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Product overview
Comply with U.S. DSCSA requirements
TraceLink U.S. DSCSA Compliance provides secure, electronic data exchange via EPCIS, verification services compliant with the VRS industry standard, and collaboration tools for resolving DSCSA-related exceptions with trading partners. The DSCSA Compliance solution provides the fastest time to compliance, lowest cost of ownership, and the best compliance visibility and management.
With TraceLink DSCSA Compliance, you can:
Industry challenges
DSCSA compliance requires a host of new capabilities
Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving DSCSA requirements. These challenges include:
Supply partner integration
DSCSA requires the onboarding, integration, and ongoing maintenance of hundreds to thousands of trade partners for secure, electronic, interoperable exchange of EPCIS transactions.
Supply partner integration
Invasive changes to enterprise systems
Companies must make their operations "serialization aware," which requires invasive changes to warehouse management systems (WMSs) and enterprise resource planning (ERP) systems.
Invasive changes to enterprise systems
Massive amounts of data to process
The DSCSA demands a highly scalable architecture that is capable of processing massive amounts of item-level serialization data at operational scale without disruption or downtime.
Massive amounts of data to process
Platform maintenance without downtime
Companies need ways to push updates as regulatory, standards and business requirements evolve up to and after the DSCSA deadline without disrupting supply chain processes.
Platform maintenance without downtime
See more challenges
Ongoing maintenance of integrations to support the evolution of regulations, standards and business requirements up to and after regulatory deadlines.
Product verification for salable returns, suspect and illegitimate product investigations.
Managing and maintaining aggregation hierarchies throughout warehouse and distribution operations.
A highly scalable architecture is required to process massive amounts of item-level traceability data at an operational scale without disrupting or delaying business processes.
Rapidly resolve DSCSA-related exceptions that will require real-time collaboration and troubleshooting with trade partners.
Capabilities
TraceLink DSCSA Compliance
With the TraceLink “Integrate Once, Interoperate with Everyone™” network model, organizations can exchange transactions with all partners through a single integration to the TraceLink network.
Wholesale Distributor Summit SD Relies on TraceLink for DSCSA Compliance
Industry voices
Building a stronger network
Hear what our customers and partners are saying about TraceLink DSCSA Compliance.
Hear what our customers and partners are saying about TraceLink’s U.S. DSCSA solution.
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Use Cases
DSCSA Compliance across the supply chain
See how TraceLink DSCSA Compliance keeps everyone in the supply chain—from manufacturers to wholesalers to retail pharmacies and health systems—compliant with the requirements.
See how TraceLink's U.S. DSCSA solution has grown business for our customers.