Computer System Validation:Insight in Global Pharmaceutical Regulation - Softcover

Chaudhari, Marmik V.; Patel, Keyur N.; Raval, Bhuvan P.

9783659467752: Computer System Validation:Insight in Global Pharmaceutical Regulation

Softcover

ISBN 10: 3659467758 ISBN 13: 9783659467752

Verlag: LAP LAMBERT Academic Publishing, 2013

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Computer System Validation is a mandatory requirement as per various regulatory authorities. Major ones are USFDA, EMEA, Swissmedic and Health canada. This book is based on generally recognized software validation principles and, therefore, can be applied to any software. This guidance applies to any software related to a regulated medical device, It does not specifically identify which software is or is not regulated.

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�ber die Autorin bzw. den Autor

Marmik V. Chaudhari (M.Pharm) and Keyur N. Patel (M. Pharm) are PG Students at Faculty of Pharmacy, SRI Campus, Vadasma. Dr. Bhuvan P. Raval, M.Pharm, MBA, PGDPRA, FSAB, FICPHS, D.Lit is an Asst. Professor at Faculty of Pharmacy, SRI Campus, Vadasma.

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