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Focusing on the comprehensive validation process, this book guides readers through each phase, from planning and implementation to ongoing calibration and change control. It addresses international and FDA regulations, offering practical examples to ensure compliance with FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. Included templates and checklists provide essential documentation and help readers systematically cover all validation aspects, ensuring an efficient and cost-effective approach to meeting regulatory requirements.
Nákup knihy
Validation of Computerized Analytical Systems, Ludwig Huber
- Jazyk
- Rok vydania
- 2019
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- Titul
- Validation of Computerized Analytical Systems
- Jazyk
- anglicky
- Autori
- Ludwig Huber
- Vydavateľ
- CRC Press
- Rok vydania
- 2019
- Väzba
- mäkká
- Počet strán
- 268
- ISBN13
- 9780367401726
- Kategórie
- Biológia
- Anotácia
- Focusing on the comprehensive validation process, this book guides readers through each phase, from planning and implementation to ongoing calibration and change control. It addresses international and FDA regulations, offering practical examples to ensure compliance with FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. Included templates and checklists provide essential documentation and help readers systematically cover all validation aspects, ensuring an efficient and cost-effective approach to meeting regulatory requirements.