LARRY D.

FORTNEY
12661 James Circle
Broomfield, Colorado 80020
Phone: (303) 884-3123
Fax: (303) 469-7782
larry.fortney@summitregserv.com

U M M A R Y

35+ years system regulatory compliance experience within the pharmaceutical, biotech and
medical device industries, Quality Assurance and Computer System Validation (CSV) / Software
Quality Assurance (SQA) experience, and Project Management experience including senior
project manager positions involving CSV/SQA projects with teams of up to 30 people.

In depth knowledge of computerized life-science development and business processes

involving various types of systems (e.g. LIMS, CDS, CAPA).

Experience in 21 CFR Part 11 (Electronic Records and Electronic Signatures) remediation

planning and implementation across all aspects of the business operations.

Experience performing vendor and internal compliance audits for regulatory inspection
preparedness.

Experience in developing and implementing Computer System Validation policies and

procedures, including training materials and life-cycle management processes.

Knowledge of cGxPs for Pharmaceutical, Biologics, Medical Device, and Quality Systems: 21
CFR Parts 210, 211, & 820.

Knowledge of Good Automated Manufacturing Practices 5 (GAMP5).

Experience with global business systems including laboratory, clinical, CAPA, change control,
electronic document management, and electronic records/signatures.

Experience performing QC analytical methods and procedures for the characterization and
testing of pharmaceutical and bulk-intermediate raw materials and finished products.

Granted Level 1 security access after a National Agency Check with Inquiries (NACI) was
performed in 2008.

L AR RY F O R T N E Y

R O F E S S I O N A L

X P E R I E N C E

Summit Regulatory Services, Inc.

(October 2007 to Current)

Broomfield, Colorado
PRESIDENT

(Formerly Laboratory Support International, Inc., circa 1998)

Summit Regulatory Services, Inc. (Summit) is committed to providing the highest quality consulting services
in support of the installation and validation of custom and commercial business and quality assurance
systems to the FDA regulated pharmaceutical, biotechnology, and medical device industries.
Summits objective is reflected in our motto, Partnering to ensure quality regulatory compliance. Our
philosophy is to partner with our clients in order to provide them with the highest quality consulting
services while meeting their requirements, from project inception through completion and beyond. A
partial list of services provided by Summit follows.

Develop documentation that will eventually be reviewed by FDA or other regulating body.

Provide assistance for the purchase, implementation and validation of quality assurance
and/or business systems that fall within the FDA purview.

Provide training on a variety of subjects pertaining to the industry and its regulations and how
to comply (GxP, Part 11, etc.).

Provide quality assurance services by performing gap assessments, quality audits, review of
company and/or vendor documentation and/or processes.

Provide project management services, for small to large scale projects, for the implementation
and/or validation of systems governed by FDA regulations.

Contract Specific while with SRS:

GlaxoSmithKline U.S. (Lincoln, NE, USA)
02/16 to present
Contracted directly as a Quality Engineer (with CSV expertise) to provide input to the joint
venture integration activities, including decommissioning, based on the Novarits & GSK
Technical Service Agreement (TSA) and Master Validation Plan.
Provided Quality Management reviews and guidance for GxP and non-GxP systems for the
manufacturing, laboratory, and business areas, including:

ProFicient InfinityQS

Siemens Building Management System

FactoryTalk (Batch, AssetCentre and Transaction Manager)

