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

 
Author(s)  López, Orlando
Publisher  Taylor & Francis Group
Publication year  2005
Language  en
Edition  1
Page amount  287 pages
Price  163,84 €

     0-203-02677-2
 
 
DRM Restrictions
Printing  Allowed without restriction
Copy to clipboard  Allowed without restriction
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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