Inside Novo Nordisk's Digital Quality Management Strategy

Andrew Chang, senior director for Quality and Regulatory Affairs, Novo Nordisk, and Steven Falcone, head of the AIR-Q Group, Novo Nordisk, discuss Novo Nordisk's vision for a digitally connected manufacturing network and the role of real-time monitoring in modern pharmaceutical quality management.

Falcone gives a high-level overview of Novo Nordisk's quality management system, emphasizing the central role of process owners, cross-functional teams responsible for ensuring consistency across the company's global manufacturing network. These process owners oversee critical areas such as drug product sterility and manufacturing science and technology, working to align operations and set a shared direction for continuous improvement.

Falcone describes the real-time digital monitoring infrastructure in place across Novo Nordisk's fill-finish sites. Automated visual inspection systems examine every unit coming off production lines, while dense sensor networks track filling operations as they happen. "During the filling process, there's an incredible amount of sensors that are monitoring the performance of the filling operation in real-time digitally," Falcone explains. The company also utilizes tag rooms equipped with highly visible HMI screens and closed-circuit TV to give teams across different locations live visibility into manufacturing performance.

"We have a very big ambition to establish a globally interconnected digital network to support our manufacturing,” Chang continues. This vision, which includes a standardized manufacturing network, reflects Novo Nordisk's broader belief that real-time digital monitoring represents the future of pharmaceutical quality systems.

Chang adds an industry-wide perspective, noting that PDA's AI advisory and expert working group is actively engaging with regulatory agencies to help shape software validation requirements for manufacturing and quality management systems as guidance in this fast-evolving field continues to develop.