From CSV to CSA: Streamlining software validation with a risk-based approach

n this expert session, Harsh Thakkar, CEO of Qualtivate and CSV expert, breaks down how to transition from traditional Computer System Validation (CSV) to the FDA’s modern, risk-based CSA (Computer Software Assurance) approach.

You’ll learn:

• What the FDA CSA guidance means in practice

• How to apply agile and risk-based validation techniques

• Ways to streamline vendor qualification and management

• How CSA reduces documentation burden while staying compliant

• Real-world steps to modernize your system validation process

Essential for quality and IT teams aiming to align with FDA’s future-forward validation expectations.