AI is no longer a future concept in lifesciences, it’s actively being deployed across business processes from regulatory submissions to manufacturing monitoring to quality operations. But while adoption is accelerating, governance and validation approaches are struggling to keep up. Most organizations we work with today are under-validating AI.
Traditional software validation methods were built for deterministic systems. AI is different: probabilistic, data-dependent, and constantly evolving. This creates new risks, new expectations, and a new need for pragmatic, risk-based assurance strategies.
In this webinar, we have discussed:
- How AI actually works in GxP workflows
- Why validation must evolve (and how CSA fits in)
- What regulators are expecting and how leading organizations are responding
- And most importantly, how to actually perform assurance on AI-enabled systems
