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.
Compliance case management
- ✓ Open and track compliance cases linked to serials, partners, and events.
- ✓ Assignment, status, and resolution notes for regulatory follow-up.
- ✓ Case evidence bundled into compliance package exports.
TI/TS compliance dashboard
- ✓ Transaction information and statement coverage across inbound and outbound.
- ✓ Gap trends per trading partner for proactive supplier outreach.
- ✓ Profile-tuned views for manufacturer, wholesaler, and 3PL compliance leads.
Tracing requests & SLA
- ✓ Log and track DSCSA tracing requests with response deadlines.
- ✓ SLA dashboard for open, overdue, and completed tracing cases.
- ✓ Linked serial history and partner context for faster investigation.
Recall management
- ✓ Recall case workflows with affected serial and lot scope.
- ✓ Recall broadcasts to trading partners with delivery tracking.
- ✓ Investigation views tied to inbound and outbound event history.
Analytics workspace
- ✓ Self-serve compliance and operations analytics beyond fixed scorecards.
- ✓ Export-ready views for management review and inspection prep.
- ✓ Profile-gated metrics for manufacturer, wholesaler, 3PL, and dispenser tenants.
Compliance notification rules
- ✓ Configurable alerts for verification failures, stale ACKs, and license lapses.
- ✓ Route notifications to compliance leads and integration contacts.
- ✓ Reduce surprise findings during audits with proactive awareness.
Explore other capabilities
See compliance exports live
Request a demo—we'll generate a sample verification summary and 3911 draft from a test exception.