21 CFR Part 11

副标题: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

ISBN: 9780849322433

出版社: Informa Healthcare

出版年: 2004-01-15

页数: 243

定价: USD 229.95

装帧: Hardcover

内容简介

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.