Updates
State of DSCSA: Regulatory & Industry Update out of Louisiana
Louisiana Board has prepared its engagement in the enhanced drug distribution security (EDDS) network in line with PDG’s Blueprint recommendations, including the implementation of OCI-compliant digital credentials
OCI Releases VRS Performance Test Suite to Advance DSCSA Interoperability Efforts
OCI members Spherity and LedgerDomain, together with Engineering Industries eXcellence, announced the launch of an open-source Verification Router Service (VRS) performance test suite.
OCI Celebrates Major Milestone with Independent Audit Results
Drummond Group announces LedgerDomain, Legisym, and Spherity have completed OCI Conformance Program audits
Drummond Group Announces Completion of LedgerDomain OCI Digital Wallet Compliance Criteria Audit
LedgerDomain has successfully completed OCI Digital Wallet Conformance Criteria Audit to validate Pharmaceutical Authorized Trading Partners (ATP).
Drummond Group Announces Completion of Legisym OCI Credential Issuer Conformance Criteria Audit
Legisym First to Complete Compliance Audit to OCI Credential Issuer Conformance Criteria to Validate Pharmaceutical Authorized Trading Partners (ATP)
DSCSA 2024 or 2023 Déjà Vu?
A look at the challenges that need to be addressed during the FDA Stabilization Period.
Drummond Group Announces Completion of Spherity OCI Digital Wallet Compliance Criteria Audit
Spherity First to Complete Compliance Audit To OCI Digital Wallet Conformance Criteria to Validate Pharmaceutical Authorized Trading Partners (ATP)
LedgerDomain and Spherity Surpass OCI Performance Standards in Latest API Tests
LedgerDomain and Spherity, leading providers in digital credentialing services, today announced results from their latest performance testing, exceeding the current OCI requirements for the U.S. pharmaceutical supply chain under DSCSA.
OCI's Response to the FDA’s Request for Progress Reports on the Stabilization Period
OCI is honored to respond to the FDA’s request for progress reports on the Stabilization Period as we collaborate to ensure compliance with DSCSA requirements for secure, interoperable, and electronically traceable products at the package level.
OCI’s DSCSA Interoperability Specification 3.3 Expands Support to Virtual Manufacturers
The Open Credentialing Initiative (OCI), the leading driver of trusted digital interactions within the U.S. pharmaceutical supply chain, is pleased to publish its DSCSA Interoperability Specification version 3.3. This latest update incorporates support for virtual manufacturers to obtain credentials for the purposes of verification, tracing, and other activities under the Drug Supply Chain Security Act (DSCSA).
Who Are You Sharing Information With? DSCSA Enhanced Drug Distribution Security System - A Point of View
PI Verification and Trace records are part of your official record for DSCSA investigations. Traditional authentication and authorization methods through onboarding procedures suffer from vulnerabilities, delays, and interoperability issues. The industry has turned to the promising world of decentralized identity and verifiable credentials to address these shortcomings.
Are you concerned over DSCSA implementation and supply chain disruption?
Four major DSCSA violation observations were recently made by the FDA. The warning issued by FDA confirms not prioritizing any of the DSCSA requirements will not slip in their inspections.
The Center for Supply Chain Studies Launches DSCSA Tracing Pilot to Drive Pharmaceutical Supply Chain Interoperability
The Center for Supply Chain Studies (C4SCS) is proud to announce the commencement of its DSCSA Tracing Pilot and Exploration Sandboxes. As part of this initiative, pharmaceutical manufacturers, wholesalers, hospitals, retail pharmacies, and solution providers have new tools to achieve enhanced drug distribution security as mandated by the U.S. Drug Supply Chain Security Act (DSCSA).
OCI’s DSCSA Interoperability Specification 3.2 Expands Support to DSCSA Authorities and ATP Equivalents
The Open Credentialing Initiative (OCI), the leading driver of trusted digital interactions within the U.S. pharmaceutical supply chain, is pleased to publish its DSCSA Interoperability Specification version 3.2. This update expands the credentialing ecosystem to include federal and state authorities as well as trading partners that are not required to register with FDA or obtain state licenses under the Drug Supply Chain Security Act (DSCSA).
Guest Blog: Spherity — EU Digital Product Passports and enabling compliance in the US pharmaceutical supply chain
In the DIF guest blog, the Spherity team explains how they leverage decentralized identity capabilities in their work on Digital Product Passports in the EU and promote compliance with the new pharmaceutical industry regulations, DSCSA in the US.