EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP Hardcover
暫譯: 歐盟附錄11全球健康機構GMP電腦驗證合規指南（精裝版）

This book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the Annex 11 guidelines into the computer validation program. The ideas presented in the book are based the author’s experience in the US Department of Defense and regulated industries in 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.