DSCSA Exploration Sandboxes

The Center often develops Supply Chain simulations to aid Trading Partners and Solution Developers in understanding the complex decision making, processes and information flows that stem from regulatory impact and business operation changes. The Center has developed simulations that include a wide variety of actors, supply chain configurations and exceptions. These simulations take into consideration regulatory and operational rules as well as standardized and experimental data flows. Each simulation exercises a defined set of supply chain stakeholders resulting in datasets that you and your team can view and interact with.

Purpose of the Simulation Sandboxes

The simulations will allow you to enter into a DSCSA contexed supply chain, explore datasets representing:

  • Product exchanged with Trading Partners

  • TI/TS data exchanged with Trading Partners

  • Current Physical Inventory

  • Alerts that represent system signals that may cause you to enter into an investigate

Exercises Available to you:

In a Simulation Sandbox, you and your team become one of the simulated Trading Partners (or other roles). You can explore DSCSA data and product exchanges that your simulated company has participated in. You can also interact with other companies participating in the sandbox.

Data Available:

  • Product Master Data

  • Supplier Master Data

  • Customer Master Data

  • TI/TS data received from your Suppliers

  • TI/TS data sent to your Customers

Product Exchanges:

  • Check your Production (Manufacturers & Repackagers)

  • Check your Current Inventory

  • Check Products Quarantined

Processes you can execute:

  • View System Alerts

  • Email a simulated Supplier, Customer or Regulator

  • File a 3911 with the [simulated] FDA

  • Verify a product with the Manufacturer or Repackager

  • Trace a Product (TI Request & TI Response)

  • Return a Product to a Supplier

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