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Data Integrity and GxP|Brendan Cooper

Data Integrity and GxP : An Introduction for the Life Sciences

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Overview

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)

This item is Non-Returnable

Details

  • ISBN-13: 9781545359433
  • ISBN-10: 1545359431
  • Publisher: Createspace Independent Publishing Platform
  • Publish Date: April 2017
  • Dimensions: 9 x 6 x 0.13 inches
  • Shipping Weight: 0.21 pounds
  • Page Count: 62

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