product
2 Through own Experience may come from the
experience with the product under consideration or from
vendor other products. Criteria are
Quality of the products (failure
rate)
Responsiveness in case of
errors
(phone call, on-site visit, bug fix)
3 Through own Very much the same as in 2, but
experience with the more accurate because most likely
product the software has been developed
and is supported by the same
people as the new purchase
4 Checklist - Mail audit Use checklists available within your
company, through public
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9.5 Documentation
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11.6 Testing
Develop a test plan to test the Macro and Spreadsheet
application for all functions the user will use. Develop a matrix
that links functions to be tested to requirement specifications.
Develop test cases and test data sets with known inputs and
outputs. Describe the test environment and the execution of
tests. Test protocols must clearly state the Macro title, revision
number, and file name. Tests should describe the test
environment and the execution of tests. Develop test cases and
data test sets that can be used for current and future testing
that simulate as much as possible the real-life environment (life
testing). Include test cases with normal data across the
operating range, boundary testing and unusual cases (wrong
inputs). Include procedures to verify calculations. Test
procedure and results should be documented, reviewed and
approved by the programmer’s, and for complex macros by
quality assurance departments.
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At the user’s site the system with the new software revision
should undergo formal installation qualification (IQ) as for
a new system.
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14. Glossary
For an extensive glossary on qualification and validation see:
www.labcompliance.com/glossary
The glossary also includes terminology for network hardware
and software.
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Checklists
Forms
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Form ID
Date:
System ID:
Location:
Description of change
(should include
reason for change)
Expected impact on
validation
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Form ID
System Location:
Initiator:
Description of
problem, how it is
solved now and how
the new software can
improve efficiency
Expected duration of
use and frequency of
use: e.g., 6 months, 5
times a day
Comments:
Comments/Recommendations:
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QA
Consultant
IT
Lab
Validation
group
Vendor
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User
QA
IT
Validation group
System owner
Business
Management
System Owner/
Management
QA Compliance
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