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 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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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 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.
45.49
In Stock
5
1
Data Integrity and Compliance: A Primer for Medical Product Manufacturers
279
Data Integrity and Compliance: A Primer for Medical Product Manufacturers
279
45.49
In Stock
Product Details
| ISBN-13: | 9781951058487 |
|---|---|
| Publisher: | ASQ Quality Press |
| Publication date: | 05/08/2019 |
| Sold by: | Barnes & Noble |
| Format: | eBook |
| Pages: | 279 |
| Sales rank: | 743,415 |
| File size: | 738 KB |
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