| Format | Hardcover |
|---|
Data Integrity and Compliance: A Primer for Medical Product Manufacturers
$114.70 Save:$25.00(18%)
Available in stock
| Print length: | 274 pages |
|---|---|
| Language: | English |
| Publisher: | ASQ Quality Press |
| Publication date: | 8 May 2019 |
| Dimensions: | 15.24 x 1.6 x 22.86 cm |
| ISBN-10: | 0873899873 |
| ISBN-13: | 978-0873899871 |
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Description
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. —- ISBN: 9780873899871 | ISBN10: 0873899873 | ISBN-13: 978-0873899871






