DSCSA Authorized Trading Partner Credentialing
Enabling trading partners to exchange and verify the ATP status in DSCSA interactions
OCI supports, specifies and maintains an architecture that enables trading partners to identify and verify in electronic interactions the authorized status of other supply chain actors. The interoperable and standard based design principle of OCI architecture for ATPs enables services that are compliant to DSCSA requirements and do not require any technical expertise from trading partners.
Schedule a one-on-one meeting to learn more about the ATP Credentialing.
How OCI Supports DSCSA Compliance
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DSCSA Requirement
DSCSA Authorized Trading Partners Explained
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Challenge
DSCSA-Compliant Authorized Trading Partners
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Compliance
DSCSA ATP Credentialing
Credentialing and Interoperability for Saleable Returns Verification
For DSCSA compliant interaction for product verification, the acting trading partners need to ensure that they only interact with other trading partners that are authorized. OCI provides an architecture to establish DSCSA compliant interactions following Authorized Trading Partners requirements.
The Product Identifier Verification Process
1. Onboarding with identity and license
Credential Service Provider starts one-time onboarding process by verifying the company´s identity and license status of the trading partner. When due diligence is passed, trading partner receives an identity and ATP credential. .
*Credential issuer will regularly monitor the legitimacy of the applicant organization and license status to ensure DSCSA objectives.
2. Digital Wallet
Trading Partner uses a Digital Wallet to manage the company´s digital identity and acquired credentials. Trading partner can provide VRS his provider API access to use the ATP credentials in Saleable Returns verifications or to verify inbound ATP Credentials from other Trading Partners.
3. Product Verification
Integrated Service Providers access and verify trading partners’ credentials attached to outbound and inbound messages, also when no prior direct business relationship exists. The Product Verification process is in accordance with GS1 Guideline, requiring no technical integration from trading partners.
Building Blocks of the ATP Credentialing
OCI establishes architecture, guidelines, and specifications in an open environment where trading partners, solution providers, and standard organizations develop DSCSA compliant solutions. All OCI conformant providers use the same protocols, specifications, and verification mechanisms to ensure interoperability.
The OCI-maintained architecture is based on three main building blocks that support trading partners in verifying their identities and ATP status and exchanging data in a secure and privacy-preserving manner.
1. Specification
The OCI working group for ATP credentialing specifies building blocks required to support Trading Partners meeting DSCSA requirements for ATPs.
Key building blocks:
Digital Wallet
Identity verification
Credential Schemas
APIs
Specifications are published on the OCI GitHub page.
2. Standardization
OCI utilizes existing standards to ensure interoperability.
Standard organizations that OCI recognizes:
GS1
W3C
NIST
OCI collaborates with the GS1 Healthcare US to standardize the usage of credentialing in existing messaging protocols.
3. Governance
OCI established a set of governance rules and policies for their member organizations.
The established governance rules ensure that also non-OCI members are able to adopt the developed solutions.
What Community is Saying
“A cross functional team realized there was a compliance issue with digital systems and assuring an Authorized trading partner ( ATP.) is using the digital system. The credentialing process is the first proven industry digital process that addresses ATP compliance gap of knowing if the company is an Authorized Trading partner per DSCSA requirements using the system. This is a foundation for 2023.”
Dave Mason, Novartis Supply Chain Compliance and Serialization
“The team is producing a Roadmap for Adoption and has established the necessary facilities to move to production in the next phases.”
Bob Celeste, Founder, Center for Supply Chain Studies
“The ATP pilot is the most comprehensive effort to address the upcoming Authorized Trading Partner requirement for DSCSA. rfxcel was impressed to see how seamlessly it integrated with our solution. All participants work well together and rfxcel is excited to see this adopted by other solution providers and the industry.”
Herb Wong, VP Marketing & Strategic Initiatives, rfxcel
“Assurance that the FDA’s Data Integrity compliance indicators and the DEA Standards for Electronic Transmissions (Authentication, Nonrepudiation and Message Integrity) are incorporated in this solution.“
Sharon Webster, Novartis Pharmaceutical, AD Market Product Quality
Join the OCI ecosystem to achieve compliance as 2023 approaches.
Meeting 2023 DSCSA compliance requires cooperative efforts by Manufacturers, Wholesale Distributors, Service Providers, Dispensers, and other supply chain actors and stakeholders.
