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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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21 CFR Part 11 - Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Hardcover)
Loot Price: R5,292
Discovery Miles 52 920
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21 CFR Part 11 - Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry (Hardcover)
Expected to ship within 12 - 17 working days
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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 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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