Transform How Complaints and Adverse Events Are Handled

1. Multichannel Complaint Intake

Complaints don't arrive in neat, structured packages. They come as free-text emails, phone call transcripts, web form submissions, field service reports, customer portal entries, and partner submissions. Smarteeva captures them all- from every channel, in every format, and brings them into a single complaint management system. Our AI reads unstructured complaint narratives and auto-extracts key data fields: product information, complaint type, date of event, patient involvement, device identifiers, lot numbers, and more. Records are auto-populated, duplicates are detected, and foreign-language complaints are translated -all before your team even opens the record. Your team stops doing data entry and starts doing quality work.

2. AI-Driven Classification & Risk Assessment

Not every complaint is urgent. But without intelligent triage, every complaint gets the same level of attention, which means the ones that actually matter don't get attention fast enough. Smarteeva's automated decision trees assess every incoming complaint in real time. Severity is determined based on product history, complaint type, patient involvement, potential health impact, and historical patterns. A risk score is assigned. High-risk complaints are flagged and escalated immediately. Routine complaints are classified and routed automatically based on your configurable business rules. Every classification shows the factors that drove the AI's decision, so your team can validate or override with full transparency.

3. Machine Learning-Guided Investigation

When an investigation is required, Smarteeva's machine learning engine provides intelligent starting points. The system surfaces similar past complaints and their investigation outcomes, suggests root cause hypotheses based on historical patterns, recommends assessment questions relevant to the complaint type, and auto-populates investigation forms with data already captured at intake. Your investigators spend their time analyzing root causes and making quality decisions, not searching for comparable cases and rebuilding context from scratch.

4. Customer & Partner Self-Service

Smarteeva provides self-service portals that allow your customers and distribution partners to submit complaints directly, in a structured format that feeds straight into your complaint management system. This eliminates the back-and-forth of email-based complaint collection, ensures you capture complete information at the point of submission, and gives customers visibility into the status of their complaints.

5. Real-Time Validation & Smart Audit Trail

Every action in Smarteeva is validated in real time, required fields are enforced, data consistency is checked, and workflow steps are tracked automatically. The smart audit trail captures every change, every decision, and every AI-assisted action with full traceability. When it's time for an audit - FDA, EU Notified Body, or internal, your complaint records tell a complete, defensible story from intake to closure.

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