Closed-loop complaint handling driven by statutory vigilance deadlines
Manage market complaints, incident triage, and authority reports under FDA 21 CFR 820.35, ISO 10002, and EU MDR Art 87. Real-time regulatory countdown clocks and direct bridge to CAPA.
Complaints & Vigilance Management
Illustrative interface rendering. Real screens and recordings live on the module pages.
Complaints & Vigilance Management
Who it is for: Vigilance specialists, medical directors, QA complaint managers, regulatory affairs leads
Regulatory Vigilance Clocks
Active countdown timers and SLA escalations for FDA eMDR (5/30 days), EU MDR MIR forms, and competent authority notifications.
Risk-based triage and batch linking
Instant prioritization for patient safety and product quality, tied to batch genealogy and immediate root-cause investigation.
Integrated action loop
One-click initiation of CAPA, Change Control, batch quarantine, or Field Safety Corrective Action (FSCA / Recall).
Trend and adverse signal detection
Identifies recurring failure modes and adverse event spikes with statistical control charts.