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Synopsis
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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- PublisherCreateSpace Independent Publishing Platform
- Publication date2017
- ISBN 10 1545359431
- ISBN 13 9781545359433
- BindingPaperback
- LanguageEnglish
- Number of pages62
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Data Integrity and GxP: An Introduction for the Life Sciences
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CreateSpace Independent Publishing Platform, 2017
ISBN 10: 1545359431
ISBN 13: 9781545359433
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Data Integrity and Gxp : An Introduction for the Life Sciences
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Data Integrity and GxP An Introduction for the Life Sciences
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Data Integrity and Gxp : An Introduction for the Life Sciences
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ISBN 10: 1545359431
ISBN 13: 9781545359433
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Data Integrity and GxP An Introduction for the Life Sciences
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Data Integrity and GxP: An Introduction for the Life Sciences
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Data Integrity and Gxp : An Introduction for the Life Sciences
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Data Integrity and Gxp : An Introduction for the Life Sciences
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