Glossary

Back-up

A copy of current, editable data together with its metadata and system configuration, kept so that recovery is possible after a disaster or failure.

Source · PIC/S PI 041-1 (2021), §13 Glossary: Back-up

Details

A backup exists for operational recovery and does not take the place of an archive kept for regulatory retention. Inspections cite copies that took the data but omitted metadata, audit trails, and configuration, and success logs relied on with no restoration test. Check the backup scope and frequency, off site storage, automatic logs, periodic restoration testing, and investigation of failures.

Related sections

PIC/S PI 041-1 §9.8 EU GMP Annex 11 §7.2

Related terms

Archiving / Archive1 caseDisaster RecoveryBusiness Continuity

Real inspection findings

See 2 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

PIC/S PI 041-1 (2021), §13 Glossary: Back-up

GRM Regulatory Glossary

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