Systech Vision System

L AR RY F O R T N E Y

Informance

Empower 3

ContainerWise

Systech Vision System

POMS OS2 Labeler System

Liquid Manufacturing Area Clean-in-Place Control System

TEKLYNX Central CFR Printing System

Markem Printing System

Automated Material Handling System

Other responsibilities included review and approval of change controls within TrackWise, and
approvals of changes within the Blue Mountain Asset Management application.
GlaxoSmithKline U.S. (Humacao, PR, USA)
07/15 to 12/15
Contracted directly as a Computerized System Validation and e-Compliance expert to provide
development of decommissioning and system retirement deliverables (System Retirement
Plan and Final Report) for manufacturing GxP computerized systems that are included in the
companys Decommissioning Plan and Master Validation Plan.
Novartis Business Services U.S. (Broomfield, CO, USA)
02/15 to 05/15
Contracted through Patel Consulting as an Information Governance and Management (IGM)
Manager for the new Novartis Business Services division to assist in non-GxP and GxP
projects by guiding, reviewing and approving SDLC validation documentation for computerrelated systems based on internal local and global procedures, as well as ensuring
compliance with FDA regulations, including 21 CFR Part 11.
Novartis Consumer Health, Inc. (Lincoln, NE, USA)
09/14 to 12/14
Contracted directly as a Project Quality Manager (PQM) for the Global Information Services
(GIS) department to author and/or review and approve SDLC documentation for GxP
computer-related systems based on internal local and global procedures. Deeply involved
with project teams for guidance of projects for compliance with FDA regulations regarding
computer system validation, 21 CFR Part 11, and internal quality standards.
Also worked with the Global QA & Compliance department as a QA/e-Compliance consultant
to review and approve validation life cycle documentation as needed.
Novartis Consumer Health, Inc. (Lincoln, NE, USA)
03/14 to 08/14
Contracted directly as a QA/e-Compliance consultant to perform reviews and approval of
SDLC documentation for all GxP computer-related systems based on internal local and global
procedures. Deeply involved with project teams for guidance of projects for compliance with
FDA regulations regarding computer system validation, 21 CFR Part 11, and internal quality
standards.

L AR RY F O R T N E Y

Sandoz, Inc. (Broomfield, CO, USA)

11/13 to 02/14
Subcontracted through TriCore Solutions as a QA/e-Compliance consultant where I was
responsible for review and approval of validation documentation for Manufacturing, IT, and
Laboratory computer-related systems based on Sandoz and Novartis procedures and
guidance. Also, I attended project meetings to help guide decisions for QA and e-Compliance
issues.
Zimmer, Inc. (Warsaw, IN, USA)
10/13 to 10/13
Subcontracted through Parexel and IT&E as a member of a six-person audit team, where I
was responsible for performing a Computer System Validation Quality System Inspection
Technique (QSIT) Level II based audit for this medical device company.
Novartis Consumer Health, Inc. (Lincoln, NE, USA)
02/13 to 08/13
Subcontracted through Validant to perform: 1) computer system validation for new and
remediated laboratory systems, 2) perform periodic reviews on computerized systems to
determine validated status, and 3) perform in a Quality Management (QM) role while
reviewing validation documentation, executed and non-executed, for computerized laboratory
and manufacturing systems.
Wrote validation deliverables, based on system categorization and risk, such as Validation
Plans, User Requirement and Functional Specifications, Installation Qualifications,
Operational Qualifications, Performance Qualifications, Traceability Matrices, and Validation
Summary Reports. Also, helped mentor laboratory personnel in Computer System Validation
(CSV). Also, assisted in development of Standard Operating Procedures (SOP) for labs
based on current CSV SOPs.
Laboratory systems validated during this project include:

Thermo Scientific iCE 3000 Series Atomic Absorption Spectrometer with SOLAAR and
SOLAARsecurity software.

Periodic reviews performed include:

TOM & TAM (Tool for Operational Management, and Tool for Access Management), both
Lotus Notes Databases used as part of the change control process.

QM reviews include:

FactoryTalk Transaction Manager (FTTM) and SQL Server Reporting Services (SSRS) for a
Compressed Air Flow Control System for a manufacturing line.
FTTM and SSRS for Roll Compactors in a manufacturing suite.

Measurement Control Corporation (MCC) Advanced Instrument Monitor (AIM) Tablet Press
Monitor Software Upgrade

Vendor on-site executed qualification deliverables from Leap Technologies, Inc. for the OPTDISS and OD Lite UV Fiber-Optic Spectrometer systems against 21 CFR Part 11 requirements.

Validation Documentation Remediation based on findings of the Periodic Reviews:

L AR RY F O R T N E Y

Ensur Document Management System, by Mystic Management Systems. Responsible for

reviewing, revising if necessary, or creating new validation documentation to address gaps found
during the Periodic Review process. For this system, responsible for addressing the following
documents: Validation Plan, User Requirements Specification, Functional Risk Assessment,
Electronic Records Electronic Signatures Risk Assessment, Traceability Matrix, IQ, OQ and PQ,
and Validation Report.

