Context

A global development organisation with 25 active trials seeking to implement AI for automated query resolution and anomaly detection while maintaining regulatory compliance.

Challenge

Teams needed operational AI benefits to reduce manual data review burden while maintaining inspection-ready controls. Initial implementations raised concerns about 21 CFR Part 11 compliance and audit trail requirements.

Approach

Designed a governance framework covering model validation, data quality controls, auditable decision logging, and human-in-the-loop workflows. Implemented AI with full audit trails and version control across all models.