Quality Control
Automated QC, dual-agent validation, human approval, and follow-up management
Cross-field Validation & Consistency Checks
9/10 PassFieldCheck TypeResultStatus
Patient DemographicsCompletenessPass
Product InformationCross-field consistencyPass
Event DescriptionMedDRA alignmentPass
Date ConsistencyTemporal logicPass
Reporter InformationCompletenessPass
Seriousness CriteriaCoding consistencyPass
Causality AssessmentAlgorithm matchWarning
Narrative vs FieldsText-data alignmentPass
Regulatory FieldsRegion-specific completenessPass
E2B(R3) SchemaStructural validationPass
Anomaly Detection
Causality Assessment
Reporter causality 'Possible' — algorithm suggests 'Probable' based on temporal relationship and absence of alternative causes
