EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

This book provides practical information to enable compliance with computer systems requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. The ideas presented in this book are based on the author¿s twenty five years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. A practical approach is presented to increase efficiency and to ensure that software development and maintenance is achieved correctly.