ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems

Publication Date: 2010

See also:


Keeping a safe copy of information (usually done on a regular basis) so that in can be recovered in the event of loss due to human error, hardware or software failure, data corruption, theft, sabotage, or natural disaster. Backup copies need to be stored and maintained with the same degree of care as live data, as this is what the data becomes when it is restored from the backup copy.

Backup copies are often employed for short-term recovery with an archive used for long-term storage. However, an electronic archive also should have a backup. Another distinction between backup and archive is that the backup will contain copies of master records, whereas the archive is deemed to contain the master records.

Publication Source: GAMP® Good Practice Guide: Electronic Data Archiving

Publication Date: 2007


The process by which electronic data and document stores are regularly copied and retained for the purpose of restoration following a problem. Back-up copies are generally retained for a short term.

Publication Source: GAMP® Good Practice Guide: Global Information Systems Control and Compliance

Publication Date: 2005

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