DSCSA Product Ownership Traceability - Interoperability Pilot

We are pleased to invite you to participate in an industry pilot of DSCSA Tracing using C4SCS simulated supply chain tools.

In February 2023, the Partnership for DSCSA Governance (PDG) published Chapter 5 of its Foundational Blueprint for 2023, defining a tracing architecture functional design. It includes TI Request and TI Response message designs, JSON schemas, and credential usage that incorporate data specifications developed throughout the PDG design process. In addition, the design includes several methods for exchanging TI Request and Response messages (e.g., email, OpenAPI, DIDComm, etc.) to support three Levels of Capability Maturity for users implementing trace solutions.

Based on the PDG Foundational Blueprint for 2023 Interoperability, this pilot will enable trading partners and other stakeholders to gain hands-on experience with DSCSA tracing within a simulated supply chain.

The pilot will leverage C4SCS simulated supply chain tools and data to test interoperability between DSCSA TI Trace solutions, and the ability of those solutions to accommodate various DSCSA investigation and interaction scenarios and volume/traffic levels.

As a participant in this pilot, you will have the opportunity to test and optimize your own tracing and verification processes within the simulated supply chain, and to collaborate with other stakeholders such as suppliers, manufacturers, distributors, and regulatory bodies. You will also have access to reports, dashboards, and visualizations that will help you analyze the effectiveness of your process and identify areas for improvement.

If you are interested in participating in this pilot, please contact Bob Celeste at RCeleste@C4SCS.org by August 11, 2023. We will provide you with further details and instructions for participation.

The DSCSA Trace Interoperability Pilot

The Pilot will be backed by Supply Chain simulations generating Trade Partner, Product Master Data, DSCSA Transaction Information, and Product Inventories for a defined set of Trading Partners. Transaction Information will be represented by GS1 EPCIS record sets, Product Information Verification will use VRS-design record sets and Transaction Information Requests and Responses will use PDG TI Request / Response JSON formats. PI Verification and TI Trace Authentication and Authorization will be accomplished by using the recently adopted, OCI-Specified ATP, ATP-Equivalent and DSCSA Authority Verifiable Credential architecture.

The DSCSA Trace Interoperability Pilot will support Trace Solutions in achieving interoperability:

  1. Test PDG Levels of Maturity 1, 2, and 3

  2. Exchange PDG TI Request & Response Messages

  3. Exchange OCI ATP, ATP-Equivalent and DSCSA Authority credentials for Authentication/Authorization

Trace Scenario Sandboxes

The Pilot will use the output (processes, rules, schemas, etc.) of the VirtualPilot as a blueprint to execute a pilot involving Trading Partners and Solution Providers.

Trace Scenario Sandboxes will support Trading Partners and other Stakeholders to explore:

  1. Investigation & Response Processes

  2. Post-2023 Stabilization Period as TI records transition from lot-based to serialized

  3. The effect of TI Exchange and Supply Chain scenarios on PI Verification and Tracing

Supporting the Effort:

The Center is seeking sponsors for this work. Sponsors may demonstrate their solutions at an Industry Demo-Day to be held at the conclusion of the Pilot.

If you are interested in exploring sponsorship or participation in this effort, please contact Bob Celeste at rceleste@c4scs.org