Welcome to GXP International !
The home of Common Sense Computer System Validation (CSV).
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.
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).
Her clients have come from across the pharmaceutical, Biotech, and Health Care Industries, and their system and service suppliers worldwide. 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.
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.
- 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
An Upcoming Conference In India:
26 & 27 Sept. 2019
At this conference Dr. Stokes will be giving 3 presentations:
• Validation and Reporting
• GAMP Methodology
• Data Integrity Masterclass
And participating in two panels.
4 Free CSV Articles
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.
Book Store - 8 CSV Units
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.
CSV Blog-40+ Indexed Topics
These Blog entries (2011-2015) are indexed for easy selection and may be printed for FREE to use in group study discussions. They explore quotes from the book Computer Validation: A Common Sense Guide and provide further training on CSV topics of interest.