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
PLC / HMI / SCADA design & verification
Specifying and verifying the control system of a new filling machine before GMP use.
Challenge
The vendor’s standard documentation did not cover user access, audit trail or data retention needs.
Requirement
A control system that meets process and data-integrity requirements, with documented verification.
Approach
Write a URS with data-integrity requirements, review the functional design, and plan risk-based FAT/SAT and qualification.
Process & execution
- 1URS
- 2Design review
- 3Risk assessment
- 4FAT
- 5SAT
- 6IQ/OQ
- 7Traceability & report
Technology / process
- PLC
- HMI
- SCADA historian
- GAMP 5
Documentation
- URS
- FS/DS review
- FAT/SAT protocols
- IQ/OQ protocols
- Traceability matrix
Verification
Every URS requirement traced to a passed test or documented rationale.
Outcome / expected benefit
Expected benefit: equipment that enters GMP use with compliant records from day one.
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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Software / Quality / Digital
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Illustrative use caseQuality / Digital / Software
eQMS workflow digitisation
Moving deviation, CAPA and change control from paper forms to linked electronic workflows.
Illustrative use case