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DSCSA 2023 Preparation Continues to Accelerate with VRS R1.3 Network Ecosystem Upgrade

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TraceLink collaborates with the industry to roll out important enhancements to the verification router service (VRS) network ecosystem to help pharma supply chain industry participants prepare for Drug Supply Chain Security Act (DSCSA) 2023 requirements and deadlines.

On Monday, July 10th, the pharma industry’s VRS working group announced the completion of a significant upgrade to the industry’s interoperable verification network created several years ago to support the DSCSA product identifier verification requirements. Launched early in 2023, the R1.3 upgrade initiative was designed to promote enhancements to the foundational VRS solution network capabilities in support of the expanded capabilities documented in the previously published GS1 US Lightweight Messaging Standard for DSCSA Verification Implementation Guideline R1.3.

A significant part of the upgrade was to ensure extensive interoperability testing among the VRS solution provider participants. TraceLink was one of the founding members of the VRS task force and committed early on to a full and robust VRS solution to support not only full request, response, and lookup directory capabilities, but also an extensible solution that could evolve as use cases such as those in R1.3 were developed. TraceLink has been a committed leader since then in helping drive standardization, scalability, and operational readiness of VRS capabilities to support the industry.

Driven by extensive industry feedback received over the past several years of usage of the VRS network by pharmaceutical companies, wholesale distributors, and other supply chain participants, important new features were tested and deployed in this upgrade following a multi-month preparation period. These capabilities include:

  • Expanded data model and transaction capabilities to enable verifications for new use cases of suspect or illegitimate product investigation, exception processing, and product status checking
  • New contact data fields (email address, phone number), to be provided by requesters and responders, to facilitate questions and resolution of issues arising from verification requests
  • Support for verification of a product identifier that has an extended expiration date beyond that which was originally set for the product when it was initially introduced into the supply chain
  • Support for possession or control attestations provided by the requester
  • Support for business rule setting message priority for product identifiers which may have multiple application status conditions when a verification is requested

Significant planning preparation and operational testing went into the latest upgrade to ensure that supply chain participants can confidently leverage VRS solutions for DSCSA compliance and business purposes. Fifty-four test cases were developed to exercise VRS solutions, leveraging existing test cases and augmenting them with new test conditions designed to exercise the new VRS enhancements. Based on these test cases, solution providers collaborated on executing over 2,500 individual tests to check individual solution capabilities as well as interoperability between VRS solutions in the lead-up to this past weekend’s production cutover. Following this upgrade, solution providers are collaborating on a series of performance-tuning activities to further harden the network for November 2023 DSCSA deadlines.

TraceLink has been at the forefront not only in helping lead the development and interoperability testing of the VRS network but also in its adoption and production usage. TraceLink’s Product Information Manager - Product Verification solution provides unsurpassed capabilities for companies seeking the ability to scan products and submit product identifiers for verification, or to respond to verification inquiries received from across the supply chain. Used in conjunction with our Supply Chain Work Management (now POET), TraceLink also provides integrated capabilities to manage and resolve issues and exceptions which may occur during verification processes. Today, TraceLink verification solutions are used by almost 400 companies to help them meet DSCSA compliance requirements, protect patient safety, and improve supply chain operations. TraceLink manages over 60% of the product GTINs in the U.S. VRS network, with a significant portion of the over 41 billion serialized products managed by the TraceLink network available for verification through its Product Information Manager - Product Verification solution.

As companies continue to ramp up their DSCSA 2023 preparations, we are ready to immediately provide product verification capabilities for your business and your network. We look forward to having a conversation with your unique DSCSA needs.

 

BlogUS Drug Supply Chain Security ActDSCSA for Dispensers, DSCSA for ManufacturersUnited States

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