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Computer System Validation:Insight in Global Pharmaceutical Regulation
Taschenbuch von Marmik V. Chaudhari (u. a.)
Sprache: Englisch

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Beschreibung
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.
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.
Über 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.
Details
Erscheinungsjahr: 2013
Fachbereich: Toxikologie
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: 152 S.
ISBN-13: 9783659467752
ISBN-10: 3659467758
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Chaudhari, Marmik V.
Patel, Keyur N.
Raval, Bhuvan P.
Hersteller: LAP LAMBERT Academic Publishing
Maße: 220 x 150 x 10 mm
Von/Mit: Marmik V. Chaudhari (u. a.)
Erscheinungsdatum: 10.10.2013
Gewicht: 0,244 kg
Artikel-ID: 113179161
Über 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.
Details
Erscheinungsjahr: 2013
Fachbereich: Toxikologie
Genre: Medizin
Rubrik: Wissenschaften
Medium: Taschenbuch
Inhalt: 152 S.
ISBN-13: 9783659467752
ISBN-10: 3659467758
Sprache: Englisch
Ausstattung / Beilage: Paperback
Einband: Kartoniert / Broschiert
Autor: Chaudhari, Marmik V.
Patel, Keyur N.
Raval, Bhuvan P.
Hersteller: LAP LAMBERT Academic Publishing
Maße: 220 x 150 x 10 mm
Von/Mit: Marmik V. Chaudhari (u. a.)
Erscheinungsdatum: 10.10.2013
Gewicht: 0,244 kg
Artikel-ID: 113179161
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