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Pharmaceutical Computer Systems Validation
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Pages: 773
Authors: Guy Wingate
Categories: Medical
Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press

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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
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Pages: 232
Authors: Orlando Lopez
Categories: Business & Economics
Type: BOOK - Published: 2018-10-02 - Publisher: Taylor & Francis

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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
Computer System Validation
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Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Language: en
Pages: 480
Authors: Stephen Robert Goldman
Categories: Business & Economics
Type: BOOK - Published: 2003 - Publisher: 1st Book Library

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This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutic
21 CFR Part 11
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Authors: Orlando López
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Type: BOOK - Published: 2004-01-15 - Publisher: CRC Press

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Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedur