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.
| Autorius: | José Rodríguez-Pérez |
| Leidėjas: | ASQ Quality Press |
| Išleidimo metai: | 2019 |
| Knygos puslapių skaičius: | 274 |
| ISBN-10: | 0873899873 |
| ISBN-13: | 9780873899871 |
| Formatas: | Knyga kietu viršeliu |
| Kalba: | Anglų |
| Žanras: | Quality Assurance (QA) and Total Quality Management (TQM) |
Parašykite atsiliepimą apie „Data Integrity and Compliance: A Primer for Medical Product Manufacturers“
