Data Integrity in Pharmaceutical and Medical Devices Regulation Operations:Best Practices Guide to Electronic Records Compliance

药物和医疗器械管理操作中的数据完整性:电子记录合规的最佳操作指南

药物化学

售   价:
1424.00
发货周期:预计5-7周发货
作      者
出  版 社
出版时间
2016年10月21日
装      帧
精装
ISBN
9781498773249
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页      码
394
开      本
7x10
语      种
英文
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图书简介
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.
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