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Data Integrity and GxP: An Introduction for the Life Sciences

Data Integrity and GxP: An Introduction for the Life Sciences

Paperback

Biology

ISBN10: 1545359431
ISBN13: 9781545359433
Publisher: Createspace
Published: Apr 13 2017
Pages: 62
Weight: 0.21
Height: 0.13 Width: 6.00 Depth: 9.00
Language: English
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)

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Biology