AUSTIN, TX – March 7, 2022 – Today at the HDA Distribution Management Conference, LedgerDomain announced the launch of its Early Access Program for credentialing and compliance with the Drug Supply Chain Security Act (DSCSA). Participating manufacturers, repackagers, third-party logistics providers, wholesalers and dispensers now have access to a full suite of products that establish secure channels and support compliance across the broader Authorized Trading Partner (ATP) community. Anchored in OCI-compliant interoperable verifiable credentials, Interoperable XATP Credentials and KYATP Relationship Manager with SigBlock give ATPs the tools needed to face today’s interoperability requirements.
Under the DSCSA, pharmaceutical supply chain stakeholders have a recurring obligation to confirm the authorized status of their direct trading partners, and to initiate as well as respond to enhanced product verification and tracing requests. FDA’s draft guidance has set the bar for verification response times at less than one minute. Moreover, ATP status confirmations and responses should be documented and archived to demonstrate compliance, with many stakeholders envisioning archiving obligations stretching to a dozen years.
“There are four questions facing every authorized trading partner today,” said Ben Taylor, CEO of LedgerDomain. “How will you manage your own credentials to best match up with 120,000+ ATPs? How will you authenticate the status of counterparties? How can you ensure auditability for these checks? And how can you work more effectively with your partners while protecting against bad actors?”
To address this demand, LedgerDomain has unveiled two new products that work together to help achieve DSCSA compliance:
Interoperable XATP Credentials are the first step to meeting compliance and engaging with the greater ATP community. Any ATP may apply online, get accredited by a third-party accreditor, and receive a secure digital wallet and physical key. Enterprises can hold a bundle of ATP credentials to better serve the needs of their business units and franchises, even down to the NDC level, level, and in turn delegate signing authority to work streams.
KYATP Relationship Manager with SigBlock is the next-generation “know your ATP” relationship manager that uses verifiable ATP credentials as an anchor point to securely manage confidential information, unlocking new levels of service and security. Now ATPs can navigate the complex landscape of direct and indirect trading partners and demonstrate their ongoing DSCSA compliance efforts regardless of the channel used. For example, if partners use their AS2 channel to share EPCIS files that are then used for tracing, KYATP can map the linkages amongst those channels back to the ATP’s verifiable credentials. SigBlock is the KYATP logging module that immutably captures every signing of the credential, creating a secure time-stamped archive ensuring compliance through to the time of audit.
“We’ve demonstrated how our XATP iPhone app enables a single pharmacist to tackle DSCSA compliance, and our enterprise partners are asking us to help them support many complex work streams,” said Alex Colgan, Head of Strategic Partnerships at LedgerDomain. “Our extended ATP credentialing through XATP combines with our KYATP suite to capture every signature and time-stamp it for as long as their policies dictate.”
XATP achieves DSCSA-mandated interoperability as a member of the Open Credentialing Initiative (OCI), and supports 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. Verifiable XATP credentials are fully interoperable with any OCI-compliant credential and LedgerDomain’s KYATP Relationship Manager logs every interaction with any OCI-compliant credential.
Learn more and sign up for the XATP and KYATP Early Access Programs at xatp.org/membership, email firstname.lastname@example.org, or request a briefing this week at the HDA Distribution Management Conference and Expo in Austin, TX.
XATP is a non-profit member services organization providing Authorized Trading Partners and other eligible members, such as regulators, with Verifiable ATP Credentials. XATP’s credentials are OCI-compliant and powered by LedgerDomain, which provides additional value-added services to pharmaceutical supply chain stakeholders. XATP is a member of the Partnership for DSCSA Governance (PDG), GS1, and OCI.
LedgerDomain is a Las Vegas-based web3 solutions provider focused on extending healthcare supply chain assurance and visibility to all stakeholders. LedgerDomain’s mission is to help stakeholders deliver life-saving therapies to patients at the right time, every time. LedgerDomain is a member of the Healthcare Distribution Alliance (HDA).