For life sciences organisations, system failure is not just downtime. It is lost research, delayed submissions, and regulatory exposure. GxP-Cloud DRaaS provides a qualified, monitored, and annually tested recovery framework so that when something goes wrong, your response is as compliant as your operations.
Standard disaster recovery restores systems. GxP disaster recovery restores systems in a qualified, documented, and compliant manner. The distinction matters significantly when an EMA or MHRA inspector asks how your systems were recovered following an incident and whether the recovery process preserved data integrity.
GxP-Cloud DRaaS was designed specifically for this requirement. Every backup is encrypted and validated. Every recovery environment is pre-qualified. Every restoration activity is logged, reviewed, and maintained in our Quality System. When something fails, your recovery is as defensible as your operations.
Under Annex 11 and 21 CFR Part 11, restored data must be complete, attributable, and unaltered. Standard DR does not address this. GxP DRaaS does.
A system recovered into an unqualified environment is not in a compliant state. GxP-Cloud recovery environments are pre-qualified and reserved for your use.
Regulators expect evidence that your DR plan works and that it has been tested. Annual DR testing with documented results is a regulatory expectation, not optional.
Any change to your backup configuration, recovery environment, or DR plan is a change control event. GxP-Cloud manages this under formal QA oversight.
Every layer of GxP-Cloud DRaaS is designed with GxP, data integrity, and audit readiness as first-order requirements — not features added on top of a standard backup product.
Encrypted, validated backups replicated to separate geographic and network zones. Data protection and compliance with data sovereignty requirements built in. Backups are encrypted, transferred, and stored on separate networks and media from production systems.
Compute and storage resources pre-allocated and verified for immediate activation during failover. Your recovery environment is not shared, not provisioned on demand, and not subject to capacity constraints when you need it most.
Backup and replication jobs are verified daily by Validated Cloud engineers. Any failure is identified and acted upon immediately. Integrity checks ensure your backup is what you think it is — before you need it.
Comprehensive qualification records to support your own validation and audit activities. Every backup configuration, every recovery environment, and every test result is documented and maintained within our Quality System.
Annual disaster recovery testing verifies performance and qualification under real-world scenarios. Results are documented, reviewed by our QA team, and available to support your inspection readiness activities.
Supports small research environments through to enterprise-scale commercial operations. From Phase 2 through post-market, a single DRaaS framework that scales with your organisation and your regulatory obligations.
DRaaS is most effective when designed alongside your primary infrastructure. Our EU team can assess your current DR posture and outline what qualified recovery looks like for your environment.
Book a consultationChoose in-region or cross-region storage to meet data residency, latency, and regulatory requirements. EU data stays in the EU unless you instruct otherwise.
Backups are encrypted, transferred, and stored on separate networks and media from production systems. Isolation is structural, not configured.
All backup and restore activities are logged, reviewed, and maintained within our Quality System. Every restoration has a complete audit trail.
Pre-qualified recovery environments with reserved compute capacity ensure rapid failover and minimal downtime. Recovery is not improvised. It is pre-planned and pre-qualified.
Our DRaaS qualification documentation is designed to support your own validation and audit activities directly — not to require additional work on your end to use.
Speak to our EU teamGxP-Cloud conducts annual disaster recovery testing that verifies performance and qualification under real-world scenarios. The test results are documented, reviewed by our independent QA team, and made available to support your regulatory activities and inspection preparation.
Testing is not a box-tick exercise. It validates that your recovery time objectives are achievable, that data integrity is preserved through the recovery process, and that all documented procedures work as designed. Any gaps identified during testing are managed through formal change control and remediated before the test cycle closes.
A documented test plan is developed under QA oversight, defining objectives, scope, success criteria, and the specific scenarios to be tested.
The DR test is executed by Validated Cloud engineers against defined scenarios. All activities are logged in real time throughout the test.
Test results are reviewed by our independent QA team against defined success criteria. A formal test report is produced and maintained in our Quality System.
Any deviations identified during testing are managed through formal change control and remediated before the annual cycle is closed.
Test plans, results, and remediation records are available to support your own audit activities and inspection preparation at any time.
Business continuity and disaster recovery are specific inspection topics under EMA Annex 11. Inspectors expect documented DR plans, evidence of testing, and proof that recovery procedures preserve data integrity. The organisations that answer these questions confidently all made the same decision: they treated DR as a compliance requirement, not an IT afterthought.
Our DR framework is designed to be inspection-ready at all times — not assembled when an audit is announced. The documentation, testing records, and qualification evidence are maintained continuously and available to you on request.
EMA Annex 11 and MHRA guidance are built into our DRaaS framework from the ground up. EU data centres in Amsterdam and Dublin provide geographic separation within the EU. Cross-region replication to US facilities available for transatlantic requirements.
Book a 30-minute consultation with our EU team. We will assess your current DR posture, identify your GxP recovery gaps, and outline what qualified disaster recovery looks like for your specific environment and regulatory obligations.