1. Vera Edelstein
382 Central Park West, Suite 9K
New York, NY 10025
Phone: 646-369-4171; e-mail: VEdelstein@aol.com
SUMMARY
Experienced leader, executive, manager, consultant, negotiator, and planner. Expert in information
systems, process quality assurance, computer systems validation, project management, change
management, strategic and business planning in multi-industry settings, such as telecommunications,
pharmaceuticals, and finance. Skilled in improving organizations' effectiveness, efficiency, profitability, and
bringing products and services to the market. Work effectively and communicate well with all levels of
management, possess strong interpersonal skills, and outstanding organizational skills. Managed multiple
projects with staff of 5 to 40, and operating budgets of $10 million and multi-million capital budgets.
PROFESSIONAL EXPERIENCE
Progenics Pharmaceuticals, Inc., Tarrytown, NY 5/07 - Present
Consultant (5/07 – 11/07) Sr. Manager Computer Systems Validation
 Responsible for corporate-wide validation and verification of computer systems
 Guided and/or developed validation/verification documentation including
developing/revising SOPs for the following projects:
• WinNonlin implementation of Equity Edge 7.0, GreatPlains 8.0,
• Core LIMS – initial, upgrades ADP, SAS 8.0, Oracle 9i)
• Talent Management Suite (TMS) • SAS 9.2 upgrade
• Rave-IxRS (EDC hosted) • ADP (web) upgrade
• DocCompliance- Clinical Study • Great Plains v. 10 upgrade
Report Repository • Equity Edge v. 8.0 upgrade
• DocCompliance – Certificate of • SuccessFactors
Analysis • FoundationIP
• DocCompliance - Performance • ClinTrial upgrades/enhancements
Enhancement and Upgrade v.4.4 • ClinTrace upgrades/enhancements
• System Retirement (older versions
VeraQual Associates, Inc., New York, NY 1/93 – 5/07
President, Management Consulting
[ ISO9000, IEEE, SEI/CMM, cGMP, cGLP, cGCP, 21 CFR Part 11, GAMP, Six Sigma, CRM, Siebel, TQM,
SDLC, QA, PMO, BPR, JAD, RAD, MS Project, PVCS, WinRunner, SAS, Oracle, Windows, 2000/NT/XP,
SUN Solaris, Visual Basic, HTML, JAVA, WinNonlin, abap, C/C++, client/server. HP, UNIX, NT, Lotus
Notes, Websphere, Documentum, DocCompliance, SAP, MES, I-Planet, UDB, UML, Rational, VPN]
For Fortune 500 companies (telecommunications, pharmaceutical, financial services) provided consultation
that improved efficiency, effectiveness, and significantly reduced cost:
6/05 – 4/07
Cytogen- Princeton, NJ, Provided assessment for a Documentum validation project
• Conducted audit of applications and business needs
• Provided assessment what validation needed to implement Documentum
Therics - Princeton, NJ Medical device certification project
• Provided analysis to certify to ISO 9001 or ISO 13485
• Provided gap analysis between what existed and what needed to be done to certify to ISO 13485
Geritrex –Mt. Vernon, NY, OTC pharmaceutical manufacturing – 21CFR Part 11 assessment
• Provided an assessment of compliance of the manufacturing to the FDA regulations
• Provided an assessment of compliance to 21CFR Part 11

2. QA/Validation Manager for CFR Part 11 projects [ISO9000, IEEE, SEI/CMM, cGxP,GAMP eCTD]
Clinical Systems /infrastructure (US, Japan) Eisai 7/03 – 6/05
• eDMS (Documentum) – provided validation and quality assurance guidance/auditing in the IQ/OQ/PQ
phases of the project; reviewed, revised and created SOPs (Change Management/Control, Managing
Physical/Logical Security, Maintaining Validated Server/Client, Backup/Restore/Disaster Recovery, Help
Desk, etc.) for CFR Part 11 project.
• Clintrial/dsNavigator integration– prepared Validation Plan and Validation Summary Report,
reviewed/created pre/post IQ/OQ/PQ test scripts and protocol;
• Statistical Systems validation project (SAS 8.0) – provided guidance in system development and audit
of cGxP documents.
• Served as advisor to project teams and provided direction in the system development, validation
approach, regulatory compliance and best practices for ARISg clinical safety system and Documentum.
• eDMS (Documentum) – phase 2 (publishing and scanning) – provided services in the area of gathering
user requirements, and system validation (review and/or authoring of URS, FRS, Validation Plan,
Validation Protocols and test scripts (IQ, OQ, PQ), Traceability Matrix, Summary Reports, and NDA
submission, for CFR Part 11 project.
