Leveraging AI in Risk Assessment for Smarter Computer Systems Validation

Description

This course shows how AI can be applied responsibly to risk assessment in computer systems validation, replacing static scoring with evidence-driven decisions. It equips teams to build defensible, inspection-ready risk models that align with CSA expectations while strengthening data integrity, validation focus, and FDA confidence.

WHY YOU SHOULD ATTEND:

Risk assessment sits at the center of computer systems validation, yet many organizations still rely on subjective scoring, outdated templates, and assumptions that no longer reflect how modern GxP systems behave. As systems grow more complex, traditional approaches struggle to keep pace.

Teams often misapply CSA by speeding validation without strengthening risk logic. Gaps emerge when risk models cannot explain why controls exist, how failure likelihood was assessed, or how data was evaluated—issues that surface quickly during FDA inspections.

This webinar brings practical clarity to using AI as a decision-support tool in validation risk assessment. It sharpens judgment, improves objectivity,…