E225: The 80% Nobody Talks About: Building AI Governance That Survives a Pharma Audit
About this episode
Dr Andree Bates discusses AI governance in pharma with Nuno Valério, focusing on the operational aspects crucial for passing audits.
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. The discussion explores how AI governance is moving from strategy decks into implementation. Pharma teams are under pressure to turn AI into value, but in regulated environments the margin for error is close to zero. That means adoption, trust, validation, traceability and operational discipline all matter just as much as the model itself. Nuno also shares a practical way to pressure test readiness: take an AI tool already in production, pick a decision from a few months ago, and try to fully reconstruct the inputs, model version…
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