Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance
Orlando Lopez
ISBN: 9781498773249
Vydavateľstvo: Taylor & Francis
Rok vydania: 2016
Vydanie: 1
Väzba: Hardback
Počet strán: 394
Pôvodná cena: 137,81 €
Výstavná cena:
124,03 €(t.j. po zľave 10%)
(Cena je uvedená vrátane 10% DPH)
Katalógová cena: 105 GBP
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Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.