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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
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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
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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
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
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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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Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedur