21 CFR Part 11 : Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Book Details
Format
Paperback / Softback
ISBN-10
0367394596
ISBN-13
9780367394592
Publisher
Taylor & Francis Ltd
Imprint
CRC Press
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Sep 23rd, 2019
Print length
260 Pages
Weight
453 grams
Product Classification:
Pharmaceutical technology
Ksh 12,250.00
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Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance.
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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