Merck & Co., Inc. (Boulder, CO, USA)

01/12 to 12/12
Subcontracted through Global Quality Alliance, LLC to perform computer system validation
based on the Merck SLC model, primarily in the Quality Control and Technical Services
laboratories. Validation documentation typically included: Quality Assurance Plan (QAP),
combined User Requirements Specification and Functional Requirements Specification
(URS/FRS), combined Installation and Operational Qualifications (IQ/OQ), and Quality
Assurance Summary Report (QASR) with embedded Requirements Traceability Matrix.
Thus far, the following systems have been, or are in the process of being validated as part of
this project:

BioRad GS-800 Densitometers (2)

MicroDynamics Plate Reader

Waters Acquity UPLC with LAC/E.

In addition, as part of the Quality Management System initiative, I assisted in providing a list of
GxP equipment (those equipment requiring periodic calibration and/or preventive
maintenance) for input into SAP.
As part of an efficiency initiative for the laboratories, I was asked to provide the equivalent of
the Merck System Development Lifecycle documentation for laboratory validation into two
individual validation deliverables. The eventual goal is to include only the necessary portions
of documentation required for laboratory systems, create SOPs around the use of these
templates, and incorporate this process into the change control system.
Also provided validation deliverable support to the Oss, Holland site for the Analytical
Development organization based on existing development life cycle procedures.
American Red Cross (Washington, DC, USA)
01/11 to 12/11
Subcontracted through Business & Decision North America, Inc. to perform the following:

QA support and oversight of interface, Validation & Verification, configuration verification, and
data migration testing activities, including QA reviews of project deliverables and providing QA
guidance. Performed reviews of executed test scripts and observations within Hewlett-Packard
(HP) Quality Center.
Ad-hoc support to other project work streams as deemed necessary by project management.
All QA tasks were in support of ARC's implementation of MAK-System ePROGESA software
system.

L AR RY F O R T N E Y

Navajo Manufacturing Company (Denver, CO, USA)

01/11 to 02/11
Subcontracted through FDA Compliance Group, LLC to perform the following:

Provide consultation regarding the development of the companys validation deliverables for a
Stability LIMS implementation/validation project and other GxP computerized systems, in general.
Provide documentation review and comments against Current Good Manufacturing Practices, 21
CFR Part 11 and generally accepted industry practices.

Merck & Co., Inc. (Boulder, CO, USA)

02/10 to 12/11
Subcontracted through Global Quality Alliance, LLC for full-time work during 2010, and parttime work during 2011. Hired to perform computer system validation on the following systems:

4 Waters Alliance HPLC systems

1 Waters Acquity UPLC system (including LAC/E)

3 Waters 600 series HPLCs with Waters 2487 Dual Wavelength Absorbance Detectors

3 Waters 2695 HPLCs with Waters 2487 or 2489 Dual Wavelength Absorbance Detectors

6 Waters LAC/E (Laboratory Acquisition and Control Environment) 32 data acquisition servers

1 PE Lambda 45 UV-Vis Spectrometer (UV WinLab v2.85)

1 Waters Acquity UPLC connected to a Micromass Q-TOF Ultima API TOF Mass
Spectrometer (LC/MS)
1 Sievers Total Organic Carbon (TOC) system

Validation typically included the following deliverables: Quality Assurance Plan (QAP),
combined User Requirements Specification and Functional Requirements Specification
(URS/FRS), combined Installation and Operational Qualifications (IQ/OQ), and Quality
Assurance Summary Report (QASR) with embedded Requirements Traceability Matrix.
Performed Quality Assurance review of study reports and supporting documentation for
eventual FDA submission support.
Part-time support was provided during 2011.
Dendreon Corporation (Seattle, WA, USA)
10/09 to 02/10
Subcontracted through Regulatory Compliance Partners, LLC to perform computer system
validation on several laboratory systems, including Waters Empower 2, Beckman Coulter AcT
5diff Cap Piercing Hematology Analyzer, BioMerieux BacT/Alert (and 3D) Microbial Detection
Systems, and BioTek ELx808 Absorbance Microplate Readers with BioTek's KC4 and Lonza's
WinKQCL software.
Provided validation/QA review of executed protocols for an in-house developed system
(Intellivenge) used for scheduling delivery of product, and for a performance enhancement to
the in-house developed ERP system.
U.S. Department of Agriculture Food Safety and Inspection Service (Athens, GA, USA)
10/08 to 10/09

L AR RY F O R T N E Y

Subcontracted through Foxhole Technology and General Dynamics Information Technology

