Welcome to GXP International !
The home of common sense Computer System Validation (CSV).
Dear GXP Colleagues, Past Clients, and New Friends,
This website has been created to stay in touch with all of you for sharing new electronic data integrity ideas and new validation experiences acquired as Dr. Stokes moves from her consulting business to her corporate role as Director of Quality Assurance and Compliance at Cytel, Inc.
This website also aims to provide the essence of common sense Computer System Validation methods and practices to new people coming into the quality assurance profession focused on electronic data integrity and Computerized System Validation.
As new people surf the web with computer validation questions they will find this website a CSV resource with some answers and practical suggestions for FDA Part 11 and EU GMP Annex 11 compliance.
This website’s information is based on Dr. Stokes’ 30+ years of active work in auditing, teaching, and coaching computer validation projects for biotech, pharmaceutical, and medical device companies around the world.
To converse with Dr. Stokes, go to the Chat section of this site and send an email with your comments and questions. It will be a pleasure to hear from you and to share insights.
Teri Stokes, Ph.D.
Dr. Teri Stokes
131 Sudbury Road
Concord, MA 01742
USA Tel: +1-781-354-3537
What is Common Sense?
Common sense is knowledge based on “native good judgment” and personal experience. It is that combination of “book” smart, “street” smart, and “work” smart that a person can apply to scoping computer validation projects.
A four part series of articles by Dr. Stokes, published in Applied Clinical Trials concisely describes the common sense approach to CSV packages. These articles are available for free download.
The Book Store section provides the opportunity to purchase CSV Training Units based on book chapters from Computer Validation: A Common Sense Guide. The Units are designed to support focused and distance CSV learning.
A series of blogs written from 2011 to 2015 were used to explore quotes from the book. These entries provide further training on CSV topics of interest to new and experienced QA professionals.