RPA Validation in Life Sciences: 5 Pitfalls and How to Avoid Them

The issue with RPA was discovered during an FDA audit at a Global Biotech company. There was a lack of validation documentation, requirement traceability, and testing, and missing evidence. That’s when it was noted that a successful automation project is indeed a regulatory finding. 

This is not an unusual event in life sciences; bots aren’t just scripts, they are regulated systems. The development should include compliance, risk management, and audit readiness, as with any other GxP systems.