We establish governance frameworks that ensure AI systems are used in a controlled and compliant manner across GxP-regulated activities, aligned with expectations from authorities such as the EMA, MHRA and FDA.
Assess the impact of AI on product quality, patient safety, and data integrity, with risk-based classification aligned to GxP criticality.
Support for defining validation approaches for AI systems, including intended use, model behaviour, data inputs, and performance monitoring ensuring systems are inspection-ready.
Ensure AI outputs meet ALCOA+ principles and that systems maintain traceability, explainability, and audit trails suitable for regulatory inspection.
Advisory on the compliant use of AI across clinical and patient-facing applications, quality management systems, manufacturing and process monitoring, as well as pharmacovigilance and safety reporting.
Evaluate AI vendors and tools used within GxP processes to ensure appropriate controls, transparency, and compliance alignment.