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Global Compliance

United States

Comply with US DSCSA requirements for both lot and item level identification and traceability. Purpose-built application that integrates with your operations rather than disrupting them. TraceLink’s Integrate Once, Interoperate with Everyone™ architecture eliminates the need for custom data maps to support trade partner requirements. Facilitate managing serialization data at the edge of warehouse processes such as receiving, sampling, pick, pack, ship. and re-work. Provide verification service to enable saleable returns verification for wholesalers.

Benefits

  • Lot and item level tracking. Manage transaction histories, information, and statements for product at the item and lot level.

  • Standards support. Support for lot level EDI Advanced Shipment Notice and EPCIS transactions for serialized product.

  • Trade partner on-boarding. Meet trade partner requirements for integration including initial set up and ongoing support.

  • Broad use case support. Use case support for all segments included in a single application.

Applications

Product Track
Product Track provides pharmaceutical manufacturers with the functionality to generate and manage transaction information, history, and statements in compliance with the Drug Supply Chain Security Act (DSCSA). At the point of shipment, DSCSA compliant EDI 856 ASN for lot level and the EPCIS for serialized product messages are generated and delivered in the format required by the wholesaler, pharmacy, or health system. Product Track ensures that the transactions include the required compliance data. Product can also be verified at the lot or item level to support suspect product investigations. Transactions are archived for 12 years, but readily searchable through a variety of search parameters including product code, lot number, and supplier.

Edge Track
Edge Track provides manufacturers with functionality to manage serialization throughout warehouse processes. Edge Track facilitates the data capture of serialization data through mobile devices and communicates to the appropriate business systems — ERP, WMS and serialization repository.

Product Information Manager
Product Information Manager provides verification functionality that pharmaceutical manufacturers can use to enable saleable returns verification for their wholesaler customers. The solution enables rapid individual and batch verification of serial numbers in a secure controlled environment so that pharmaceutical manufacturers do not have to expose their internal serial number repository to third parties.

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