Pharmaceutical Giant Achieves EU AI Act Readiness with Comprehensive Governance Framework

A global pharmaceutical company with operations across 80 countries was deploying AI extensively in drug discovery, clinical trial optimization, manufacturing quality control, and commercial operations. However, governance was fragmented—each business unit managed AI independently with inconsistent standards.

The EU AI Act created urgency. Several AI systems, including clinical trial patient selection and manufacturing quality prediction, fell into high-risk categories requiring extensive compliance documentation, risk management systems, and conformity assessments.

ELMET conducted a comprehensive AI inventory, identifying and classifying 53 AI systems across the enterprise. Risk assessments were performed against EU AI Act criteria, revealing 12 high-risk systems, 28 limited-risk systems, and 13 minimal-risk applications.

An enterprise AI governance framework was designed with three pillars: organizational structures (AI ethics board, Centers of Excellence, roles and responsibilities), policies and standards (development standards, deployment criteria, monitoring requirements), and technology platforms (model registry, guardrails platform, monitoring dashboards).

The AI ethics board was established with representation from R&D, Commercial, Manufacturing, Legal, Compliance, IT, and external advisors. Clear charter and operating procedures enabled efficient review without creating bottlenecks.

A multi-model governance platform was deployed to provide unified oversight. The platform implemented consistent guardrails across all AI systems, automated compliance documentation, and provided real-time monitoring of model performance and fairness metrics. Within six months, all 53 AI systems were brought under governance with full EU AI Act documentation.