Glossary
Disaster Recovery
The plan and procedures for restoring systems or data to an agreed state from backups after a failure or disaster.
Source · MHRA GxP Data Integrity Guidance (2018), §6.17.2 Backup; EudraLex Annex 11 §16
Details
Disaster recovery has to demonstrate not that a backup exists but that data and configuration can actually be restored to a defined point within a defined time. Inspections cite restoration testing never performed, key metadata and audit trails omitted, failed tests not investigated, and procedures that do not match the real environment. Look at the recovery plan, the basis for the RPO and RTO, the backup scope, periodic restoration tests and their results, and CAPA.
Related sections
Related terms
Source
MHRA GxP Data Integrity Guidance (2018), §6.17.2 Backup; EudraLex Annex 11 §16GRM Regulatory Glossary
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