Legisym First to Complete Compliance Audit to OCI Credential Issuer Conformance Criteria to Validate Pharmaceutical Authorized Trading Partners (ATP)
DURHAM, NC, March 5, 2024 – Drummond Group, LLC, a trusted provider of compliance, standards, and cybersecurity testing, certification, and validation services, today announced that Legisym has completed the Open Credentialing Initiative (OCI) Credential Issuer Conformance Criteria. Legisym is the first credential service provider to successfully complete the OCI Credential Issuer conformance criteria audit.
OCI is a collaborative industry effort enabling pharmaceutical supply chain actors to establish digital proof of identity, licensure status, and information authorship using digital wallets and verifiable credentials.
Legisym demonstrated all required criteria during the audit and thus demonstrated a documented process to both validate a pharmaceutical organization’s existence and identity as well as the identity and authority of the organization’s representative to act on behalf of that Organization and to verify an organization’s Authorized Trading Partner (ATP) status as defined by DSCSA. OCI Credential Issuers are required to follow Section 2 of NIST Special Publication 800-63A for remote identity proofing to NIST Identity Assurance Level 2 (IAL2). Beyond the required due diligence to issue verifiable credentials, Legisym, as an OCI Credential Issuer, is required to and demonstrated full compliance to all required OCI Credential Issuer credential monitoring criteria. During a credential’s validity period, Legisym performs continuous monitoring to identify possible triggers for revocation or recertification.
“I am pleased to announce that Legisym has successfully passed all required OCI Credential Issuer Conformance Criteria, including some optional conformance criteria, and has now achieved Drummond CertifiedTM status,” said Aaron Gomez, Supply Chain Security Business Unit Leader.
David Kessler, Co-Owner, and President of Legisym said, “Patrick Paschall, Supply Chain Security Auditor, and the team at Drummond Group always perform at the highest level of professionalism and thoroughness. This makes us better and ensures our solution offerings exceed expectations.”
Brittany Payson, Director of Product Management & Marketing for Legisym added, “Thank you for all your efforts to thoroughly examine our Credential Solutions™ against OCI’s Conformance Criteria.”
OCI’s requirement for service providers who are directly involved with issuance and maintenance of credentials to be audited, follows the public-private Partnership for DSCSA Governance (PDG)’s directive. The PDG Foundational Blueprint for 2023 Interoperability incorporates advice from FDA, pharmaceutical businesses, and other pharmaceutical supply chain stakeholders. It is foreseen that the OCI Digital Wallet and Credential Issuer Conformance Criteria will be the standard way of validating organizations as ATPs for use by VRS systems to meet DSCSA compliance.
The audit was conducted by Drummond expert auditors, who developed an audit plan based on OCI Credential Issuer Conformance Criteria. Drummond is the sole auditor and has developed a testing plan that successfully executes OCI audits.