Crafting a more practical, Risk-Based Approach to Computer System Validation
Data and documentation are the most critical elements in ensuring pharma and life science systems are managed in a safe, effective, and compliant way.
The introduction of new FDA guidance and the industry’s reliance on computer-based digital systems has significantly impacted how pharmaceutical companies need to validate their digital information.
Trevor Marshall, Head of Consulting for Life Science Manufacturing at Cognizant, tells us why he thinks the industry has an appetite for a change in data validation and outlines how best practice, risk-based approaches can help shift CSV quality systems management into a more efficient and compliant gear.
Read the full article on pages 1- 2 and find out more about Trevor’s viewpoint on implementing and managing CSV.