Data Integrity and GxP

An Introduction for the Life Sciences

By: Mr Brendan Cooper

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Paperback | 13 April 2017

At a Glance

Paperback
62 Pages

Dimensions(cm)
22.86 x 15.24 x 0.33

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$113.75

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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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