Industry wide pilot for DSCSA Authorized Trading Partner status verification

In partnership with the Healthcare Distribution Alliance (HDA) and the Center for Supply Chain Studies, Spherity implemented with global pharmaceutical manufacturers, wholesalers, SAP, rfxcel and Legisym a solution to verify the Authorized Trading Partner (ATP) status in the context of the US Drug Supply Chain Security Act (DSCSA).

Based on Spherity’s Cloud Identity Wallet, the pilot group establishes a Verifiable Credential based ecosystem to support existing Product Identifier Verification scenarios for DSCSA saleable returns. The DSCSA requires US pharmaceutical supply chain actors to prove that they only interact with trading partners that are “authorized”. Trading partners are “authorized” when they hold as a wholesaler a state license and as manufacturer a FDA Entity Identifier that is valid at the time of interaction.

The Solution

An identity layer built on Decentralized Identifiers and with Verifiable Credentials enables manufacturers, wholesalers and dispensers to identify any previously unknown trading partner and to verify it’s Authorized Trading Partner status in real time. The Authorized Trading Partner pilot group implemented a solution by utilizing the existing GS1 Lightweight Messaging Standard for the exchange of Product Identifier (PI) Verification messages between trading partners. With the Authorized Trading Partner pilot implementation, a trading partner or Verification Routing Service (VRS) provider can attach the Authorized Trading Partner Credential to the header of the Product Identifier (PI) Verification request or response message.

The Authorized Trading Partner credential traveling with the Product Identifier (PI) Verification message is issued and maintained by providers such as Legisym. Legisym has a database of state license and FDA Entity Identifier (FEI) records for pharmaceutical companies. This validated and trusted source is used to issue Authorized Trading Partner credentials to trading partners. Without having an own direct access to a registry of state licenses, every trading partner in the ecosystem can now verify the Authorized Trading Partner status of other actors in a more efficient way.

Benefits

  • Interoperable and standardizable solution to meet industry governance guidelines
  • Agnostic to GS1 Lightweight Messaging Standard for the Verification of Product Identifiers
  • Foundation for a digital identity layer for DSCSA requirements
  • Fair pricing model for all kind of trading partners

Features

  • Monitoring and audit module for Product Identifier verifications
  • API Integration for credential issuers to link the licenses to the ATP Credential
  • API Integration for Verification Routing Service providers to fetch and verify ATP Credentials

PILOT PROFILE

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In partnership with

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Project Scope
DSCSA-Compliant Verification of Authorized Trading Partners

Industry
Pharmaceutical

Country
USA

Video

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Using DSCSA Authorized Trading Partner Credentials in the Saleable Returns process

Client Testimonial

“Based on our successful collaboration with Spherity, the industry agreed to further investigate the usage of W3C Decentralized Identifiers and Verifiable Credentials technology to electronically verify Authorized Trading Partners in the saleable returns verification process in an industry-wide pilot.”

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Dr. Oliver Nuernberg
Chief Product Owner, SAP Life Sciences

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