(GDIT) to perform development, implementation, validation, and consulting services for a
installed LabWare Laboratory Information Management System (LIMS) for three laboratory
sites located in Athens, GA, St. Louis, MO, and Alameda, CA.
A National Agency Check with Inquiries (NACI) was performed and I was subsequently
granted Level 1 access.
Phase 1 of the project was to inspect the current validation documentation for the LabWare
LIMS and to implement changes to 1) streamline the management of the documentation, 2)
perform a gap assessment of the documentation for compliance to validation plan and
requirements, 3) ensure conformance to ISO17025 and 21 CFR Part 11 Electronic Records
and Electronic Signatures in order to meet ISO accreditation, 4) revalidate the system
covering any compliance gaps, existing functionality not originally tested and/or documented.
Phase 2 of the project was to include new development and interfacing for the integration of
several external systems functionality as part of their Laboratory Data Consolidation Project
(LDCP). Developed the Validation Plan and assisted in the development of the User &
Functional Requirements Specification for this phase. Additional funding for the remainder of
this project phase was eliminated for the short-term.
Fisher Clinical Services, Inc. (Allentown, PA, USA)
10/07 to 08/08
Provide validation documentation and execution deliverables for Phase 1 enhancements to a
custom Enterprise Clinical Trial Materials Management System (Clinical Distribution System
(CDS), Global Project Management (GPM) and Production Automated Scanning System
(PASS)). Scope of the project included Fisher Clinical Services operations facilities located in
the USA, UK, and Switzerland. Directly responsible for development of the Validation Plan for
the system, test script development for the Document Attachment Logic (DAL) module, test
script development for shared functionality, and development of the RTM and Summary
Report.
Provide validation documentation and execution deliverables for the CAPA system (Sparta
Systems, Inc. TrackWise 7.0). Scope of this project covered ThermoFisher Scientific
BioPharma Services operations facilities in the USA, UK, and Switzerland, as well as Fisher
BioServices, Clintrak, Acculogix, and Priority Solutions. Directly responsible for development
of all validation life cycle deliverables, listed below ().
Assisted in the performance of a quality audit of a new 118K square-foot warehouse facility
which will handle returns and distribution, and documented the findings in a report to Quality
Assurance.

() Project Validation Plans, Business Requirements Specification, Technical Specifications,

Configuration Specifications, Requirements Traceability Matrices, Installation Qualifications,
Operational Qualifications, Performance Qualifications, Test Summary Reports, and
Validation Summary Reports.

L AR RY F O R T N E Y

Laboratory Support International, Inc.

(January 1998 to October 2007)

Broomfield, Colorado
PRESIDENT

Direct the operations of a company dedicated to providing the highest quality documentation,
user training, and consulting services in support of the installation and validation of custom
and commercial Laboratory Information Management Systems (LIMS) and other laboratory
computer-related systems.
Contract Specific while with LSI:
PR Pharmaceuticals, Inc. (Fort Collins, CO, USA)
05/06 to 01/07
Provided consultation regarding the development of the companys validation deliverables for
an in-house developed MS Access database application used to enter, view, store, maintain
and report information pertaining to specific aspects of PRP business operations (i.e.,
documentation, QC test results, raw materials, manufacturing process, quality records).
Provided documentation review and comments against Current Good Manufacturing
Practices, 21 CFR Part 11 and generally accepted industry practices.
Nastech Pharmaceuticals, Inc. (Bothell, WA, USA)
06/06 to 12/06
Provide consultation regarding the development of the companys validation deliverables for a
Stability LIMS implementation/validation project.
Provide documentation review and
comments against Current Good Manufacturing Practices, 21 CFR Part 11 and generally
accepted industry practices.

CimQuest, Inc. (July 1998 to October 2007)

Exton, Pennsylvania
(J A N . 20 07 O C T . 20 07 ) P R I N C I PAL / D I R E C T O R , R E G I O N A L O P E R AT I O N S

Responsible for management oversight of multiple concurrent projects including scheduling,

staffing and training/development of personnel resources to achieve a superior level of quality
and customer satisfaction. Primarily responsible for business development in all states west
of the Mississippi River.

