Starting point
An analytical laboratory needed a complete equipment qualification for NanoDrop One measurements in a GxP environment at short notice. Qualification documents, risk assessments and test execution had to be coordinated.
Several PCR instruments were also pending regulatory release. Without a validation manager role, gaps between documentation, test cases and the review process are likely.
Approach
cube one took the validation manager role in full and led the entire qualification process for NanoDrop One and PCR instruments.
NanoDrop One qualification
- All qualification documents created and reviewed (VAPR, validation determination, user requirements, audit trail risk assessment, compliance assessment).
- Entire qualification process led and coordinated.
- Four-month project timeline from planning to release.
Equipment qualification and CSV for software evidence.
PCR instrument qualification
- Qualification engineer and validation manager roles performed.
- Documentation fully created and owned.
- Test cases executed and review process steered.
Outcome
NanoDrop One
- Instrument available for planned GxP measurements.
- Complete qualification finished in just four months.
- Audit-ready qualification file complete.
PCR instruments
- Multiple PCR instruments successfully qualified and regulatorily released.
- Clear role separation between qualification engineer and validation manager.
- Review process documented and closed.
Related: production equipment and spectrophotometer lab IT.