Glossary
Periodic Evaluation
Periodic assessment of whether a computerised system remains validated and compliant with GMP.
Source · EudraLex Volume 4, Annex 11 (2011), §11 Periodic evaluation
Details
Periodic evaluation judges the continued fitness of a system by taking together its functionality, deviations, incidents, upgrades, performance, reliability, security, and validation status. Inspections cite the use of a calendar checklist alone, and failure to assess accumulated changes, recurring incidents, access rights, and backup and recovery results. Look at the evaluation plan and report, changes, deviations, and incidents, performance and security, privileges, and validation status.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 11 (2011), §11 Periodic evaluationGRM Regulatory Glossary
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