Disaster Recovery
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Disaster recovery is the documented, tested capability to restore a GxP computerized system and its data to a known-good state after a failure, corruption, or catastrophic event. It is the operational safety net that ensures records and system function survive incidents without loss of data integrity.
A disaster recovery plan defines recovery objectives, backup frequency, restore procedures, and roles; critically, the restore must be periodically tested, because an untested backup is only a hope. Regulators specifically expect evidence that data can actually be recovered, not merely that backups are taken.
Disaster recovery is distinct from long-term archiving: it restores operational continuity, whereas archiving preserves records for their retention period. A robust operation needs both, and both must be validated as fit for purpose.
- —Restores system and data to a known-good state after failure.
- —Restore must be periodically tested, not just configured.
- —Defines recovery objectives, roles, and procedures.
- —Distinct from long-term archiving.
EU GMP Annex 11 §7.2 (backups) and §16 (business continuity); GAMP 5 Second Edition (2022) operational controls.
Frequently asked questions
What is Disaster Recovery?
Disaster recovery is the documented, tested capability to restore a GxP computerized system and its data to a known-good state after a failure, corruption, or catastrophic event. It is the operational safety net that ensures records and system function survive incidents without loss of data integrity.
Which regulations cover Disaster Recovery?
EU GMP Annex 11 §7.2 (backups) and §16 (business continuity); GAMP 5 Second Edition (2022) operational controls.