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 validation framework
A validation approach for AI-enabled GxP applications, from intended use to monitoring.
Challenge
Traditional CSV templates did not address model performance, drift or training data.
Requirement
A framework that extends existing CSV practice to AI components.
Approach
Add AI-specific deliverables — data assessment, model assessment, acceptance criteria, monitoring plan — to the existing validation lifecycle.
Process & execution
- 1Intended use
- 2Risk
- 3Data assessment
- 4Model assessment
- 5Test & acceptance
- 6Monitoring
- 7Change control
Technology / process
- GAMP 5
- CSA
- Model performance metrics
Documentation
- Validation plan template
- Model assessment template
- Monitoring plan template
Verification
Framework applied to a pilot AI tool and reviewed against inspection questions.
Outcome / expected benefit
Expected benefit: AI tools validated consistently and proportionately.
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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Automation / Quality
PLC / HMI / SCADA design & verification
Specifying and verifying the control system of a new filling machine before GMP use.
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Digital / Manufacturing / Software
Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
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