Pharmaceutical serialisation — the unique identifier printed on every prescription medicine pack — has been mandated in the US and EU for several years. The DSCSA (Drug Supply Chain Security Act) and EU Falsified Medicines Directive require that every product unit can be traced through the supply chain. But serialisation data alone — a barcode scan timestamp at a warehouse — doesn't tell regulators where that product was in between scans. GoAndTrack provides the physical location layer that bridges serialisation events with continuous GPS tracking, creating the unified audit trail that enforcement bodies expect.
The Regulatory Framework: DSCSA and EU FMD
US DSCSA
The Drug Supply Chain Security Act mandates product identification (serial number, lot number, expiry date) on every prescription drug package at unit level. Requires transaction history exchange between trading partners and the capability to verify, trace, and investigate suspect or illegitimate products. FDA enforcement now active — wholesalers and 3PLs must provide end-to-end product tracking records on request.
EU FMD / Delegated Regulation 2016/161
The Falsified Medicines Directive requires a unique identifier (2D DataMatrix barcode) and tamper-evident seal on all prescription medicines sold in the EU. Authentication at dispensing point against European Medicines Verification System (EMVS). Logistics partners handling serialised products must maintain chain of custody records consistent with the serialisation audit trail.
The gap that both regulations reveal: serialisation systems record when a product was scanned at a defined point (manufacturer, wholesaler, 3PL, pharmacy). They do not record where the product was between those scan events — which is the majority of the product's transit time. A temperature excursion or cold chain breach discovered at a pharmacy could have occurred at any point in the preceding 48-hour journey, but the serialisation record cannot identify where. GoAndTrack's GPS tracking layer fills this gap.
The Serialisation + GPS Audit Trail Architecture
Unified Pharmaceutical Audit Trail: From Manufacturer to Pharmacy
Manufacturer Release
Serialised unit (GTIN + serial number) logged in serialisation system. Temperature record initiated. GoAndTrack shipment created with lot number reference linking GPS tracking to serialisation record.
In-Transit (GoAndTrack Active)
Tive Solo Pro or Reelables sensor attached to shipment. GPS position, temperature, humidity, and shock recorded continuously. GoAndTrack Mission Control monitors against GDP thresholds. Any excursion: timestamped, geolocated, escalated.
Wholesaler Receipt
Product scanned into serialisation system. GoAndTrack journey record linked by timestamp and lot number. Wholesaler receives GoAndTrack temperature certificate alongside DSCSA transaction statement — one PDF covering both compliance requirements.
Final Mile to Pharmacy
Last-mile delivery vehicle (GPS-tracked by GoAndTrack) carries serialised product. Delivery event logged by GoAndTrack geofence entry at pharmacy location, timestamped and linked to lot number. Pharmacy scan against EMVS confirms authentication.
Investigation Response
If a suspect product is identified at pharmacy, GoAndTrack's full journey record — GPS positions every 60 seconds, temperature readings every 5 minutes, handler transition events — is exportable as a timestamped audit trail. Covers the physical location gap in the serialisation record.
AI Queries for Pharmaceutical Serialisation Compliance
Devices for Pharmaceutical Serialisation-Linked Tracking
| Device | GDP Validated | DSCSA-Ready Report | Serial No. Linkage | GoAndTrack Integration |
|---|---|---|---|---|
| Tive Solo Pro | ✓ Pharma validated | ✓ Auto-generated | ✓ Via shipment record | ✓ Live API |
| Reelables 5G | GDP-compatible | ✓ Via GoAndTrack | ✓ Via shipment record | ✓ Live API |
| OnAsset Argo | ✓ Aviation + pharma | ✓ Auto-generated | ✓ Via shipment record | ✓ API |
| Frigga (download) | Temperature only | Manual import to GoAndTrack | Via CSV linkage | CSV import |
| Sensolus (facility) | Environmental only | Facility record only | ✓ Via facility event | ✓ Live API |
Key Takeaways
- DSCSA and EU FMD serialisation records capture scan events at defined points — GoAndTrack provides the continuous GPS and environmental record between those events, filling the physical location gap that serialisation alone cannot answer
- DSCSA suspect product investigations require traceability data within two business days — GoAndTrack's exportable journey record (GPS + temperature + handler events) is the physical layer evidence that complements the transaction history
- Lot number linking at shipment creation connects the serialisation world to the GoAndTrack tracking world — a DSCSA investigation query by lot number returns the complete physical tracking record instantly
- Tive Solo Pro (GDP validated), Reelables 5G, and OnAsset Argo all connect to GoAndTrack and generate DSCSA-ready combined temperature and location reports automatically — eliminating the manual assembly that typically takes hours per investigation
- The multi-provider architecture is specifically valuable for pharmaceutical logistics: Tive for in-transit cold chain, Sensolus for facility environmental monitoring, GoAndTrack GPS on vehicles — all linked by lot number to create a single audit trail across the full product journey
Complete the Pharmaceutical Audit Trail
Serialisation tells you when. GoAndTrack tells you where — continuously, throughout the journey. DSCSA-ready reports, GDP temperature certificates, and lot-number-linked tracking in one platform.
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