Validated quality model in production (GxP)

The brief

In pharma, a model that affects quality decisions must be validated and controlled like any GxP system. Build the batch-quality model, then deploy it with version control, an audit trail of every prediction, change records and a validation report. Good looks like: a validation plan and report, a deployed model with audit logs, a controlled change process, and monitoring.

What you will build

1. Build and evaluate the quality model
2. Write a validation plan with acceptance criteria
3. Deploy with versioned models and an audit trail
4. Run a controlled change: a new model version with records
5. Monitor performance and drift
6. Write the validation report

Free, open data to build it with

• Pharmaceutical manufacturing process and quality data ↗ Scientific Data (Nature)

Check each dataset's licence before you publish your work. Your mentor gives your team its own version of the brief (data, scope or region), so every team's project is its own.