Catalent launches enterprise AI tool to strengthen quality management systems

Catalent, a global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida, has launched Qai, an enterprise artificial intelligence (AI) tool designed to support quality management system processes across its manufacturing network.

Qai is built using Microsoft AI technologies powered by Azure, including Microsoft Foundry, with supporting data and analytics capabilities from Microsoft Fabric, according to the announcement. The tool is designed to analyze Catalent’s enterprise data to accelerate root cause identification and corrective and preventive action development for quality processes such as deviations and complaints, the company said. Qai is Catalent’s first enterprise AI solution.

The platform integrates AI-driven insights into existing quality workflows, which the company said is intended to improve root cause analysis to reduce repeat deviations, accelerate reporting, and reduce documentation delays.

Charlie Lickfold, chief technology officer at Catalent, said in a statement the launch of Qai represents a step in how the company is applying AI technologies across its operations to improve consistency, accelerate insight, and support decision-making.

Todd Mersch, general manager of U.S. life sciences and nedtech at Microsoft, said in a statement Qai reflects an application of AI intended to strengthen data analytics and governance across manufacturing processes.

In a July 2025 interview with Pharma Manufacturing, Catalent CEO Alessandro Maselli said AI is having a profound impact on the CDMO space and that his company has been an early adopter of the technology, which he sees as a competitive advantage.

“Catalent is implementing AI in our workforce to increase productivity and accomplish more with their time, while providing a better work-life balance,” Maselli said. “On the shop floor, AI is helping us to leverage the tremendous amount of data we generate each day in order to identify improvements that we can bring to optimize our processes. I believe it’s going to be transformational for us.”

AI is increasingly being utilized in pharmaceutical manufacturing as drug manufacturers look to make production faster, more reliable, and easier to manage, according to a new report from data and analytics firm GlobalData. Digital twins, predictive maintenance, and real-time quality monitoring are being used to minimize downtime, reduce waste, and improve batch consistency.