OCI Closes U.S. DSCSA Compliance Gap with an Industry-First
February 1, 2022 - OCI invites pharmaceutical supply chain actors into its Early Adopter Program to trial the industry’s first compliance solution for U.S. DSCSA Authorized Trading Partner authentication.
The U.S. Drug Supply Chain Security Act (DSCSA) mandates that an interoperable electronic system to protect the integrity of the pharmaceutical supply chain be fully operational by November 2023. One critical, yet thus far neglected, requirement is the assurance that interactions happen exclusively between authorized trading partners (ATP), i.e. properly registered entities.
The launch of the Open Credentialing Initiative (OCI)’s Early Adopter Program now makes the industry’s first functional, scalable solution widely available enabling U.S. supply chain actors to become DSCSA-compliant well ahead of the deadline.
Robert Celeste, OCI Facilitator and Founder of the Center for Supply Chain Studies said, “Leveraging W3C standard verifiable credentials, OCI members have developed a technological architecture facilitating automated real-time ATP status checks between trading partners involved in saleable returns.
“The solution has been tested with industry partners. Stakeholder involvement is important for us to incubate not only practical novel software solutions but also to set reasonable technical conformance criteria within this ecosystem. These are key roles of OCI.
“The solution is ready. What is needed now is a push for timely industry-wide adoption. The clock is ticking!”
Born out of an industry-wide pilot, OCI has been crucial in standardizing the credentialing architecture. The result is currently the only functionally available, practical solution mature enough to meet the 2023 deadline.
Thanks to fully API-based integration of Verification Routing Service providers, Trading Partners have no technical implementation effort. Hence, ATP authentication can be incorporated into existing processes without disruption.
The Early Adopter Program now allows supply chain companies to test the technology for free.
Georg Jürgens, Manager Industry Solutions at Spherity, said, “Developing our tech stack further within the OCI framework has been an incredible journey. After an initial focus on manufacturers and wholesalers, we are now looking into adapting the solution to dispensers. We look forward to seeing the OCI ecosystem grow.”
Within less than a year OCI has grown from a pilot project to a credible body that has been supported by major industry players, such as SAP, Tracelink, HDA, Novartis as well as standards organizations such as GS1. With more than 60,000 active trading partners involved in the U.S. Life Sciences Industry there is still much work to be done.
About OCI
The Open Credentialing Initiative (OCI) is a collaborative non-profit industry collaboration formed in April 2021 by a group of trading partners, solution providers, and standards organizations to support the pharmaceutical industry in adopting credentialing and digital wallet technologies to enhance supply chain security, and thus the protection of consumers.
The ecosystem is open to Trading Partners, Solution Providers, Associations, Standards Bodies and others interested in contributing to future enhancements of the architecture and use cases.