(D E C . 19 99 D E C . 20 06 ) L A B O R ATO R Y /L I MS S U B J E C T M ATT E R E X P E R T
(J U L . 1 99 8 D E C . 1 99 9 ) S E N I O R V A L I D AT I O N C O N S U LTAN T

Contract Specific while with CimQuest:

Analytical Bio-Chemistry Laboratories, Inc. (Columbia, MO, USA)
08/07 to 08/07

L AR RY F O R T N E Y

Assist in LIMS vendor selection process based on a requirements summary document.

Develop a checklist and metrics for performance versus expectations of each vendor.
Queried CimQuest clients and/or other industry contacts regarding the LIMS they use, how
long it has been in use, and how satisfied they are with the system in relation to their needs.
Summarized the findings and issued a report.
General Electric Company (Waukesha, WI, USA)
05/07 to 06/07
Subcontracted by EduQuest to perform regulatory compliance audits of a medical device
company at two separate facilities, Abbott Laboratories in Irving, TX, and Abbott Point of Care
in Kanata, Canada. Developed and distributed daily, weekly, and final audit reports.
Dendreon Corporation (Seattle, WA, USA)
03/07 to 03/07
Provided assistance for the development and execution of validation documentation for an
internally developed training management system. Responsible for development and
execution of the IOQ and the development of the IOQ Final Report.
Provided validation and Quality Assurance support as directed by the client (e.g. document
reviews).
McKesson Packaging (Concord, NC, USA)
03/07 to 03/07
Performed a GMP and Part 11 Compliance Assessment of the stability test lab, which
consisted of several HPLCs, GCs, Dissolution systems and various other laboratory systems,
and associated processes. The assessment took into consideration any issues regarding
anticipated near future expansion of the lab. Provided a high-level prioritized Improvement
Plan outlining priorities and recommendations for approach and implementation of
improvements.
Merck & Company (West Point, PA, USA)
08/05 to 12/06
Project Manager (CimQuest personnel only) for validation of 29 laboratory systems at the
West Point and Hoddesdon, England, facilities. Responsible for the successful completion of
the project, utilizing Merck and CimQuest resources to validate the following:

3 Applied Biosystems LC/MS (API 150, API 3000) [WP]

1 Perkin-Elmer Diamond DSC [HE]

1 FOSS NIR 5000 system II [HE]

3 Agilent UV-Vis 8453 (2 stand alone and 1 w/Distek online dissolution) [HE]

2 Leak Detectors (1 PTI 325, 1 ATC IGLS model E) [WP]

1 Wyatt Technology DynaPro Plate Reader [HE]

1 MS Excel spreadsheet (pipette calibration) [WP]

7 VTI Corporation, Inc. Symmetrical Gravimetric Analyzers (SGA-100) [WP]

2 Lighthouse Instruments, Inc. Headspace Gas Analyzers (FMS-1400, FMS-1400H)

[WP]

1 Micromass LCT [HE]

L AR RY F O R T N E Y

10

1 Thermoquest LCQ [HE]

1 Metrohm Titrator [HE]

1 Differential Scanning Calorimeter [WP]

1 Nikon Microscope [HE]

2 Biacore Plate Readers [WP]

1 MS Excel spreadsheet (Biacore data computation and reporting) [WP]

Project included the development of validation templates based on the Merck SLC process.
Validation document deliverables included the following: Quality Assurance Plan,
Requirements Specification, Installation/Operational Qualification, User Acceptance Test,
Standard Operating Procedures, Requirements Traceability Matrix, Quality Assurance
Summary Report, Decommissioning Plan (as needed), execution of the IOQ, and UAT, and
development of Memos to File as determined necessary by Merck.
Developed and executed the validation deliverables for the two leak detector systems, the
seven SGA systems, the two Lighthouse systems, the two Biacore systems and the MS Excel
spreadsheet listed above. In addition, executed the validation protocols and developed the
RTM and Summary Report for the DSC, and the two Biacore plate readers.
Responsible for providing the retrospective validation documentation for an Envirotrac
Computerized Environmental Monitoring System upgrade at the West Point facility. Client
requirements included a written Test Plan, combined Installation/Operational Qualification and
Validation Summary.
Centocor, Inc. (Raritan, NJ, USA)
06/05 to 07/05
Responsible for the validation of a Beckman-Coulter Vi-Cell XR Cell Viability Analyzer System
(SW vs. 2.03) and Bio-Rad GS-800 Densitometer (Quantity One vs. 4.4, PDQuest vs. 7.1)
based on Centocor validation methodology. Left the project prior to completion due to
reassignment to Merck & Co. Transitioned this project to another CimQuest consultant.
Protein Design Labs, Inc. (Brooklyn Park, MN, USA)
05/04 to 04/05
Project Manager hired to direct the prospective computer system validation of all new
computerized laboratory systems for a new facility. Team initially consisted of seven Senior
Validation Consultants. Tasks also included production of the following deliverables, and
execution of the protocols, for designated systems: System Validation Quality Assurance
Validation Plan, System Requirements Specification, System Design & Configuration
Description, System Requirements Design Test Matrix, System Validation Test Plan,
Installation Qualification Protocol, Operational/Performance Qualification Protocol,
Qualification Protocol Final Report, and System Validation Report. Responsible for the
development and execution of validation life cycle documents for the following instruments:

