By 2026, three significant updates to EU GMP will reshape the regulatory landscape for pharmaceutical companies:
– Chapter 4 introduces stricter lifecycle control for digital and hybrid documentation
– Annex 11 redefines expectations for computerized systems and cloud oversight
– Annex 22 sets the first formal requirements for AI in GMP environments
These updates mark a shift from procedural compliance to governed innovation, demanding strategic alignment across QA, IT, and data science.
In this white paper, our experts, Henrik Johanning and Per Damgaard from Epista Life Science, outline the key changes and their implications for your organization.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.
