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

Synopsis

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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About the Author

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.

"About this title" may belong to another edition of this title.