Because a validated system is only as good as its last restorable backup.
Backup and recovery systems sit squarely inside GxP scope. If your batch records, chromatography data, or audit trails cannot be restored intact and on demand, the data integrity of everything built on top of them is in question — and an inspector will ask you to prove otherwise.
Valitech designs, implements, and qualifies backup and restoration for regulated environments, so that recovery is a documented, tested procedure rather than an assumption.
What we deliver
- Backup strategy and retention design mapped to GxP record-retention obligations
- Implementation of scheduled, monitored, and alerted backup jobs
- Documented restoration testing — proving that a restore actually works, not just that a backup ran
- Disaster recovery and business continuity procedures
- Backup and restoration SOPs, with defined roles and escalation paths
- Qualification documentation and periodic review of the backup system itself
Why it draws observations
Backup is one of the most commonly cited weak points in data integrity findings. The usual gaps are not exotic: backups that were never restore-tested, retention that does not match the record's required lifetime, no audit trail over the backup job, or no SOP describing who restores what and when. Each is straightforward to close once it has been documented properly.
Backup and recovery is one of the twelve system types we treat as in-scope for Computerized System Validation. We qualify it to the same standard as the applications it protects.