The Drug Supply Chain Security Act is the US framework for specific prescription-drug supply-chain requirements. An implementation review starts with the organization, product and transaction involved.
SAME DATA. FURTHER GOOD.FDA publishes guidance covering product identifiers, tracing, verification and other DSCSA topics. Use the applicable documents to establish your organization’s requirements; requirements and policies should not be inferred from a software feature list.
A requirement may involve a procedure, a product record, an exchange with a partner and a person authorized to make a decision. Use an operating example to connect those pieces. The software evaluation then asks how the applicable work is supported and where evidence is available.
Confirm the organization, product and transaction.
Define the action required for that situation.
Identify the information supporting the action.
Name the person responsible for review or escalation.
ILLUSTRATIVE WORKFLOW · THE IMPLEMENTATION FOLLOWS YOUR OPERATING REQUIREMENTS
After your responsible team establishes the scope, translate it into operational scenarios. This makes it possible to examine a product demonstration without confusing a screen, a policy and an actual working process.
Which information must be available, and who provides it?
Which receiving or shipping activity must be connected to that record?
What must happen when information is missing or a transaction requires review?
Prepare a responsibility matrix for operations, compliance, IT and external partners. For every requirement, record the process owner, the system involved and the evidence needed to show the process works.
Review current FDA exemption materials separately from the general implementation requirements. Scope, conditions and dates matter; do not treat an exemption as a blanket replacement for the applicable obligations.
Connect serialized product records, receiving and shipping events, and trading-partner data in the workflows your team uses every day.
Explore dscsa workflowsAn exemption is useful only when its scope matches your organization, the requirement and the transaction being considered.
Explore dscsa exemptionsUse a consistent set of operational tests to compare what vendors demonstrate, what the implementation requires and what your team needs to own.
Explore software evaluation checklistUse real workflows, representative data and clear acceptance criteria to shape the implementation conversation.
Explore implementationYour systems. Your partners. The task you need to complete.
Discuss your workflow
