Dr. Teri Stokes is an International Consultant on the topic of computer systems validation to the pharmaceutical, biotech, and health care industries and their system suppliers. Her special focus is the development of corporate policy and its practical implementation through to project level activities across international sites for systems operating under regulations for GLP, GCP, GMP, and Electronic Records. Successful engagements have been delivered for clients in North America, Europe, and Japan.
Dr. Stokes established her own consulting firm GXP International in March 1996 after more than 16 years with Digital Equipment Corporation where her last assignment was as Director of Computer Validation Services in the Americas. From May 1990 to June 1995, she worked for Digital in Basel, Switzerland and established Digital’s validation services business in Europe. During 1993-95, Dr. Stokes served as a Founding Member on the Board of Directors of the European Forum for Good Clinical Practice (EFGCP) in Brussels, Belgium and participated in the Audit Working Group of the EFGCP.
Prior to coming to Digital in 1979, Dr. Stokes had a 12 year management career in hospital and commercial medical laboratories in the USA. Her introduction to computers came within a GLP environment where laboratory testing for 2,000 patients per day was performed. The computer systems for this laboratory also transmitted report results to 21 remote sites.
In her 16+ years at Digital, Dr. Stokes kept a focus on the pharmaceutical, biotech, and chemical industries across her various assignments. She holds a B.A. degree in Biology from Boston University and a professional registration as a Medical Technologist, M.T.(ASCP). Dr. Stokes received her M.S. degree in Management in 1987 from Lesley University with a marketing thesis on Remote Data Entry in Clinical Trials: Technology ; Market Readiness. In 1991 she received her Ph.D. in Management from Walden University with a Dissertation titled “ Clinical Data Management Trends: New Technologies and EC 1992.;
Professional Memberships:
Drug Information Association (DIA) – Member since 1982and on Core Committees for Validation and GCP/QA
American Society of Quality (ASQ) – Member & Speaker at 2007 Annual Meeting
Institute of Electrical and Electronics Engineers (IEEE) – Member and on Rewrite Committee for Std. 829 Test Documentation
National Institutes of Health (NIH) - Peer Reviewer for grant proposals
Book Author:
Sole author of the book titled The Survive and Thrive Guide to Computer Validation published by Interpharm Press, Inc., Englewood, CO, June 1998. ISBN: 1-57491-067-1 Available at www.gxpinternational.com
Lead Author of the book Good Computer Validation Practices: Common Sense Implementation published by Interpharm Press, Inc., May 1994. ISBN: 0-935184-55-4
Contributing Author to the following books:
Computerized Systems Used in Nonclinical Safety Assessment: Current Concepts in Validation and Compliance published by Drug Information Association, 2008. Chapter 6: Business Continuity and Disaster Recovery.
Pharmaceutical Quality published by DHI Books and PDA Press, June 2004.
Chapter 13: Quality for Computerized Systems and Electronic Data in Regulated Environments. 
Automation and Validation of Information in Pharmaceutical Processing published by Marcel Dekker, Inc., New York, NY, July 1998. Chapters 15: GMP Regulations and Computer Validation, Chapter 17: Management’s Role in Computer Validation: Policy and Procedures, Chapter 18. Electronic Records, Electronic Signatures, and FDA Regulation Final Rule.
Multi-Company, Multi-Country Clinical Trials: Implementation, Monitoring, and Regulations published by Interpharm Press, Inc., July 1993. Chapter 12: Information Systems Validation in Global Clinical Trials.