Computer System Validation According to GAMP 5 - Handbook

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Why download?

Gain a clear understanding of Computer System Validation (CSV) in life sciences with this handbook by Scilife's GAMP 5 specialists. Learn about:

The critical role of CSV in ensuring product safety, efficacy, and compliance
GAMP 5’s five risk-based categories and how they apply to system validation
Key operational procedures, including change control, risk management, and periodic review
Key validation deliverables, activities, and best practices for each phase
The V-model and Agile model for system development in CSV

You’ll also get answers to frequently asked questions about CSV implementation and challenges!