Pharmaceutical Computer Systems Validation
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Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri
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Type: BOOK - Published: 2018-10-02 - Publisher: Taylor & Francis
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of
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Type: BOOK - Published: 2003 - Publisher: 1st Book Library
This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutic
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Pages: 287
Pages: 287
Type: BOOK - Published: 2004-01-15 - Publisher: CRC Press
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedur