Lloyd Mager The US drug supply chain regulation envisions a secure Electronic Drug Distribution system that requires authorized trading partners to access and interact with it. So, what exactly is this system and what are your responsibilities within it?
DSCSA does not mandate aggregation. Does that mean you shouldn’t aggregate your data?
Of course not! Since everyone, including manufacturers, will rely on the practice of inference. Aggregation is in fact necessary for interoperable trade in the drug supply chain.
What most manufacturers and distributors don’t yet realize is that aggregated information will become a key component of their exception handling strategy and their ability to demonstrate control.
The industry will need the ability to collaborate with each other and connect to relevant distributed data sets within an interoperable ecosystem by November 2023…
Interoperability is a characteristic of an ability to work with others. DSCSA requires that ATPs be able to work among themselves to exchange product information as needed for the purpose of transaction, product verification or trace for various suspect/illegitimate product reasons, and for enhancement of industry recall mechanisms…