TracePharma
Features / Compliance

Feature deep dive

Compliance reporting & governance

Inspection-ready artifacts generated from live operational data. Whether you ship serialized product, receive-to-ship as a wholesaler, or verify at dispense, compliance exports pull from the same event history operators use daily.

FDA Form 3911

  • Prefill suspected illegitimate product reports from verification exceptions—so 3911 drafts start from operational data, not blank forms.
  • Capture notifier, product, and incident details in-app—so staff complete reports without re-keying verify context.
  • Export PDF draft for FDA CDER NextGen 3911 submission—so compliance packages include a submission-ready artifact.

Verification summaries

  • Period-based statistics: attempts, successes, failures, and rates.
  • Filament report page for management and compliance review.
  • Included in compliance package exports.

Partner license validation

  • Scheduled license checks on trading partners.
  • Manual review driver or MedPro API integration.
  • License status visible on partner records.

Operations scorecards

  • Manufacturer and wholesaler scorecards with ACK health and blocked-reason trends.
  • 3PL principal-scoped operations view for multi-brand warehouses.
  • Dispenser scorecard with PMS blocked-reason trends for pharmacy profiles.

Operational awareness

  • Drug shortage notices from central feed on tenant dashboard.
  • Onboarding PM checklist for platform admins at go-live.
  • Compliance package bundles verification and exception evidence.

See compliance exports live

Request a demo—we'll generate a sample verification summary and 3911 draft from a test exception.

Request a demo