Overview of Interoperability Committee Work

Formation and operation of PDG is not dependent on any one specific technical vision for how interoperability should be achieved. The specific technical vision to be advanced by PDG will be determined by PDG using its decision-making mechanisms that promote balance, sector-neutrality, and equitability. At a general level, however, PDG will govern interoperable verification and tracing (as required by DSCSA) and practices and processes that impact the integrity and reliability of interoperable verification and tracing. This includes the practices and processes to create, store, and transmit data intended to be exchanged under DSCSA, but excludes internal company processes and practices. Collectively, the technical vision that includes these practices and processes, as well as the technology for accomplishing them, are referred to as the “blueprint for interoperability.” The primary deliverable of PDG within the first year is this blueprint for interoperability, the establishment of which will help to further define the scope of governance moving forward. More specifically, it is expected that the blueprint for interoperability will:

• Define a database architecture (e.g., centralized, semi-centralized, distributed) for DSCSA interoperability).
• Define necessary governance body activities (e.g., whether the body will issue best practices or will identify technical specifications to support interoperability).
• Define the vision for interoperability (e.g., a model for credentialing tracing services, establishment of technical systems to support interoperability).
• Define the use cases and business requirements for DSCSA interoperability.
• Identify standards and/or functional specifications needed for DSCSA interoperability.
• Identify any infrastructure that may be needed for DSCSA interoperability.

As a way of driving development and completion of the Interoperability Blueprint, PDG’s Interoperability Committee is supported by four work groups. The work groups include (1) Credentialing and User Authentication; (2) Serialized TI/TS Data Exchange; (3) Verification Architecture; and (4) Tracing Architecture. The outputs of these work groups are synthesized by the Interoperability Committee into a comprehensive vision for interoperability.

• Credentialing and User Authentication Work Group is responsible for defining the systems and processes by which trading partners/users will demonstrate permission to request and exchange data in the governed environment, including “authorized” status.
• Serialized TI/TS Data Exchange Work Group is responsible for defining any systems and processes and business requirements, and identifying messaging standards needed to enable interoperable electronic verification and tracing.
• Verification Architecture Work Group is responsible for defining systems and processes by which trading partners can implement the requirements to verify product in an interoperable, secure electronic manner.
• Tracing Architecture Work Group is responsible for defining systems and processes by which trading partners can implement the requirements to trace product in an interoperable, secure electronic manner.