Situation
A multi-tenant eQMS release changes dashboard colors, the CAPA-routing engine, and the signature block used in exported approved records.
Intended Use
Users create, investigate, route, approve, sign, retain, retrieve, and export controlled CAPA records. The dashboard supports prioritization; the workflow and signed export preserve required approval meaning.
Failure Scenarios
The color change could make status harder to distinguish. The routing change could bypass Quality approval for a legacy blank site value. The export change could omit signature meaning or associate the signature with the wrong revision.
Existing Controls and Evidence
The supplier provides release notes, known defects, automated regression results for the standard platform, and rollback information. The customer maintains a configuration inventory, local workflow specification, representative open records, monitoring, and prior protocol results.
Testing Approach
Perform an accessibility and usability confirmation for the dashboard rather than broad regression. Script each material CAPA routing branch, unauthorized transitions, open-record state, and legacy data condition. Script signer identity, meaning, time, record association, revision, accurate copy, and export retrieval. Explore interruption and concurrent-review paths around the critical controls.
Deviations and Validation Conclusion
The dashboard check passes. The fictional blank site value bypasses routing and the first export omits signature meaning. Release is restricted until both are corrected and targeted retest passes. One release does not require one uniform regression scope.
Reassessment Criteria
Reassess shared-service changes, new workflow configuration, identity or signature changes, supplier incidents, monitoring signals, or undocumented behavior.