Insight Brief · Backup & Restore

Backup and restore testing:
evidence inspectors expect.

In regulated environments, ‘we have backups’ is not evidence. Inspectors look for proof that restores work, that scope is appropriate, and that the organisation can recover critical records when it matters.

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A Proportionate Approach

Restore testing that
is risk-based.

Adopt a risk-based approach that covers regulated records, configuration and critical supporting components, without creating disproportionate testing overhead.

01
Define scopeInclude regulated records, system configuration, interfaces and critical supporting components. Justify scope with reference to risk and intended use.
02
Justify frequencySet testing frequency based on criticality and change volume. Document the rationale: more frequent testing is expected for critical, high-change systems.
03
Test methodologyInclude targeted partial restores alongside periodic full restore scenarios where justified. Each type of test addresses different risk objectives.
04
Capture evidenceTest steps, outcomes, deviations and approvals, retained and retrievable for inspection, not just recorded internally in a ticket system.
Evidence Pack

What to have ready
for an inspection.

These items form the core of a defensible backup and restore evidence set for GxP systems including those hosted by SaaS vendors.

01
Backup strategy documentAligned to record impact and criticality. Covers scope, frequency, retention and responsibility boundaries with suppliers or cloud providers.
02
Restore test reportsTest steps, outcomes (pass/fail), deviations identified and approvals. Including date, scope and system state at the time of each test.
03
Deviation and CAPA linkageWhere restore tests identify issues, these must flow into the formal deviation and CAPA process with clear ownership and resolution evidence.
04
Supplier evidence (SaaS)For cloud-hosted systems, evidence must include supplier backup and restore controls, not just an assertion that the supplier manages this.
Common Questions

Frequently asked.

How often should we test restores?
As often as risk justifies, with documented rationale
Critical systems often require more frequent testing. The key is documented rationale and repeatable evidence, not a fixed calendar frequency applied uniformly across all systems.
Does SaaS remove the need for restore testing?
No, it changes the evidence
You need to understand the supplier’s backup and restore controls, obtain relevant evidence, and maintain governance that demonstrates ongoing oversight of the supplier’s capability.
What is the most common mistake?
Never testing until an incident occurs
Organisations that cannot demonstrate recovery capability under scrutiny face significant inspection risk. A restore that has never been tested is not evidence of recoverability.

Backup evidence gaps?
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