Scilife Handbook

Computer System Validation (CSV) according to GAMP 5 

 

Enter your details below to receive your free handbook instantly via email. Gain the knowledge to implement a robust and efficient CSV process. 

CSVIntro to Data Integrity Handbook
CSVIntro to Data Integrity Handbook2
CSVIntro to Data Integrity Handbook3

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!

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