Data integrity and compliance : a primer for medical product manufacturers /
Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by m...
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| Format: | eBook |
| Language: | English |
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Milwaukee, Wisconsin :
ASQ Quality Press,
2019.
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| Online Access: | Connect to the full text of this electronic book |
| Summary: | Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance. |
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| Physical Description: | 1 online resource (278 pages) : illustrations |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 1523132337 9781523132331 |