Molecular Devices SpectraMax Gemini EM Fluorometer using SoftMax Pro 4.7.1

Chemunex ChemScan RDI (automated bioburden) using ChemScan software version 3.3.0.

L AR RY F O R T N E Y

11

Amgen, Inc. (Longmont, CO, USA)

01/01 to 04/04
Global CimQuest Project Manager and Validation/Part 11 Consultant for Amgen's 21 CFR Part
11 compliance project. Responsible for approximately thirty CimQuest consultants working
either remotely or at facilities in Puerto Rico, California, Washington, and Colorado. Primary
responsibilities included:

Global project management support for a team of thirty CimQuest consultants across four
client sites in support of 21 CFR Part 11 gap analysis activities and remediation.

Remote vendor/software assessments for compliance to 21 CFR Part 11 and assisted in the
development of validation life cycle document templates.

Participated in the development of a global alignment process for Quality Laboratories

assessment/remediation/validation of laboratory instruments for 21 CFR Part 11.

As part of the Part 11 remediation process, developed full validation life cycle documentation
for laboratory and clinical systems (see list below) per client standards including Validation Plans,
Requirement and Design Specifications, IQ, OQ and PQ protocols, Requirements Traceability
Matrices, Decommissioning Plans and Validation Summary Reports.

BioRad Fluor-S MultiImager, Quantity One 4.4

MIDI, Inc. Microbial Identification System using Agilent GC, Sherlock 4.0

Bayer Rapidlab 860 Blood Gas Analyzer and Rapidlink Data Management Software (included
validation of a dedicated IS server)

Hoffman-La Roche (Nutley, NJ, USA)

07/00 to 01/01
Project Manager/Quality Assurance Agent responsible for reviewing and approving System
Life Cycle Documentation in support of computer system projects. Assisted in the creation of
the Computer System Validation Program including SOPs and validation templates governing
the creation of validation system life cycle documentation.
Provided Quality Assurance expertise in the development of a GAMP-3 systems life cycle
methodology for validation documentation for laboratory, clinical and business systems,
development of SDLC document templates, and provided guidance to Roche personnel and
other consultants in the development of validation documentation.
Assisted in the QA review and approval of Enterprise Resource Planning (ERP) system, which
was SAP, generated validation documents.
Centre Analytical Labs, Inc. (State College, PA, USA)
05/00 to 06/00
Re-assigned in the middle of the Roche project in order to fill in for another consultant while
away on emergency. Assisted in the development of test protocol documentation for
laboratory equipment.
Hoffman-La Roche (Nutley, NJ, USA)
03/00 to 05/00
Project 1:
Brought in to troubleshoot and manage this project (Phase 1) because it was behind schedule
and the client was dissatisfied. Regained the clients confidence and completed the project

