WORK / PHARMACEUTICAL / LIFE SCIENCES
Regulated-Lab Audit Intelligence
Eli Lilly: Mapped the FDA-regulated data flow and deployed a reasoning-model pipeline that clusters logs, flags out-of-spec events and explains root cause in plain English. It runs against the existing laboratory systems under strict controls.
Metric: >$2M/year operational savings. Timeframe: 8-week deployment.
We mapped the complete FDA-regulated data flow and built an AI pipeline that automatically clusters logs by statistical significance, flags out-of-spec events in real-time, and generates plain-English root-cause explanations. The system integrates with existing LIMS and ERP systems under strict validation controls, maintaining complete audit trails for regulatory compliance.