Starting point
On the spectrophotometer, data manipulation at operating system level was possible. The audit trail was incomplete and no backup concept existed for local data.
Proprietary data formats could only be read with vendor software; a long-term readability process and infrastructure for virtual machines were missing. For data integrity all gaps had to be closed in one project.
Approach
cube one closed technical and process gaps in lab IT and equipment qualification in a short project timeline.
Integrity on the instrument PC
- Kiosk mode configured; prevents manipulation at operating system level.
- PowerShell script developed and implemented for audit trail capture of specific functions.
- Backup concept created and implemented.
Long-term readability and archiving
- Process for readability of proprietary data established, including SOPs.
- Vendor software virtualised; infrastructure for VM storage provided.
- Data archived; readability secured for retention.
Related: data readability and system virtualisation.
Result
Data integrity on the instrument
- System meets data integrity requirements.
- Audit trail complete and compliant.
- Data protected from loss; system successfully qualified.
Long-term readability
- Data archived; long-term readability secured.
- Standardised process established for future projects.
- Infrastructure for storing virtual machines established.
Related: NanoDrop One.