Computer System Validation:Insight in Global Pharmaceutical Regulation
Paperback
Lieferzeit: Print on Demand - Lieferbar innerhalb von 3-5 Werktagen I
ISBN-13:
9783659467752
Veröffentl:
2013
Einband:
Paperback
Erscheinungsdatum:
10.10.2013
Seiten:
152
Autor:
Marmik V. Chaudhari
Gewicht:
244 g
Format:
220x150x10 mm
Sprache:
Englisch
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.