Items related to Computer Infrastructure Qualification: For FDA Regulated...
Synopsis
Keeping computer infrastructure in a compliant state is becoming more of a key issue for both companies and regulatory authorities. Using a life cycle approach during Infrastructure Qualification Master Planning is vital to success. By bringing together risk analysis techniques, project management, infrastructure life cycle approaches, and resources management processes, companies can be assured of both a robust and compliant set-up.
This book, relevant to companies performing regulated operations, provides practical information to enable compliance with computer infrastructure requirements including the verification activities related with the design and deployment. A practical approach is presented to increase efficiency and to ensure that infrastructure development, verification, and maintenance is correctly achieved.
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About the Author
Orlando Lopez is now Director of Information Management at Cordis, a Johnson & Johnson Company in Miami Lakes, Florida. He is a member of the PDA Part 11 Core team, ISPE's Computer System Validation Sub-Committee (Delaware Valley Chapter) and Pharmaceutical Engineering Editorial Review Board. He is the author of seven books including such best-sellers as Qualification of Computer Networks, Retrospective Validation, and Computer Technologies Security Part 1 all published by SHPL Ltd, UK.
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