U.S. Drug Supply Chain Security Act (DSCSA)

A complete set of capabilities for achieving and maintaining compliance with U.S. Drug Supply Chain Security Act regulations.

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:

• Confidently meet U.S. DSCSA traceability requirements
• Streamline regional compliance operations and processes
• Insulate internal enterprise systems from regional compliance demands

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.

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.

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.

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.

How TraceLink DSCSA Compliance drives efficiency

• Integrate Once, Interoperate with Everyone™
• Increase scalability
• Ensure compliance
• Minimize supply disruption