Laboratory / Quality
Contract laboratory testing programme
Setting up release and stability testing at a contract laboratory for a new product.
Illustrative use caseIllustrative use case
AI quality risk assessment
Classifying proposed AI use cases by risk and defining the validation each one needs.
Challenge
Several departments wanted AI tools, with no consistent way to judge risk.
Requirement
A repeatable intake and risk classification for AI use cases.
Approach
Define risk factors (GxP impact, autonomy, data sensitivity, explainability), a scoring method and validation expectations per class.
Process & execution
- 1Use-case intake
- 2Risk factors
- 3Scoring
- 4Classification
- 5Validation expectations
- 6Approval
Technology / process
- ICH Q9(R1)
- GAMP AI guidance
- Risk matrices
Documentation
- Intake form
- Risk assessment template
- Classification procedure
Verification
Framework trialled on existing use cases and reviewed by quality leadership.
Outcome / expected benefit
Expected benefit: consistent, documented decisions on AI adoption.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
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