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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)
- Format: Pocket/Paperback
- ISBN: 9781545359433
- Språk: Engelska
- Antal sidor: 62
- Utgivningsdatum: 2017-04-13
- Förlag: Createspace Independent Publishing Platform