The 80% Nobody Talks About: Building AI Governance That Survives A Pharma Audit

In this episode of AI For Pharma Growth, Dr Andree Bates speaks with Nuno Valério, Head of Innovation, R&D Quality at Merck Healthcare, about the part of AI governance most organisations rarely talk about: the operational 80% that decides whether AI survives a pharma audit.

Nuno explains why governance cannot stop at policies, committees, risk frameworks and model registers. Those visible elements matter, but they are only the start. In a GxP environment, auditors will want to reconstruct how a decision was made, which data was used, which model version was involved, what validation evidence exists, and where the human decision trail sits.