Glossary
Exception Report
A report that uses validated search rules to find predefined abnormal data or actions and present them to the reviewer.
Source · MHRA GxP Data Integrity Guidance (2018), §6.13 Audit trail
Details
Exception reports allow risk events to be selected efficiently from large audit trails, but they must be validated so that events outside the rule are not automatically excluded. Inspections cite weak justification for the search conditions and thresholds, unverified completeness and sensitivity, and missing version control and reconciliation against the source audit trail. Look at the requirements and verification evidence, the rules and their versions, generation logs, review and investigation, and periodic performance assessment.
Related sections
Related terms
Source
MHRA GxP Data Integrity Guidance (2018), §6.13 Audit trailGRM Regulatory Glossary
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