Complete Guide to International Computer Validation Compliance

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
2019-04-12 Pharmaceutical Validation Book or Program 1309 views Editor: Mohamed Atia


Orlando López

CRC Press 
Published January 15, 2004 
Reference - 243 Pages - 23 B/W Illustrations 
ISBN 9780849322433 - CAT# PH2243

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

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