Starting point
In a regulated laboratory, historic viability measurements were stored on a cell-viability analyser whose physical hardware was due for removal. Raw data did not sit as exported files but in a proprietary database structure, protected by differential and incremental backups. Without the native vendor software, neither the visual display nor the evaluation of measurements could be reproduced.
For QA and data integrity, this is a typical decommissioning risk: the record exists formally but is no longer legible in the ALCOA+ sense. An inspection can then no longer verify whether calibration data, audit trails and timestamps still match the original measurement context. The client therefore needed two independent readability paths: via the original software and via future-proof standard formats.
Approach
cube one delivered the project in two interlocking tracks. Both address the same regulatory question: do historic raw data stay readable, faithful to the original and traceable for the full statutory archiving period?
Backup reconstruction and virtual machine
- Reconstruction of the differential and incremental database backups of the cell-viability analyser and conversion into a format the original software can read directly.
- Provision of a dedicated VM including native vendor software so display and evaluation of raw data permanently match the original system behaviour.
- Development and documentation of a reproducible process: who may access the VM, how data is read, how errors are handled. Access via change control, not ad-hoc approvals.
- Creation of evidence for traceability of the recovery process in line with data-integrity requirements. Related: system virtualisation and data archiving.
Automated conversion to open long-term formats
In addition to the VM path, we automatically and in a validated manner transferred proprietary raw data from the vendor software into standardised, open formats. The goal was independence from obsolete software architecture without metadata loss.
- Validated transfer of raw data into formats that can be read system-independently without dedicated vendor software.
- Complete and immutable transfer of metadata, timestamps and processing steps (audit trail) into the target formats.
- Access controls on the converted data set to prevent unauthorised changes or deletions.
Framework and assessment: Data Integrity consulting and IT administration.
Outcome
Readability via original software
- Historic raw data from the cell-viability analyser remain retrievable in an audit-safe manner for the long term without the original physical hardware being active.
- Readability is fully decoupled from ageing physical hardware. Retention is a defined operating process, not an unstructured folder on a network share.
- By using the original software in the VM, no metadata is lost. Results stay fully interpretable, including audit trails, calibration data and timestamps.
Readability via standard formats
- Data stay readable for the full statutory archiving period even if vendor software can no longer be operated.
- Open standard formats allow immediate, system-independent access for internal reviews and inspections.
- Migration into future-proof formats reduces the risk of data corruption through obsolete software architectures to a minimum.
Both paths complement each other: the VM secures faithful interpretation, conversion secures long-term independence. Related case stories: system virtualisation and data archiving.