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Books, Electronic Training Chapters, and Briefings

Computer Validation: A Common Sense Guide. (Click graphic to order)
Dr. Teri Stokes, Published August 2011, (ISBN: 1-933722-54-1)

This is Dr. Teri Stokes' third book published August 2011 to celebrate the 15th anniversary of her global computer validation consultancy GXP International. The book’s ten chapters describe computer validation practices that field experience has shown to be practical to execute and that produce results which have passed audits and inspections. The twenty-nine chapter appendices provide full-scale examples of validation document sets, policies, and SOPs from real projects to illustrate the concepts discussed. Dr. Stokes' hard copy book provides a convenient reference for auditors, validation professionals, system providers, system users, third parties, and trainers of computer validation teams.

Electronic Training Chapters – Successful Computer Validation: A Common Sense Guide. (Click graphic to order) Dr. Teri Stokes, Published August 2011

To facilitate focused and distance learning, Dr. Teri Stokes' book is also available in PDF format as chapter groups in eight Working Brief Electronic Units. Trainers can then use the units as study materials to provide focused sessions and case studies for specific audiences. The book and units together provide a flexible program for training all parties on computer validation compliance to global regulations for pharmaceutical, medical device, and other life science industries. For a description of each briefing click here - Electronic Chapters: Working Brief Units

The Survive and Thrive Guide to Computer Validation
(Click graphic to order)
Teri Stokes
Published 1998 by Interpharm Press, Inc., now owned by CRC Press Customer Service: 1-800-272-7737

This is a practical text for CEOs and project teams looking for a rational approach to computer validation in regulated areas. With introductions by validation experts from Europe, Japan and the USA, this book describes a step by step approach to computer validation for laboratory, clinical, and manufacturing systems. The system sponsor's summary and conclusion for each chapter capture key content for a CEO. The body of each chapter discusses details for a project team with lots of graphics to illustrate the concepts. It is a book based on lessons learned from 8 years of real project experience across many companies and many countries.

Good Computer Validation Practices: Common Sense Implementation
(Click graphic to order)
Teri Stokes, Ron Branning, Ken Chapman, Heinrich Hambloch, Anthony J. Trill

This text examines the regulatory and practical issues involved in computer validation from a global perspective and provides a common sense approach to getting the job done. It combines the experiences and insights of an internationally respected group of computer system specialists, healthcare industry professionals, and a regulator. With SOPs, checklists, and a wealth of useful tips and hints, this book is essential for all computer systems management and staff.

Published 1994 by Interpharm Press, Inc., now owned by CRC Press Customer Service: 1-800-272-7737

Contributing Author to the following book:
Automation and Validation of Information in Pharmaceutical Processing
Published by Marcel Dekker, Inc., New York, NY, July 1998.

Executive Briefing : Computer Validation - The Big Picture
Teri Stokes
Published in 2000 by Davis Horwood Publications.

This 32 page briefing discusses risk management for electronic data and computerized systems from a corporate perspective. It gives practical guidance in how to assess the validation issue in project proposals for strategic systems in regulated areas and the ongoing effort required to keep such systems reliable. It also provides a step by step approach to developing a corporate policy on computer validation for those organizations subject to healthcare industry regulations.
Available at www.dhibooks.com.

Dr. Teri Stokes

GXP International

131 Sudbury Road

Concord, MA 01742 USA

Tel: +1-781-354-3537

Fax: +1-978-369-5620

Email: drstokes@gxpinternational.com