Executive summary. Product tracing is a continuous chain of transaction records. Each one has to hold up months later, when the person reading it was not there.
Definition
Product tracing records identify a transaction and the parties, product, and timing associated with it.
Start with the transaction
A receiving or transfer record links product identity, trading partner, transaction date, and the evidence supplied for that transaction. A later reviewer should be able to reconstruct what happened from the record alone.
Keep the source evidence separate from the working view your team uses day to day. Source documents support verification. The working view helps staff find exceptions and clear queues.
Retention is part of the workflow
A retention rule only works when records stay retrievable by the identifiers a regulator, supplier, or investigator will actually use. Test retrieval against realistic requests.
Corrections should preserve the original record and explain the change. A value replaced without provenance makes an exception harder to investigate.
Frequently asked questions
Does product tracing mean every record has the same format?
No. DSCSA requirements and interoperable implementation practices define the required information and verification expectations. Organizations still need controlled mappings between their own operational systems.
Referenced standards and further reading
- FDA: Drug Supply Chain Security Act ↗U.S. Food and Drug Administration
Related articles
DSCSA traceability and exception handling →
Enhanced drug distribution security and serialized product data →
Suspect and illegitimate product: designing the response path →