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White Paper
A Governance Framework for Agentic AI in GxP Environments
Controls, audit trails, validation, and reviewer escalation across the agent lifecycle.
32 pagesApril 2026White Paper
About this white paper
What's inside
Controls, audit trails, validation, and reviewer escalation across the agent lifecycle. This research-grade white paper distills field experience from production deployments into a structured framework your clinical, biometrics, QA, and IT leaders can act on this quarter.
Key takeaways
What you'll learn
- A reference framework for governing agentic AI in GxP-regulated workflows.
- Reviewer-in-the-loop patterns that hold up to internal audit and inspection.
- Validation, audit-trail, and escalation controls across the agent lifecycle.
- Quantified impact on cycle time, cost, and quality across recent deployments.
- A 90-day implementation path from pilot to production rollout.
About the author
Marcus Lehmann
Principal, Biometrics Strategy
Marcus has 18 years in clinical biometrics across Top-20 pharma and global CROs. He writes about agentic delivery models for SDTM, ADaM, and TLF.
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