Capture every event. Resolve every complaint.
From deviations on the production floor to customer complaints in the field, QFacts gives your quality team a single system to capture, investigate, and resolve events with full traceability.
Complete event management
Every capability your quality team needs to handle deviations, complaints, and non-conformances, from initial capture to trend analysis.
Real-Time Capture
Log deviations, complaints, and non-conformances the moment they occur. Mobile-friendly forms ensure nothing slips through the cracks on the production floor.
Smart Classification
Categorize events by type, severity, product line, and root cause using configurable taxonomies that match your quality system.
Root Cause Analysis
Built-in investigation tools guide your team through structured root cause analysis, from fishbone diagrams to 5 Whys, so corrective actions address the real problem.
Trend Reporting
Spot recurring issues before they escalate. Automated trend analysis across event types, product lines, and time periods drives proactive quality improvement.
Escalation Rules
Define automatic escalation paths based on event severity or aging. Critical events reach the right decision-makers immediately, without manual routing.
Regulatory Reporting
Generate FDA MDR, EU Vigilance, and customer complaint reports directly from event data. Reduce reporting preparation time from days to minutes.
Five stages from capture to closure
A structured workflow that ensures every event is properly investigated, classified, and resolved, with a complete audit trail.
Capture
Log the event with structured data fields, attachments, and initial classification.
Investigate
Assign investigators, gather evidence, and perform root cause analysis.
Classify
Determine event type, severity level, and regulatory reporting obligations.
Resolve
Implement corrective actions, verify effectiveness, and close the event with approval.
Report
Generate trend reports and regulatory submissions from consolidated event data.
Root cause investigation
When an event has impact, QFacts automatically triggers an investigation. Classify severity, perform root cause analysis, link CAPAs, and track resolution, all in a single connected workflow with full audit trail.
Built for your role
See how different team members use QFacts Events & Complaints every day.
See how Quality Officer uses Events & Complaints to log a production deviation with photos and initial classification in under two minutes, then track the investigation through to root cause and corrective action.
See how Production Lead uses Events & Complaints to report a customer complaint directly from the shop floor, attach supporting evidence, and receive automatic updates as the quality team investigates and resolves the issue.