Episode Details

To err is human. To make things up is AI. So in a regulated industry, how should the two work together?

In this episode, host Chris Adkins talks with David Dlugo, Senior Director of Quality Assurance at Kymanox, about using AI responsibly in a regulated industry. David explains why every AI output at Kymanox gets reviewed by a seasoned expert. He also walks through a “two-part authentication” approach, where an AI review and a human review are checked against each other. And he shares where AI saves real time in SOP drafting, and where it saves none.

They also cover:

• Where AI fits in quality work today: QMS, batch record review, CAPAs, deviations, and complaint handling
• Why the bot should never make the call in quality decisions
• What changes for the people doing the work, and what doesn’t
• How to vet AI vendors when everyone is promising the world

Presented by Kymanox. Produced by Walk West.