Documents needed for each type of work
Pick a work type to see the required documents stage by stage. Click any document to open its record, or generate drafts with the AI agent.
Workload type
AI-ML focus
Model or GenAI build: training data, model performance, drift, explainability and human oversight.
- Data provenance, labelling and training/test split
- Model metrics, acceptance thresholds and drift monitoring
- Explainability, bias review and human-in-the-loop controls
- AI-specific GxP impact and intended use statement
- 1
Initiate
2 documentsRegister the system and confirm the governing policy applies.
- 2
Define
2 documentsCapture business requirements and the agreed functional scope.
- 3
Design
2 documentsSolution architecture and the detailed technical build design.
- 4
Assess & test
4 documentsCriticality assessment, model card and the testing route (GxP or non-GxP).
- 5
Go live
2 documentsCutover, deployment and access provisioning.
- 6
Operate
3 documentsRun, review periodically and plan eventual retirement.