All case studiesPharma

GxP-Compliant MLOps Platform for Clinical Trial Analytics

Delivered a validated, audit-ready model deployment pipeline meeting FDA 21 CFR Part 11 requirements — in 16 weeks.

⏱ 16 weeks👥 4 engineers + 1 GxP consultant

Results

FDA 21 CFR Part 11 compliant — passed inspection with zero findings

Full audit trail with e-signatures on every model promotion

5× faster model deployment (12 days → 2.4 days average)

100% rollback coverage — any version restorable in under 10 minutes

Platform adopted by 3 additional internal teams post-launch

The challenge

A mid-size CRO (Contract Research Organisation) was running clinical trial analytics models in ad-hoc Jupyter notebooks, with no versioning, no audit trail, and no validated deployment process. Their FDA submissions were at risk if auditors found model changes without proper documentation. They needed a fully validated MLOps platform before an upcoming FDA inspection.

Our approach

1
Engaged a GxP compliance consultant alongside our engineering team from week 1.
2
Built a model registry on MLflow with mandatory e-signature workflows using 21 CFR Part 11-compliant audit logging.
3
Implemented immutable pipeline runs — every training job is hashed, stored, and linked to a model version.
4
Automated IQ/OQ/PQ (Installation/Operational/Performance Qualification) test suites run on every deployment.
5
Deployed on a private AWS GovCloud environment with end-to-end encryption and role-based access control.

Tech stack:KubernetesMLflowTerraformPythonAWS GovCloud

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