Data Integrity and GxP: An Introduction for the Life Sciences

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
Publisher: Createspace Independent Publishing Platform
Published: 04/13/2017
Pages: 62
Binding Type: Paperback
Weight: 0.21lbs
Size: 9.00h x 6.00w x 0.13d
ISBN13: 9781545359433
ISBN10: 1545359431
BISAC Categories:
- Science | Biotechnology

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