AI in GMP: A Real-World Novo Nordisk Implementation

What happens when AI is introduced into GMP quality processes — in a controlled and compliant way?
In this session, Novo Nordisk shares a real-world case where AI has been implemented to support and improve quality processes across departments — resulting in measurable impact within months.

Key outcomes include:
• Improvement in Right First Time from 0% to 75%

• Reduced lead times across critical workflows

• Increased consistency and efficiency in quality-related tasks

The initiative was developed with limited resources and has since been expanded to multiple use cases.
This session goes beyond results and addresses the questions QA professionals are asking:

• How can AI be introduced in a GMP-regulated environment while maintaining compliance?

• How do you handle data integrity, security, and validation considerations?

• What kind of QA resistance and internal challenges can be expected — and how can they be managed?

• What are the current limitations, and what is required to reach full robustness?

• Which elements of this approach are transferable to small and mid-sized organizations?

• How can you as an organization, begin the above? Which tools are needed?

The session provides a balanced, experience-based perspective on both the opportunities and the constraints of using AI in quality environments today.

Inspection findings 2023-2026

- Current trends observed in GMP/GDP inspections

- Critical deficiencies and risk areas

- Evolving regulatory expectations and focus areas

- Deviations & findings that surprised us

Gain insight into how inspection focus is developing and what authorities are prioritising today.

Understand how to adapt your quality systems to meet increasing expectations and proactively address areas of risk ahead of future inspections.

Data integrity and quality systems – current inspection focus areas

Chairperson of Nordic Qaforum