OmniMedia Associates

Track & Trace

In February 2011, the FDA ran an industry workshop where they unveiled the agency vision for a future pharma track & trace model.

Essentially, this model used item, case and pallet aggregated serialization, captured changes or EPCIS events to a database (centralized or decentralized) capable of queries by unit number, with authentication requirements upon each supply chain participant. Detailed slide presentations given at the workshop can be found here.  
The DQSA, passed in 2013, mandates unit traceability, not track & trace. In our opinion, tracking is knowing where a product is - tracing is knowing where it has been. Inherent in tracking is either allowing inference or mandating scanning of all units at each supply chain transaction - which is likely impractical in the US market given todays technology. So, the DQSA mandates a unit-tracing model in 2023, with hurdles leading up to that date.
OMA can help you make sense out of the different models and the ramifications for your company with each. We also track legislative and rules developments and can "bake" these into a strategy and project for you - complete with providing experienced staff to make it happen at your company. Contact us for a consultation.