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Pharmaceutical Manufacturers, Repackagers, Wholesale Distributors, and Dispensers use US Compliance to meet the interoperable, electronic tracing requirements for serialized products established by the US Drug Supply Chain Security Act (DSCSA). For outbound shipments, US Compliance receives the shipment details from Serialized Operations Manager, parses the NDCs and lot numbers of the products that require traceability, and generates the transaction information and transaction statement documents (often referred to as the T2 documents) for each NDC and lot number combination. US Compliance then sends the shipment details on to the company purchasing the product. For inbound receipts, US Compliance receives the receipt details from the company selling the product, parses the NDCs and lot numbers of the products that require traceability, generates the T2 documents for each NDC and lot number combination, and creates a corresponding receipt in Serialized Operations Manager.
The T2 documents allow Owners to provide the traceable documents per the DSCSA to auditors. The shipment and receipt information is available through US Compliance for troubleshooting purposes and to provide the original document where the product was recorded with the full aggregation hierarchy.
US Compliance Owners also link to their downstream or upstream supply chain trade partners to send and receive the delivery information passed from Serialized Operations Manager while maintaining the data integrity and security of their serialized system of record. Owners can also choose to send certain shipments to Product Information Manager, so that indirect trade partners or direct trade partners who aren't linked to their US Compliance network can access the details for those receipts.
