Starting point
Without a defined decommissioning procedure, exports are stored without a defined process, integrity evidence is missing and restore capability was never validated.
Inspections then produce findings whose remediation exceeds archiving itself. The client needed a tamper-evident archive with demonstrated recoverability for the full retention period.
Approach
cube one structured the system landscape before shutdown and implemented archiving plus recovery concept under GxP requirements.
Inventory analysis and archiving
- Complete identification and documentation of relevant data sets, dependencies and interfaces.
- Consolidated full backups with defined completeness and consistency checks.
- Implemented concept for retention periods, archive formats and target systems.
Integrity evidence (SHA-256 via STREAM where migration required).
Restore test and validation
- Built validated test environment for access after system shutdown.
- Verification and restore tests: data integrity, readability and system independence demonstrated.
- Recoverability evidence for audit and inspection scenarios documented.
Additionally: system virtualisation and data integrity consulting.
Outcome
Tamper-evident archive
- Tamper-evident archiving system for the full statutory retention period.
- Increased data security and resilience of laboratory systems.
- Transparent, always demonstrable compliance evidence.
Demonstrated recoverability
- Demonstrated recoverability in failure scenarios.
- System hardware is decommissioned; electronic archive remains inspection-ready.
- Not an unchecked ZIP, but an archive with validated recovery path.
Related: data readability and system virtualisation.