Glossary
Business Continuity
Arrangements that keep essential GMP processes running by suitable alternative means during a failure of a critical computerised system.
Source · EudraLex Volume 4, Annex 11 (2011), §16 Business Continuity
Details
Business continuity keeps critical activities such as batch processing, testing, and storage safe and traceable even before the system is restored. Inspections cite manual fallback procedures with no trigger criteria, responsibilities, data re-entry, or reconciliation method defined, and fallback arrangements that were never exercised. Check the criticality risk assessment, the fallback procedures, the contact and authority structure, exercise records, and the data reconciliation and review carried out once normal operation resumes.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 11 (2011), §16 Business ContinuityGRM Regulatory Glossary
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