Leveraging Enterprise AI in TMF Management: How Governance Enables Confidence and Compliance

About this session

Part of Session 6, Track E: TMF Validation and Governance (Chair: Lisa Mulcahy, Mulcahy Consulting).

AI has significant potential to transform TMF management , but confidence and compliance don't come from the technology. They come from the governance foundation built around it.
Two regulatory developments are raising the bar for what TMF teams must demonstrate. ICH E6(R3) expands essential records to include communications, decision rationale, and electronic data regardless of where they live. FDA's Remote Regulatory Assessment guidance creates mandatory response windows as short as 15 calendar days. Together, they mean TMF teams are accountable for surfacing evidence scattered across systems no single eTMF can see.
Enterprise AI, deployed as a governed knowledge synthesis layer across an eTMF and connected systems, enables teams to meet these demands , replacing days of manual searching with real-time, sourced, traceable answers that free TMF professionals for higher-value work. Real-life use cases will demonstrate governance methodology in practice, showing how AI-assisted TMF activities remain compliant, traceable, and inspection-ready.

Speakers

• BW

  Brittany Walker

  USDM

  Speaker

• LM

  Lisa Mulcahy

  Mulcahy Consulting

  Chair