Books & Briefings

The Survive and Thrive Guide to Computer Validation (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 (Order)

Teri Stokes, Ron Branning, Ken Chapman, Heinrich Hambloch, Anthony J. Trill
Published 1994 by Interpharm Press, Inc., now owned by CRC Press Customer Service: 1-800-272-7737

Order The Survive and Thrive Guide to Computer Validation Book
$237 plus shipping and handling

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

Available at www.crcpress.com

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.