Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
Best Practices Guide to Electronic Records Compliance
Nonfiction, Health & Well Being, Medical, Reference, Hospital Administration & Care, Medical Science, Pharmacology
| Author: | Orlando Lopez | ISBN: | 9781315349978 |
| Publisher: | Taylor and Francis | Publication: | November 3, 2016 |
| Imprint: | Productivity Press | Language: | English |
| Author: | Orlando Lopez |
| ISBN: | 9781315349978 |
| Publisher: | Taylor and Francis |
| Publication: | November 3, 2016 |
| Imprint: | Productivity Press |
| Language: | English |
Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