QA/Validation Manager for 21CFR11, GAMP Manufacturing/infrastructure (US, Switzerland)
Novartis 10/02- 7/03
• Audited computer systems and directed staff to devise corrective action for compliance to 21CFR Part
11
• Directed and implemented cGXP compliance strategies and Remediation Plan for 21CFR Part 11 for
BPCS
• Directed staff and developed/reviewed validation documentation for both prospective/retrospective
validation (legacy systems). Prepared/reviewed: Quality Plan, URS, FRS, validation protocols, test
scripts/test results, Validation Summary Reports and SOPs
• Served as advisor to project teams and provided direction in the system development and validation
approach and best practices
Project Manager with responsibility for systems engineering, systems development & implementation,
quality process improvement, and off-shore systems development outsourcing at Financial Services Banking
Institution [ISO 9000, IEEE, SEI/CMM, Six Sigma] U.S. Trust 9/01 – 9/02
• Guided the development and implementation of systems engineering and process improvement
practice or the entire organization’s application systems
• Guided the development and implementation of CRM/Siebel project legacy interfaces
• Initiated and provided project management for the off-shore outsourcing of systems development and
support
Quality Manager with responsibility for quality management and process improvement initiatives in clinical
trial and research processes division. These include: (cGCP, cGLP, 21CFR11 ,SEI/CMM, ISO 9000)
Clinical Systems Merck 1/01 – 9/01
• Guided the development and implementation of computer Systems Life Cycle methodology and SOPs
• Audited computer systems and directed staff to devise corrective action for compliance to 21CFR Part
11 for Remote Data Entry (RDE), CDM and other Clinical Data Capture Systems used for
clinical trials
• Directed and implemented cGCP compliance strategies and Remediation Plan
QA/Validation Manager with responsibility for project/quality management and provided direction to project
team members in the validation approach/strategy and directed and managed testing, validation and
compliance best practices for Documentum – SmartSpace (EDMS98) (US, Puerto Rico, Ireland) web-based
project for managing company’s entire documentation (CMM, ISO 9000, MS Solutions Framework, cGMP,
cGCP, GAMP) Manufacturing/Clinical Schering-Plough 1/00 – 12/00
• Directed and implemented process improvement, and development of SOPs
• Implemented change control and management, version control, and document control
• Designed and developed test plans and protocols, test scenarios and test scripts
• Directed requirements/design/coding/testing best practices implementation
• Guided and written requirements specifications, validation plan, test plans/scripts, traceability, SOPs,

3. • Designed, developed, enhanced, and reviewed processes and procedures to meet cGMP compliance
per 21 CFR 820 and 21 CFR 11
• Interacted with all levels of management in numerous functions.
QA/Validation Manager/Validation Specialist - Designed and developed processes and procedures for
project management and quality assurance (QA), management and provided direction to project team
members in the validation approach/strategy and served as a knowledge base for validation and compliance
best practices across SAP™ - R/3, Documentum - Workspace projects, MES. These included: (21 CFR
Part 210, 211, 820, cGxP), (US, Puerto Rico, Ireland) Warner-Lambert(Pfizer) 1996-1999
• Designed, developed, and implemented computer system development lifecycle encompassing the
concept/planning phase through implementation, maintenance phases, and the retirement phase,
standard operating procedures, programming standards, documentation standards
• Directed and implemented cGMP, cGLP compliance, 21CFR Part 11, 21CFR 210, 211, 820, validation
plans and strategy, testing strategies and plans, staff training
• Directed requirements/design/coding/testing best practices implementation
• Directed development of disaster recovery, backup and restore, installation procedures (SOPs)
• Designed, and developed validation plans, test plans and protocols test scenarios and test scripts
• Implemented and managed project plans, schedules, resources, critical path, issue list
• Implemented change control and management, version control, and document control
• Designed/conducted technical reviews and audits
• Responded to auditors’ recommendations from the compliancy perspective
• Interacted with all levels of management in numerous functions
Provided consultation with the implementation of an innovative approach for strategic aligning of information
technology and business objectives. Designed and implemented practice to meet the needs of senior IT
executives - The Office of the CIO (EDS 1995 -1996)
• Instrumental in designing processes and procedures to insure smooth deployment, and coordinated
status meetings for a roll-out of lap-top computers to the EDS staff located World-wide
• ATT - for a new billing system consulted with the design and implementation of change management,
JAD and RAD; improved communication with users 1995 -1996
• Bellcore - advised/assisted with implementation of SEI/CMM/ISO 9000 in several engineering
departments; resulted in systems of better quality. 1993 - 1995
NYNEX Corporation [Verizon] - Science and Technology White Plains, N.Y. 1986 - 1993
Director, Infrastructure Operations and Management (established a brand new division)
Managed staff of 40 people, engaged in Project Management, Computer Systems Administration,
and Total Quality Management. Operating budget of $8M and capital budget of $30M
[ISO9000, IEEE, SEI/CMM, TQM, SDLC, PMO, BPR, JAD, RAD, Harvard PM, Oracle, C/C++,
client/server, SUN, HP, PCs, Ethernet, UNIX, NT, TCP/IP, NFS, FTP]
Bell Communications Research - Piscataway, New Jersey 1984 - 1986
District Manager, Advanced Telecommunications Network Planning
Managed staff of 40 people engaged in design, development and testing large scale applications,
operating budget of $8M, and capital budget of $4M [VAX, Unix, C/CC++, Fortran, Ingress]
EDUCATION
M.B.A. - Stern Business School, New York University, Executive Program, with highest honors
M.S. - Courant Institute, New York University, Computer Science, with honors
B.S. - Brooklyn College, Mathematics, Modern Languages, with honors
ISO 9000 Certified Lead Assessor
PROFESSIONAL ORGANIZATIONS
• IEEE, Computer Society, Sr. Member; Chairperson Software Maintenance Standard; Convener ISO
System Development Life Cycle processes
• Society of Women Engineers, Senior Member
• New York Software Industry Association – Past Member Board of Directors, Chair Export Committee
• American Society for Quality Control (ASQC), Member