AI-Readiness in a Regulated World

For quality and compliance leaders in pharma and medical device, AI pressure is real and it’s coming from both directions: move too fast without the right governance in place and you’re inviting non-compliance; move too slowly and you’re handing competitive ground to peers who figured it out first. Most organizations are somewhere in the middle—experimenting with AI, leaning on existing or new vendors to add it to their systems, but operating without a clear framework for what “AI-ready” actually means in a regulated environment.

This practical session cuts through the noise. Jake Walton, VP of Quality & Compliance at MasterControl, will share a candid look at how MasterControl approached AI the right way from the start—building human-in-the-loop architecture as a non-negotiable design principle, aligning every capability to 21 CFR Part 11, EU MDR, GDPR, HIPAA, and other applicable standards, and going all the way through ISO 42001 certification for Artificial Intelligence Management Systems. Jake will walk through what that audit process actually looked like, the lessons learned, and what comes next as regulatory guidance continues to evolve—including the EU AI Act and emerging FDA guidance.

You’ll leave with a clear picture of what AI readiness really requires across your life sciences organization—from data quality and governance frameworks to change control, cross-functional ownership, and auditability—and a practical set of recommendations you can start acting on now.