Glossary

Periodic Evaluation

Periodic assessment of whether a computerised system remains validated and compliant with GMP.

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 evaluation