Title: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Publisher: CRC Press 2019-08-30
Publication Date: 2019
Language: English
ISBN 10: 0367394596
ISBN 13: 9780367394592
Binding: Paperback
Condition: New

About this title

Synopsis

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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L�pez, Orlando

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