SECTOR HH • PHARMACEUTICAL SUPPLY CHAIN SECURITY
DSCSA Pharmaceutical Track & Trace Serialization
Achieve full compliance with FDA Drug Supply Chain Security Act mandates: GS1 EPCIS 1.2 electronic data exchange, 2D DataMatrix scanning, ATP verification, and instant quarantine holds.
End-to-End Package-Level Traceability for Pharma Motor Carriers
The FDA DSCSA has transformed pharmaceutical freight from bulk pallet manifests into unit-level electronic verification. Carriers and 3PLs must demonstrate secure data exchange, credentialed trading partner verification, and instantaneous quarantine workflows on suspected suspect product.
Electronic exchange of Transaction Information (TI) and Transaction Statements (TS).
Simultaneous verification of NDC, unique serial identifier, batch lot, and expiration.
Automatic system lockouts preventing cross-dock staging or delivery of unverified serials.
Interactive DSCSA Serialization & Quarantine Audit Simulator
Simulate inbound cross-dock scanning, test ATP credential verification, and audit suspect drug investigation readiness.
DSCSA Audit & Cross-Dock Clearance Status
Authorized Trading Partner (ATP) Status: VERIFIED • LICENSED
Package Serialization Clearance: 100% Cleared for Domestic Linehaul
Electronic Quarantine Flag: 0 Pallets Quarantined (All Clear)
FDA Form 3911 Illegitimate Product Risk: Zero Risk Detected
Recommended Action: RELEASE CROSS-DOCK DOORS FOR OUTBOUND DISPATCH
Under FDA rules, any mismatched serial must be quarantined within 24 hours and reported via FDA Form 3911 if determined illegitimate.
How EXSPEEDITE Automates DSCSA Operations
1. Direct GS1 EPCIS Data Ingestion
EXSPEEDITE connects via REST and AS2 APIs to major pharmaceutical track-and-trace repositories (TraceLink, SAP ATTP, rfxcel), ingesting serial manifests before trucks hit the dock.
2. Barcode OCR Verification
Terminal cross-dock handlers utilize rugged Zebra scanners or iOS devices running the EXSPEEDITE app. Scans match unit serials in real time against manifest databases.
3. Automated T3 Document Archiving
Transaction records (TI, TH, TS) are cryptographically stored for the federally mandated 6-year retention period, searchable in seconds during FDA or state board of pharmacy audits.
Achieve Total DSCSA Compliance with EXSPEEDITE
Schedule a 1-on-1 demonstration with our pharmaceutical track-and-trace technology architects. See how EXSPEEDITE secures compliant life sciences distribution.