L AR RY F O R T N E Y

12

with a high level of client satisfaction. Project extension (Phase 2 and Project 2) was the
result of turnaround in client confidence.
Phase 1 Project Manager of a seven-person team, assisted in the development of the
Computer Systems Validation Policy, GAP Analysis form, summary documents, and
exclusion justifications. Responsible for project scheduling, manpower loading, and cost
estimates for filling in the gaps found in the GAP analysis (Phase 2).
Project 2:
Project Manager to assist in verification of laboratory spreadsheets and databases. Managed
four consultants for this project.
NanoSystems, Inc. (King of Prussia, PA, USA)
03/00 to 03/00
Provided guidance for the selection process of potential LIMS vendors, defined the
acceptance criteria, assisted in the due diligence process to determine which LIMS
applications met the clients business needs and recommended an eventual LIMS purchase.
Centre Analytical Labs, Inc. (State College, PA, USA)
11/99 to 03/00
Provided systems regulatory compliance assistance focusing on the generation of a Computer
Systems Validation program. Assisted with development of a computerized systems
inventory, GAP analysis, Site Validation Master Plan, Information Systems Standard Operating
Procedures, and CSV procedures. Assisted with the implementation of a formal CSV Change
Control process.
Protein Design Labs, Inc. (Fremont, CA, USA)
10/99 to 11/99
Assisted in the development of the Installation, Operational and Performance Qualification
Protocols for the LabWare Laboratory Information Management System (LIMS).
Merck, Sharp & Dohme (Frosst Iberica, S.A.) (Alcala de Henares, Spain)
05/99 to 10/99
Provided technical direction to Merck personnel and was responsible for the development of
cost estimates, Y2K test plans, project schedules, software assessment, testing, and assisting
in the remediation of all laboratory systems for Year 2000 compliance.
Merck & Company (Whitehouse Station, NJ, USA)
01/99 to 05/99
Performed Year 2000 remote audits on clients critical suppliers and provided executive
summaries of their readiness for the Year 2000.
Ortho-McNeil (Raritan, NJ, USA)
11/98 to 01/99
Provided validation consultation for Year 2000 assessment project.
Provided technical
direction to Ortho-McNeil personnel, and was responsible for the development of cost
estimates, Y2K test plans, project schedules, weekly summaries and internal audit reports.
Year 2000 project involved the assessment, testing, and remediation assistance of equipment,
computer hardware, and software systems in the manufacturing, operations, QA/QC
laboratories, research and environmental departments.

L AR RY F O R T N E Y

13

Brought back onto this project in order to troubleshoot due to being behind schedule.
Regained the clients confidence and completed the projects on time and under budget.
Merck, Sharp & Dohme, Ballydine (Kilsheelan, Ireland)
09/98 to 11/98
Provided technical direction to Merck personnel and was responsible for the development of
cost estimates, Y2K test plans, project schedules, software assessment, testing, and assisting
in the remediation of Quality Operations, Technical Operations, and Environmental laboratory
systems for Year 2000 compliance.
Ortho-McNeil (Raritan, NJ, USA)
07/98 to 09/98
Provided validation consultation for Year 2000 assessment project.
Year 2000 project
involved the assessment, testing, and remediation assistance of equipment, computer
hardware, and software systems in the manufacturing, operations, QA/QC laboratories,
research and environmental departments.
General experience while with CimQuest:

Ensured all services were completed and all supporting documentation generated to
substantiate compliance with CimQuest policies and regulatory requirements. Monitored projects
and reported to CimQuest and client management in accordance with CimQuest project controls.

Provided technical and business guidance to senior management and Sales & Marketing and
actively participated in new business development activities including strategic business planning,
marketing/sales planning, sales presentations, and proposals.

Provided input to proposals and assisted the VPO in assessing staffing needs for project
support. Responsible for leading project teams and ensuring that projects were completed within
budget, schedule and in conformance within applicable quality, technical and regulatory
requirements.

Developed Quality & Project Plans delineating scope of Systems Regulatory Compliance
Services, applicable quality programs and SOPs, roles, responsibilities and deliverables.

Assisted the VPO in the development of project schedules, budget and manpower loading
including monitoring of progress, conducting periodic project/client review meetings. Coordinated
schedule/priorities and development of recovery plans as necessary. Reported to CimQuest and
client management in accordance with CimQuest project controls.

Assured that all systems regulatory compliance activities were performed in accordance with
CimQuest Quality & Project Plans, Quality System Manual and implemented SOPs.

Responsible for the project management of consultants responsible for all regulatory
compliance activities at client sites. Provided operational supervision and technical direction to
Senior Validation Engineers/Specialists, Validation Engineers/Specialists, Technical Writers and
Project/Documentation Coordinators. Ensured that all computer-related validation services were
completed with all supporting documentation generated to substantiate compliance with
CimQuest Validation or Project Services in accordance with the CimQuest Policy, SOPs and
Regulatory Requirements. Developed project schedules, budgets and manpower loading,
including monitoring of project progress, completion of key milestones/deliverables, development
of recovery plans as necessary and reported to CimQuest and client management in accordance
with CimQuest Project Controls.

