Additional information
| Full Title | Data Integrity and Compliance A Primer for Medical Product Manufacturers |
|---|---|
| Author(s) | José Rodríguez-Pérez |
| Edition | |
| ISBN | 9781951058470, 9780873899871 |
| Publisher | ASQ Quality Press |
| Format | PDF and EPUB |
Availability: In Stock
Data Integrity and Compliance A Primer for Medical Product Manufacturers
SKU: 9781951058470
Original price was: $60.00.$24.99Current price is: $24.99.
Access Data Integrity and Compliance A Primer for Medical Product Manufacturers Now. Discount up to 90%
Book Information
Description
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.
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Data Integrity and Compliance A Primer for Medical Product Manufacturers
SKU: 9781951058487
Original price was: $60.00.$24.99Current price is: $24.99.
Access Data Integrity and Compliance A Primer for Medical Product Manufacturers Now. Discount up to 90%
Book Information
Additional information
| Full Title | Data Integrity and Compliance A Primer for Medical Product Manufacturers |
|---|---|
| Author(s) | José Rodríguez-Pérez |
| Edition | |
| ISBN | 9781951058487, 9780873899871 |
| Publisher | ASQ Quality Press |
| Format | PDF and EPUB |
Description
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.
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