Data Integrity and GxP: An Introduction for the Life Sciences (Paperback) (ISBN-13: 9781545359433)

This concise pocket book is a perfect introduction to Data Integrity in a GxP environment. It summarises key definitions and concepts from FDA and Eudralex regulatory requirements. Data Integriy and Data Reliability are increasingly seen as a critical aspect in ensuring patient health and safety. This book clearly outlines the fundamentals of Data Integrity, required to be Accurate, Attributable, legible, contemporaneously recorded, original or a true copy(ALCOA). In addition, the requirements of Computerised systems are summarised through a lifecycle approach. All-in-all a concise guide for any Engineering or Science professional. (Size 5" x 8" Paperback)

Author: Brendan Cooper
ISBN-10: 1545359431
ISBN-13: 9781545359433
Publisher: Createspace Independent Publishing Platform
Language: English
Published: 04/13/2017
Pages: 62
Format: Paperback
Weight: 0.21lbs
Size: 9.00h x 6.00w x 0.13d