Smarteeva Decision Tree

Summary

‍Smarteeva Decision Tree: Standardized Reportability Decisions

Smarteeva’s Decision Tree guides quality teams through reportability assessment based on product type and incident country. The system adapts to FDA, EU MDR, Health Canada, TGA, and 80+ other regulatory frameworks. Every step is recorded, creating a standardized audit trail. Machine learning models learn from historical decisions to improve speed and consistency over time.

When a decision tree determines a complaint is reportable, the system automatically routes it to the adverse event module. No manual handoff. No re-entry of data. The complaint record, decision path, and all supporting data carry through.

What You Will Learn

How region-specific decision logic adapts to each jurisdiction’s regulatory framework. How step-by-step recording creates a complete audit trail for every reportability assessment. How machine learning enhances accuracy by learning from historical decisions. How Smart Guy extends decision tree functionality to customer-facing portals, mobile apps, and connected devices.

Key Capabilities

Multi-country assessment: one complaint evaluated against multiple jurisdictions simultaneously. Auto-routing: reportable events flow directly to adverse event processing without manual intervention. Predictive insights: ML surfaces complaints likely to be reportable before manual review begins. Self-service: customers and field teams can initiate assessments directly through the portal.

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