AI at the Crossroads of Regulation and Innovation

AI is rapidly reshaping life sciences manufacturing—but as intelligent systems move into regulated environments, questions around validation, governance, and trust become unavoidable.

In this episode of Augmented Ops, host Michelle Vuolo, Head of Quality at Tulip, is joined by Bryan Ennis, Chief Quality Officer and Founder of Sware, and Martin Heitmann, industry expert and co-lead of the ISPE GAMP AI Guide. Together, they explore what it really takes to deploy AI responsibly in pharma, biotech, and medtech operations.

The conversation examines why many AI initiatives stall at the pilot stage, how validation practices must evolve for probabilistic systems, and where organizations are already seeing real value—from predictive maintenance to quality signal detection and validation automation. They also discuss emerging regulatory guidance, including Annex 22, and why regulators are not anti-AI—but deeply skeptical of black-box systems.

Throughout the discussion, a consistent theme emerges: successful AI adoption is less about the technology itself and more about process design, data quality, human oversight, and building evidence that systems are safe, transparent, and fit for purpose.

This episode offers a grounded, experience-driven perspective on how life sciences organizations can move from experimentation to scale—without compromising patient safety or compliance.

Watch the full episode on YouTube: https://youtu.be/7keK_4zDaTg

Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone else that cares about what the future of frontline operations will look like across industries. This show is presented by Tulip, the Frontline Operations Platform. You can find more from us at Tulip.co/podcast or by following the show on LinkedIn.