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

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

Hardcover

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Product Details

ISBN-13: 9780849322433
Publisher: Taylor & Francis
Publication date: 01/28/2004
Pages: 243
Product dimensions: 7.20(w) x 10.10(h) x 0.80(d)

Table of Contents

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate 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. The material is presented through 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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