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CRC Press 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Name: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Brand: CRC Press

Computing & Internet

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Description

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.

Product Specifications

Brand: CRC Press
Format: paperback
ASIN: 0367394596
Category: Books > Subjects > Computing & Internet
Domain: Amazon UK
Release Date: 27 September 2019
Listed Since: 08 August 2019

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CRC Press 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

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