L AR RY F O R T N E Y

14

Geneva Pharmaceuticals Inc. (June 1995 to July 1998)

Broomfield, Colorado
(O C T . 19 97 J U L . 1 99 8 ) S E N I O R A P P L I C AT I O N S S P E C I A L I S T
(J U N . 1 99 5 O C T . 1 99 7 ) A P P L I C AT I O N S P E C I A L I S T I II

Responsible for the recommendation, justification, development, implementation,

management and consulting for QA/QC computer-related automation and new technologies
including Laboratory Information Management Systems, Complaint Management System, and
other various technical QA/QC and business systems.
Acted as the liaison between the QA/QC departments for automation projects. Duties
included project management, system validation (IQ, OQ, PQ), development of user training,
and support. Developed technical and validation documentation to support adherence to
Current Good Manufacturing Practices, company and FDA requirements.

Syntex Agribusiness, Inc. NCD (April 1981 to May 1995)

Springfield, Missouri
(S E P . 19 91 M AY 1 99 5 ) L I MS M A N A G E R
(M AY 1 99 1 S E P 1 99 1 ) A N A L YT I C A L C H E M I S T
(A P R . 19 81 M AY 1 99 1 ) L A B O R ATO R Y T E C H N I C I A N I - II I

Provided QA, QC, R&D, and Manufacturing support for the companys intermediate
pharmaceutical manufacturing operations. For 4 years developed, installed, validated and
managed a Laboratory Information Management System (LIMS) that served the needs of over
100 users in 5 separate locations on the companys campus and over 50 remote locations for
the Animal Health Division. For 5 years developed, installed, validated and managed a
robotics system that provided automated analytical testing in a manufacturing environment.
Acted as the liaison between the QA/QC departments and the Animal Health and Information
Systems departments for all automation projects, as necessary. Provided documentation and
training to support company objectives in compliance to all government and company
regulations.
For 10 years provided support to production by testing manufactured compounds using Gas
Chromatography (GC), High Pressure Liquid Chromatography (HPLC), Infrared Spectroscopy
(IR), Refractometer, UV/Vis Spectrophotometer, coulimetric and volumetric titrators, pH
meters, and melting point apparatus among others. Designed, implemented and validated a
Zymark robotics application in the production facility to provide semi-automated testing with
little QC interaction. Wrote analytical methods, SOPs, validation protocols, and collaborated
in the development of a Laboratory Chemical Hygiene Plan. Helped develop and establish
the Animal Health Analytical laboratory by purchasing equipment, providing expertise and
support for robotics [Zymark], LIMS [LabSys LIMS/400], data acquisition [Perkin-Elmer
TurboChrom], and automated calculations [Excel spreadsheet and BASIC program].

L AR RY F O R T N E Y

R A I N I N G

R A I N E R

U.S. Department of Defense, Anti-Terrorism Level 1 Awareness Training (5/1/2009)

USDA Information Systems Security Awareness FY 2009 (12/29/2008)

Applied BioSystems, SQL*LIMS Building Templates, Orlando, FL (2002)

CimQuest, Inc., 21 CFR Part 11 Assessment Tool Training (2000)

Merck/Walsh Automation, Year 2000 Testing Workshop (1998)

15

University of Wisconsin, LIMS for Pharmaceutical / Biotech Industry: From Definition to

Validation (1998)
Magic Solutions, Help Desk Software Administrator Training (1997)

Confidence in Software, Inc., Testing Computer Systems in Pharmaceutical Applications,

Boston, Massachusetts (1996)

Mountain States Employee Council, Inc., Advanced Project Management, Denver, Colorado
(1995)

International Business Machines, Inc., Basic AS/400 Operations, Springfield, Missouri (1994)

DuPont Corp., Statistical Process Control, Springfield Missouri (1993)

International Business Machines, Inc., Query/400, Springfield, Missouri (1992)

Zymark Corp., Zymate II Programming (Robotics), Hopkinton, Massachusetts (1989)

ASQ Certified Quality Auditor (CQA)

Internal Trainer for 21 CFR Part 11

Internal Trainer for AS/400-based LIMS (LabSys LIMS/400)

E F E R E N C E S

Available upon request.