How AI Is Transforming Biopharma Quality and Compliance

As a part of PDA Week 2026, Christopher Lewis, Emoja Biopharma and President of the Mountain States PDA Chapter, sat down with PharmTech to share his perspective on the growing role of AI in pharmaceutical quality and compliance operations.

At the heart of Lewis's viewpoint is the importance of keeping humans meaningfully involved as AI takes on a larger role. "Having human-in-the-loop at each one of those steps ensures there's a balanced approach to the risk-based model of implementing AI in the environment in which we operate," he explains.

When it comes to measuring success, Lewis points to several key metrics: investigation cycle time, hands-on labor hours, and recurrence rates for deviations and related investigations. He notes that recurrence rates might actually rise initially as AI surfaces patterns that human reviewers previously missed, a sign the tools are working, not failing. Over time, he expects those numbers to decline as root causes are more thoroughly identified and addressed.

Lewis also reflects on the presentation he moderated, showcasing real-world AI deployments in quality operations. "Companies are now putting that into use to save time, to repurpose expertise, and to really drive at increasing the quality framework," he says. What stands out to him was the shift from theoretical discussion to practical implementation, highly skilled workers being freed from repetitive tasks to focus on higher-value work. For Lewis, that transition represents a meaningful step forward for the industry.