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Global Compliance

United States

Comply with US DSCSA requirements for both lot and item level identification and traceability. TraceLink’s Integrate Once, Interoperate with Everyone™ architecture enables rapid onboarding and integration with suppliers and customers for the receipt and shipping of US DSCSA transactions. Support for the EPCIS transformation event is used to link the original item serial number to that of the repackaged one. Facilitate managing serialization data at the edge of warehouse processes such as receiving, sampling, pick, pack, ship, and re-work.

Benefits

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

  • Rapid trade partner onboarding. Use a network model to eliminate the need for point to point connections with trade partners.

  • Repackaged Item Traceability. Associate original item serial numbers to the item serial numbers representing repackaged product.

  • Broad use case support. Use case support for both pure repackagers as well as repackagers with additional use cases including contract packaging, wholesaling, and dispensing.

Applications

Product Track
Product Track provides repackagers 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 original item serial numbers and the serial numbers for the repackaged product are linked through the EPCIS standard transformation event. 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 repackagers with the 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 repackagers 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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