Building Agility into Quality Management at Novo Nordisk

Novo Nordisk’s insulin pen and biologics therapies broke new ground in the 1980s, empowering diabetic patients to take charge of their own treatment. Much has changed since then. The company now relies on CDMOs to help it scale up manufacturing in novel therapeutic areas. Its work in stem cell therapy, for example, is taking Novo Nordisk’s quality team into areas where GMP guidelines do not yet exist. At Veeva Systems’ 2022 R&D and Quality Summit in Zurich, Poul Henning Poulsen, vice president of quality systems, shared how Novo Nordisk is using cloud technologies to meet new priorities and scale its quality operations for the future.

Whether dealing with hard-core GMP requirements at a biologics facility or managing stem cell differentiation at a hospital, agile quality management is essential to understanding processes and managing risk. The key is establishing the right balance between the rigor and structure required for mature products and the agility and flexibility needed for new products. “It can be a tough balancing act,” he said.

Simplifying processes and pruning SOPs

Achieving agile, responsive quality operations requires simplifying and standardizing processes so that they can be stabilized and aligned to each product, enabling smoother technology implementation. In the past, Poulsen explained, Novo Nordisk loaded every new quality requirement and rule into its legacy QMS. The result was a complicated patchwork. “Every time an issue came up, we would add a new paragraph to an SOP or even create a new QMS document,” he said. Eventually, complexity reached the point where the average employee had to be trained on at least 70 different SOPs. Manufacturing staff had to master more than 150.

Since 2008, the company has eliminated unnecessary complexity without oversimplifying processes. Currently, Poulsen said, company employees train on 29 or fewer SOPs, which are also shorter and sharper, and have resulted in better inspection performance. Novo Nordisk’s quality department prevents scope creep by appointing gatekeepers in different subject areas to review any proposed changes and ensure that SOPs remain as tight and focused as possible.

Focus on patients, not specs

As it adjusts to market changes, Novo Nordisk’s quality strategies are increasingly focused on the patients who use its products every day. Establishing a quality culture and the clear understanding that every employee is responsible for quality is a primary goal. The effort is now based on quality risk management, which began with risk mapping and assessment.

Currently, Poulsen says, the company can manage quality risk well when it is introducing new products and facilities, but he wants to achieve integrated quality management to extend this ability throughout the product lifecycle. In the past, with manual systems and spreadsheets, even attempting to achieve the level of understanding required was extremely difficult. “We needed an electronic system to be able to capture, analyze, and mitigate risk,” he said.

Uniting risk and knowledge management

By managing quality risk in the same system that manages quality issues, such as complaints, the company can integrate knowledge gained from resolving past problems into its risk management system. Having quality and risk management in one place also emphasizes the connection between them, so that issues with quality prompt closer determination of risk. “When quality issues come up, they should make users consider how fully they understand the risk picture,” Poulsen commented.

As it evolves, the modern eQMS also functions as a central knowledge management system for products, Poulsen said. This is especially useful for new types of therapies, which don’t have a long history or established quality practices. “It’s a place where you can look at your change requests and evaluate them based on the pre-existing risk picture, so that you thoroughly evaluate any change that needs to be made,” he said. It’s also crucial for connecting sponsors with contract partners, to provide both sides with transparency on quality issues as they develop.

Using a SaaS approach has freed Novo Nordisk’s team from having to manage the overall application, as well as expensive updates and upgrades. But, on a deeper level, a unified quality management and documentation system is improving transparency and collaboration, internally and with partners, as the company moves into new areas of R&D and manufacturing.

Watch Poulsen’s keynote.