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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 |
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 |
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