Welcome to GXP International !
The home of Common Sense Computer System Validation (CSV).
Dear GXP Colleagues, Clients, and New Friends,
Teri Stokes, Ph.D. brings to projects her skills as a recognized International Consultant, Author, Project Coach, Trainer, and Industry Speaker on the topic of computerized systems validation (CSV) and electronic data integrity. Her clients have come from across the pharmaceutical, Biotech, and Health Care Industries and their system and service suppliers worldwide.
Dr. Stokes’ 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, Electronic Records, and Data Integrity (GXP). For more than 20 years, successful projects, audits, and training engagements have been delivered for clients in North America, Europe, Japan, China, India and Africa.
In 2011, Dr. Stokes distilled her many years of CSV experience into her third book titled Computer Validation: A Common Sense Guide.
- Helping start-up and small companies new to GXP regulations for computer systems and data integrity compliance.
- Performing mock audits and third party audits of computerized systems and services.
- Training and project coaching in computer validation and formal testing practices for passing audits and inspections
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.
- Trainer: System & data compliance to GXP/CSV/FDA/EU standards
- Mentor/Coach: Computer validation projects, system teams & policy
- Auditor: Internal & external QMS for systems & data integrity
- Speaker/Writer: Invited presenter & author on CSV and e-Data Quality topics
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.