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Cover image for book 21 CFR Part 11

21 CFR Part 11

Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
By:Orlando López
Publisher:Taylor & Francis
Print ISBN:9780367394592
eText ISBN:9781135488758
Edition:1
Copyright:2004
Format:Reflowable

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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 with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places