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What Sponsors Must Know About Digital Systems And AI Compliance

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by Jessica Cordes  - July 17, 2025

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Guest Column | July17, 2025

What Sponsors Must Know About Digital Systems And AI Compliance

By Jessica Cordes, senior consultant, Clinical Excellence GmbH

A close-up of a laptop keyboard with a person working in a dimly lit environment. Digital overlay icons appear above the keyboard, including a document with checkmarks and lines symbolizing data or text, suggesting digital compliance, regulations, or document management.

In July 2025, the European Commission initiated a public consultation on proposed changes to three critical components of Good Manufacturing Practice (GMP) guidance: Chapter 4 (Documentation), Annex 11 (Computerised Systems), and a brand-new Annex 22 covering the use of artificial intelligence (AI).

Please read the full Clinical Leader Article.

About the Author

Jessica Cordes

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Jessica Cordes is Managing Director of Clinical Excellence GmbH. She has 15+ years in clinical operations and previously served as Head of Clinical Operations at Immatics Biotechnologies and Medigene Immunotherapies, leading first-in-human cell & gene therapy trials.

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