AI quality and CAPA audit on a regulated health-tech platform, delivered into production in one quarter.
- Time to production
- 1 quarter
- Manual review time
- Materially reduced
- Audit posture
- Preserved
What we shipped
myQMS, a Miami health-tech company, needed to add AI to a quality management product serving regulated US customers. The goal was to take repetitive work off quality managers, including CAPA review and audit preparation, without weakening the audit trail the product is built around.
Quality management customers operate under ISO-aligned processes. They will not adopt AI that sits outside the audit trail, and they need answers they can defend to regulators. MyQMS needed AI that would speed up the work without introducing new risk.
Blueprint → AI Pilot → Production launch → Scale and operate.
We followed the Datablooz Delivery Model. See our process.
- Blueprint
One-week working session to identify the highest-ROI workflows. We prioritized two use cases where AI could save meaningful time without weakening the compliance posture.
- AI Pilot
Three-week prototype on real MyQMS data. We validated the model performance and proved the audit trail could carry every AI-driven action.
- MVP in production
Shipped the integrated feature to pilot customers inside 10 weeks, with monitoring and a documented operating manual.
- Scale and operate
Ongoing reliability engineering and model governance review. Retraining cadence is documented, and every model change goes through a review.
Business, technical, and governance outcomes.
- Two AI-backed workflows live in the MyQMS product.
- Full audit trail preserved for every AI-driven action.
- Governance model aligned with ISO quality management expectations.
- Operating review rhythm established between MyQMS and Datablooz.
- Python
- PyTorch
- FastAPI
- PostgreSQL
- Cloud-agnostic deployment
Model cards maintained per feature. Every AI action is logged with input, output, and the responsible human reviewer. Drift monitoring is checked monthly.
Working on something similar?
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Reference calls available under NDA after the second working session.