TrakPath · Compliance detailsDSCSA
Drug Supply Chain Security Act
Lot-level traceability, transaction history, and serialization records produced automatically from each scan event — ready for FDA inspection and trading-partner exchange.
TrakPath · Compliance details
Regulator-grade chain-of-custody, by default.
TrakPath turns every label into a compliance event. DSCSA, USP <797>/<800>, and 503A/B traceability are produced as a side-effect of how your team already works — scan, hand off, ship.
Legacy vs TrakPath
Speed of compliance truth
Source hydration
5m+ paper log
15s QR scan
Custodial anchoring
10m+ manual entry
3s auto-ledger
CoA verification
15m+ email lookup
5s auto-attach
Audit reconstruction
4h+ forensics
2s ledger replay
Frameworks TrakPath satisfies
Every scan event maps directly onto the artifacts regulators ask for.
USP <797> / <800>
Sterile & hazardous compounding
Captures BUD, environmental conditions, and handling chain so 503A and outsourcing facilities meet USP chapter requirements without paper logs.
503A / 503B
Patient-specific & outsourcing trace
503A patient-specific dispenses tie back to the prescriber and patient. 503B serialized lots roll up to outsourcing facility production batches with full chain visibility.
HIPAA · SOC 2
PHI-safe custody data
Custody events are stored without PHI by default. When PHI is required (patient-specific 503A), it's encrypted at rest, access-logged, and SOC 2-aligned.
The controls behind the ledger
Smartphone-only hardware. Immutable ledger. Audit-ready out of the box.
Single-tap hydration
Any worker scans the QR or barcode already on the label. GPS, timestamp, and photo anchor in under fifteen seconds — no proprietary hardware.
Geo-anchored custody events
Each scan time-stamps and geo-anchors the handoff. Jurisdictional rules switch automatically when shipments cross state or national lines.
Offline-ready sync
Captures events in dead zones and remote facilities. The immutable ledger hydrates the moment connectivity returns — no event ever lost.
Cold-chain sentinel
BLE temperature loggers stream into the same ledger. Excursions raise alerts and tag affected units for quarantine before they ship.
Inventory reconciliation
Live unit counts mapped to lots, bins, and expirations. Discrepancies surface as compliance findings instead of end-of-month surprises.
Audit reconstruction in seconds
Pull the full custody graph for any unit, lot, or patient shipment in two seconds. Legacy paper-and-spreadsheet reconstruction takes four-plus hours.
Audit replay, not audit reconstruction
Pull a unit, lot, or patient shipment, and TrakPath replays the full custody graph — every scan, actor, location, temperature, and CoA attachment — in the order it happened. What used to be a four-hour forensic exercise becomes a two-second link an inspector can open from your laptop.
Hydration
15s
Anchoring
3s
CoA verify
5s
Audit replay
2s
Make compliance a side-effect of operations.
Connect TrakPath to your labels, your team, and your trading partners — and stop reconstructing what you should have been recording.