| Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance Contributor(s): Lopez, Orlando (Author) |
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ISBN: 1498773249 ISBN-13: 9781498773249 Publisher: Productivity Press OUR PRICE: $171.00 Product Type: Hardcover - Other Formats Published: October 2016 |
| Additional Information |
| BISAC Categories: - Medical | Hospital Administration & Care - Medical | Pharmacology - Medical | Family & General Practice |
| Dewey: 610.285 |
| LCCN: 2016035531 |
| Physical Information: 372 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: 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. |