AUSTIN, TX – March 7, 2022 – XATP and Spherity today announced interoperability between their digital wallet services in support of regulatory compliance with the U.S. Drug Supply Chain Security Act (DSCSA) by fall 2023. This key milestone enables trading partners using either platform to securely exchange and verify each other’s credentials as Authorized Trading Partners (ATPs).
A critical DSCSA requirement is the assurance that regulated interactions happen exclusively between ATPs: properly registered manufacturers, repackagers, wholesalers, third-party logistics providers (3PLs), and dispensers. More than 60,000 U.S. pharmaceutical supply chain participants are legally required to achieve regulatory compliance by November 2023. Both XATP and Spherity offer electronic solutions that deliver on the FDA guidance to respond to data requests in under one minute.
“The DSCSA mandates electronic interoperability across the entire U.S. pharmaceutical supply chain, and decentralized credentials have emerged as the only realistic path to achieving regulatory compliance,” said XATP president Ben Taylor. “With decentralized credentials, each ATP’s identity is in their own hands. We are excited to work alongside Spherity to enable real-time interoperability for ATPs in a zero-trust world.”
“Spherity is thrilled to be working alongside XATP to deliver the world’s first truly interoperable exchange between credentialing platforms for DSCSA compliance,” said Georg Jürgens, Manager Industry Solutions at Spherity. “Trading partners can acquire user-friendly digital wallets and ATP credentials to engage in DSCSA-regulated interactions.”
As members of the Open Credentialing Initiative (OCI), XATP and Spherity both support the use of W3C-specified Decentralized Identifiers (DIDs) and Verifiable Credentials (VCs), GS1 messaging standards and data attributes, and open standards to achieve safe and secure credentialing and information exchange between ATPs.
“The clock is ticking on DSCSA compliance, and identity lies at the heart of every interaction between trading partners,” said OCI facilitator Bob Celeste. “Today’s announcement is a key moment for verifiable credentials in the pharmaceutical industry, as we all work together to further secure the U.S. drug supply.”
XATP and Spherity have both launched programs for ATPs and solution providers to obtain and test credentials for ATP authentication. Learn more at the XATP and CARO by Spherity websites, or contact email@example.com and firstname.lastname@example.org. You can also join us on March 8, 2022 at the HDA Distribution Management Conference and Expo in Austin, TX, where Ben Taylor and Georg Jürgens will be discussing credentialing at the Traceability Roundtables series.
Members of both early access programs will be provided the opportunity to participate in OCI interoperability workshops and shape the future of DSCSA compliance. For more news and invitations to future OCI events, subscribe to the OCI newsletter.
Dr. Christiane Wirrig
XATP is a non-profit member services organization created to enable ATP authentication, enhanced verification, and saleable returns documentation. XATP members include global enterprises, health centers, and independent pharmacists committed to assuring prescription drugs remain safe and effective for patients. XATP is powered by LedgerDomain, a solutions provider focused on healthcare supply chain assurance and visibility.
Spherity is a German software provider bringing secure and decentralized identity management solutions to enterprises, machines, products, data and even algorithms. Spherity provides the enabling technology to digitalize and automate compliance processes in highly regulated sectors. Spherity’s products empower cyber security, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.