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Articles on AI in the GxP environment.

Our articles explain regulatory requirements and examine the use of AI in GMP, MedTech and QA processes.

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Teal data streams connect transparent source and processing modules on a deep-navy background.

Articles · AI in GxP environments

AI in the GMP environment: What the Annex 22 conference means for practice

AI can make knowledge more accessible, prepare analyses and support quality decisions. Our visit to the Annex 22 conference in Copenhagen highlighted the prerequisites: a clear intended use, suitable data, risk-based validation and demonstrably effective controls. Drawing on practical examples and one example developed throughout the article, we explain how companies can assess AI applications in the GMP environment and keep them under control in operation.

17 October 2026Read article

Data layers and connected information illustrating data quality and data governance in GxP environments.

Articles · AI in GxP environments

Data Quality and Data Governance for AI in GxP Environments

How data quality, data governance and data qualification support the fitness of data for AI applications in GxP environments.

20 October 2026

Prioritisation of 30 QA tasks by process performance (P) and quality, integrity and safety impact (QIS).

Articles · AI in GxP environments

AI in QA Processes: Which Applications Are Suitable Starting Points?

Which QA tasks suit AI? A matrix of 30 applications compares process benefits and quality impact, with three practical starting points.

20 October 2026

Articles · AI in GxP environments

AI in GMP and MedTech Companies: Which Regulations Apply and When Is Validation Required?

Which requirements apply to AI in GMP and MedTech companies? How intended and actual use determine the regulatory assessment and when validation is required.

19 October 2026