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, validation status, review trail and evidence. If that takes more than 48 hours, the system is probably not audit ready.
The key message is that AI governance is not just a compliance function. Done properly, it becomes a competitive capability, helping organisations deploy AI faster, safer and with greater trust.
Topics Covered
Why AI governance is more than frameworks and policies
The visible 20% vs the operational 80%
What auditors actually want to reconstruct
GxP expectations for AI systems
Validation, traceability and change control
Human oversight and decision accountability
Why governance must include how people use AI
Vendor selection and audit-ready AI
Why trust by design could become competitive advantage
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About the Podcast
AI For Pharma Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr Andree Bates, created to help pharma, biotech and healthcare organisations understand how AI-based technologies can save time, grow brands, and improve company results.This show blends deep sector experience with practical conversations that demystify AI for biopharma leaders, from start-up biotech right through to Big Pharma. Each episode features experts building AI-powered tools that are driving real-world results across discovery, R&D, clinical trials, medical affairs, market access, regulatory, insights, sales, marketing, and more.
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