Dave Edwards on Why AI Readiness in Pharma Starts With Data and a Mindset Shift

Dave Edwards, CEO, MasterControl speaks with PharmTech at INTERPHEX 2026 about how AI is reshaping quality and manufacturing operations in regulated pharmaceutical environments. Edwards highlights that disconnected systems remain a core industry challenge, creating data silos that prevent companies from gaining a complete picture of quality and manufacturing performance, and sometimes driving workers back to paper-based processes.

He emphasizes that AI readiness begins with having data in digital systems, since AI cannot function without accessible, structured information. Beyond infrastructure, he stresses that an innovative mindset is equally essential, particularly given the caution warranted in regulated environments. MasterControl's approach keeps customer data contained within its own technology stack, preventing it from being shared across customers or used to train external models.

Edwards outlines several AI tools, including the Quality Event Summarizer, which provides operators with an at-a-glance overview of a quality event directly within their workflow screen, helping them work more efficiently without removing human judgment from the compliance process. A regulatory chat feature allows users to run operating procedures through an AI tool to identify potential compliance gaps. The company is also building a tool to convert paper manufacturing templates into digital formats operators can follow in real time, accelerating the paper-to-digital transition.

Edwards frames AI as an enabler and enhancer rather than a replacement for human workers, arguing that regulated environments will continue to require people but that AI can help them work smarter and solve problems more effectively.