21 CFR Part 11 : Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Book Details
Format
Hardback or Cased Book
ISBN-10
084932243X
ISBN-13
9780849322433
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Jan 15th, 2004
Print length
260 Pages
Weight
640 grams
Product Classification:
Mathematics & science
Ksh 36,000.00
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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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