DSCSA Authorized Trading Partner Program
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 principles of OCI architecture for ATPs enables services that are compliant with 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 Product Verification
DSCSA highlights the important of ensuring that you only interact with Authorized Trading Partners (ATP). OCI provides a foundation for operationally efficient, DSCSA-compliant, interoperable electronic product verification.
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 continue monitoring the organization’s status in the background.
2. Digital Wallet
Trading Partner uses a Digital Wallet to manage the organization’s digital credentials.
3. Product Verification
Service Provider (VRS) connects to wallet to send and check digital ATP credentials in product verifications whether or not a prior direct business relationship exists. The automated process leverages GS1 standards, requiring no technical integration from trading partners.
Pillars of ATP Credentialing
OCI establishes independent architecture, guidelines, and specifications in an open environment where trading partners, solution providers, and standards 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 pillars 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 in meeting DSCSA requirements for ATPs.
Key building blocks:
Digital Wallet
Identity and license verification
Credential schemas
APIs
Specifications are published on the OCI GitHub page.
2. Standardization
OCI utilizes existing standards to ensure interoperability.
Standards 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 has established governance rules and policies for its member organizations and external contributors.
These governance rules enable a fair, independent and flexible approach to the maintenance of our specifications and change management.
What the 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 community to lift all boats!
Meeting DSCSA compliance requires cooperative efforts by Manufacturers, Wholesale Distributors, Service Providers, Dispensers, and other supply chain actors and stakeholders.
