Computer System Validation:Insight in Global Pharmaceutical Regulation

Marmik V. Chaudhari (u. a.)

ISBN 10: 3659467758 / ISBN 13: 9783659467752

Published by LAP LAMBERT Academic Publishing, 2018

About this Item

Computer System Validation:Insight in Global Pharmaceutical Regulation | Marmik V. Chaudhari (u. a.) | Taschenbuch | 152 S. | Englisch | 2018 | LAP LAMBERT Academic Publishing | EAN 9783659467752 | Verantwortliche Person für die EU: BoD - Books on Demand, In de Tarpen 42, 22848 Norderstedt, info[at]bod[dot]de | Anbieter: preigu.

Seller Inventory # 113179161

Bibliographic Details

• Title: Computer System Validation:Insight in Global Pharmaceutical Regulation
• Publisher: LAP LAMBERT Academic Publishing
• Publication Date: 2018
• Language: English
• ISBN 10: 3659467758
• ISBN 13: 9783659467752
• Binding: Taschenbuch
• Condition: Neu
• Dimensions: 220W x 150H x 10D millimeters 220 millimeters width by 150 millimeters height by 10 millimeters depth
• Weight: 244 grams
• Seller catalogs:
  • Bücher

About this title

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.

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.