Legisym, LLC and Spherity GmbH have closely worked together to bring to maturity a joint offering that meets the security requirements of the U.S. Life Science Market. Legisym as a trusted OCI-aligned Verifiable Credential Issuer, perfectly complements Spherity’s digital wallet technology for managing verifiable credentials in an interoperable way.
As a result of this Spherity-Legisym development, 5 Trading Partners have already been onboarded to the functional solution and are actively exchanging ATP status ahead of DSCSA’s November 27, 2023 deadline.
One solution for all DSCSA Regulated ATP interactions
The verifiable credential technology is used to represent the authorized status of interacting trading partners in a highly efficient, secure, and DSCSA compliant way. To use credentialing for Authorized Trading Partner (ATP) requirements under DSCSA, trading partners need to go through a one-time due diligence onboarding process with Legisym. Once the verifiable credentials are issued, they are stored in a secure digital wallet which comes embedded with the Credentialing Service provided by Spherity. Using this technology enables U.S. pharmaceutical supply chain actors to interact with digital trust as they now can digitally verify their ATP license status in every interaction.
Below outlines the simple path to DSCSA compliance for ATP:
STEP 1: Establishing a Digital Wallet with Spherity
STEP 2: Credential Onboarding with Legisym
STEP 3: Granting Permissions to Your VRS Provider
STEP 4: Monitoring Authorized Trading Partner Interactions
1. Establishing a Digital Wallet with Spherity

With a contract in place, Spherity will configure a secure, private digital wallet enabled for Credentialing Services. Using the provided username and temporary password you will be able to finalize your company account activation.

2. Credential Onboarding with Legisym 

To onboard a new enterprise to the Credentialing Service, you have to access the Enterprise Identity Management within your digital wallet. Here the system guides a User through two simple onboarding screens:

First, you will need to identify who within your organization has the proper authority and documentation required to establish your corporate identity. With the proper documentation, an authorized representative will complete the requested company and contact information. Depending on the verification method you select, the process for approval could take a little as 5 minutes.

Once your Identity Credential has been successfully issued to your Spherity wallet, you will be directed to the Authorized Trading Partner (ATP) Credential request. Depending on the type of organization you are representing (ie – Manufacturer, Wholesaler, or Dispenser), you will need to enter either your Board of Pharmacy (BoP) License Number or your FDA Establishment Identifier Number.

Similar to the Identity Credential, Legisym performs due diligence in accordance to the OCI Credential Issuer Conformance Criteria prior to issuing an ATP Credential to your Spherity wallet.

3. Granting Permissions to Your VRS Provider

To use your credentials in product verifications, Spherity integrates with your existing VRS Provider. With your permission, your VRS provider will be able to issue and verify credentials presentations. The following VRS Providers are already integrated with Spherity:

SAP Life Sciences
March 30, 2021 by 

 In order to provide our customers with the best solution for compliance with verifying the identity and authorized trading status of partners, SAP chose an open, interoperable technology to validate all stakeholders in the pharmaceutical supply chain, including competitors.

Together with SAP partner and wallet provider Spherity GmbH, verifiable credentials issuer Legisym LLC, and leading pharmaceutical manufacturers and U.S. wholesalers, as well as other serialization solution providers, SAP proved the ability of SSI to validate authorized trading partner status in indirect trade relationships as they occur during verification of product packs as required by U.S. legislation…read more

rfxcel, Part of Antares Vision Group
March 24, 2021 by 

rfxcel, a global leader in digital supply chain traceability solutions, today announced that it would use the Open Credentialing Initiative (OCI) to help customers comply with the upcoming authorized trading partner (ATP) requirements of the U.S. Drug Supply Chain Security Act (DSCSA).

By November 27, 2023, only ATPs will be permitted to exchange information in the U.S. pharmaceutical supply chain. To test the OCI solution’s effectiveness in meeting this requirement, rfxcel joined the OCI ATP pilot, initiated and supported by key industry participants, including manufacturers, a wholesaler, and a dispenser.

In the pilot, rfxcel partnered with SAP to test the OCI solution, which was built using Spherity’s identity wallet and Legisym’s identity/license verification service. It is based on open, published standards that can be implemented by providers and avoid “vendor-lock” to ensure independence and interoperability…read more

4. Monitoring Your Authorized Trading Partner Interactions

Monitor and investigate every credential-based Product Identifier (PI) Verification interaction, with full transparency and complete audit-trails.

Keep the overview of all verified trading partners which have previously been interacted with.

Schedule a one-on-one meeting to learn more test drive Spherity’s Credentialing Service powered by Legisym-Issued Verifiable Credentials today.
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