UC-419
Complaint Intake and Reportability Clock
Reads each complaint as it lands, drafts device and event coding, and puts a reportability recommendation to the regulatory reviewer.
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The Challenge
Reportability clocks start the day a complaint arrives and a missed decision becomes an inspection finding. Complaints reach the file through service tickets, distributors and clinicians in free text.
How It Works
- Reads complaint intake forms, field service tickets, distributor reports and device records.
- Codes device and health effect terms, links repeats to the same lot and scores reportability.
- Gives the regulatory reviewer a drafted rationale, the clock and the evidence per case.
What It Removes
- Manual coding of complaint free text to term codes
- Spreadsheet tracking of reportability decision clocks
- Re-reading service notes to confirm device involvement
Input Data RequirementsComplaint intake records, field service tickets, distributor and clinician reports, device master records, lot and UDI data, prior vigilance decisions
Output FormatCoded complaint file with drafted reportability rationale, decision clock dashboard, lot and model trend view for the quality board
“The clock starts when the complaint lands, not when someone gets round to coding it three weeks later”