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
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Challenge
SOPs were circulated by e-mail and shared drives, with no reliable view of the current version.
Requirement
One source of truth for controlled documents with Part 11-compliant signatures.
Approach
Model the document lifecycle, roles and signature meanings, then build and validate the workflow.
Process & execution
- 1Draft
- 2Review
- 3Approval
- 4Effective
- 5Revision
- 6Archive
Technology / process
- Workflow engine
- Electronic signatures
- Audit trail
- Role-based access
Documentation
- URS
- Functional specification
- Test scripts
- Validation report
- Admin SOP
Verification
Lifecycle, signature and audit-trail functions tested against requirements.
Outcome / expected benefit
Expected benefit: staff always use the current effective version.
This is an illustrative use case describing a typical project structure. It does not describe a specific client, product or completed engagement.
More use cases
Automation / Quality
PLC / HMI / SCADA design & verification
Specifying and verifying the control system of a new filling machine before GMP use.
Illustrative use case
Digital / Manufacturing / Software
Electronic batch record concept
Designing the move from paper batch records to electronic execution with review by exception.
Illustrative use case