Drug Manufacturers Facing DSCSA Requirements Can Now Interoperate with the Entire Pharma Supply Chain on their Own Terms
October 18, 2023, Las Vegas – LedgerDomain, a leader in decentralized technologies for healthcare, announces the public launch of the XATP Magic Portal for manufacturers seeking DSCSA compliance. In a collaborative effort, the portal solution was designed in consultation with key domain leaders at leading pharmaceutical companies and includes contributions from credentialing expert Legisym and the Movilitas.Cloud platform. The Magic Portal is the easiest way to adopt industry-standard workflows so that manufacturers can become DSCSA-compliant within a week.
Starting on November 27, 2023, Authorized Trading Partners (ATPs) in the U.S. pharmaceutical supply chain have one year to implement, troubleshoot, and mature their electronic interoperable systems under the Drug Supply Chain Security Act (DSCSA). The Magic Portal delivers four key elements for DSCSA success:
- Instant access for direct Authorized Trading Partners (ATPs) via personalized magic link email invites and Address Book
- Rapid onboarding for indirect trading partners to apply for portal access with appropriate ATP checks and “courtesy requests”
- DSCSA Verification, Tracing, and Exceptions Management including asynchronous review and resolution of high-stakes verifications
- DSCSA Control Tower with tickets, internal and shared chat boxes, links to 3911 and quality incident numbers, with filters, downloading and follow-the-incident views
“Self-service portals have been enshrined in federal guidances as a bridge to interoperability,” said Alex Colgan, Head of Marketing & Partnerships at LedgerDomain. “Far-sighted manufacturers asked us to take this self-service concept to the next level and build them a portal which provides their direct and indirect DSCSA counterparts a way to carry out all their compliance activities without paperwork or machine-to-machine (M2M) integrations – unlike traditional static portals, which require extensive and time-intensive onboarding and maintenance. They also specified a ‘third eye’ mode where M2M messages are auto-magically pulled into their control tower.”
The portal was first released to early access customers last month, with self-hosted portal deployments slated for the FDA stabilization period.
By inviting their counterparties to their portal and opening a new channel for DSCSA compliance, manufacturers are simultaneously able to demonstrate their own ATP status to downstream trading partners.
“We’re pleased to support the Magic Portal with our Movilitas.Cloud GxP-compliant solution,” said Marc Blekkink, Product Manager at Engineering Industries eXcellence. “Thanks to our close partnership, credentialed manufacturers can turn a manual verification request into a hands-free VRS interaction, saving time and allowing even the smallest ATPs to easily manage saleable returns, compliance audits, and more.”
“ATP confirmation is an essential element of DSCSA compliance,” said David Kessler, President of Legisym. “Our OCI-standard verifiable ATP credentials can be fired off to counterparties as part of initial onboarding to pave the way for a trusted and secure channel for DSCSA compliance.”
As members of the Open Credentialing Initiative (OCI) and the Partnership for DSCSA Governance (PDG), LedgerDomain 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.
LedgerDomain will be hosting a webinar on Monday, October 30th showcasing the Magic Portal. Sign up today at ledgerdomain.com/magic-portal-webinar.
ABOUT LEDGERDOMAIN & XATP
XATP member services enable ATPs, including global enterprises, health centers, and independent pharmacists to comply with DSCSA requirements for authentication, enhanced verification, tracing, 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.