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
eQMS workflow digitisation
Moving deviation, CAPA and change control from paper forms to linked electronic workflows.
Challenge
Overdue CAPAs were found late, and links between deviations and changes were lost.
Requirement
Linked records, due-date tracking and management metrics.
Approach
Harmonise the three procedures, define shared data fields and link rules, then configure and validate.
Process & execution
- 1Procedure harmonisation
- 2Data model
- 3Workflow configuration
- 4Migration
- 5Validation
- 6Go-live
Technology / process
- eQMS
- Dashboards
- Notifications
Documentation
- Revised SOPs
- Configuration specification
- Migration plan
- Validation report
Verification
End-to-end scenarios executed from deviation through CAPA to effectiveness check.
Outcome / expected benefit
Expected benefit: overdue actions visible early and complete quality histories.
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