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Supply Chain Communication
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?
Beyond DSCSA: Aggregation and Exceptions
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.
DSCSA for Pharmacies: 3 Must Knows
DSCSA for Pharmacies: 3 Must Knows Data Exchange | Partner Verification | Tracing Requests January 17th, 2023 This is the year the pharmaceutical supply chain must comply with the FDA’s Drug Supply Chain Security Act (DSCSA). These requirements must be met in order to operate within the US Drug Supply Chain. As the primary touchpoint … Read more
The Drug Manufacturer’s DSCSA Dilemma
A decade’s worth of time has expired since the Drug Supply Chain Security Act (DSCSA) was passed to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. This November marks the start of the 12 month countdown requiring pharmaceutical trading partners to comply with the law. As time quickly slips away, trading partners are still left with unanswered questions and serious operational risks if found to be non-compliant by November 27, 2023.
Resolvers: The Internet’s Address Book
What exactly does it mean when someone says they have configured a “resolver?” This quick post will explain the concept of a resolver, how Trust.med is using resolvers to address DSCSA compliance, and how you can start using resolvers today…
All for One, One for All: Interoperable Ecosystems for DSCSA
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…
Sharing Should Be Easy: Have You Achieved Interoperability for DSCSA Compliance?
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…
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