Supplement batch and lot traceability software for the full record

Traceability is a chain of recorded events

A lot number becomes useful when it connects the material received, the checks performed, the batch that consumed it, the finished lot created, and the shipments that carried that lot. A directory of lot codes cannot answer a recall question unless those relationships were recorded as the work happened.

ERRA records the forward and backward genealogy. Starting from an ingredient lot, a production batch, or a finished lot, the trace surface follows the connected records and calculates the affected scope. Shipment and consignee records extend that scope when those workflows are enabled.

The record from receipt to recall

• Receive a supplier lot against a purchase order and attach its supporting documents.
• Record CoA results, testing requirements, disposition, and any quality hold.
• Consume specific ingredient lots in a production batch tied to an exact formula version.
• Record in-process checks, equipment use, yield, final testing, and QA release.
• Create finished-lot inventory and allocate it to recorded shipments.
• Trace forward to affected finished lots and consignees or backward to source lots and suppliers.
• Run a timed mock recall drill and keep the drill record in the audit trail.

What the system cannot infer

Traceability is only as complete as the events recorded in the chain. A shipment maintained outside the system cannot appear in a calculated consignee scope until its record is added. Imported documents can support a record, but a document by itself does not establish the relationships between lots, batches, and shipments.

A useful evaluation should test one real path in both directions. Pick a finished lot and ask which ingredient lots went in. Then pick one ingredient lot and ask which finished lots and shipments are affected.

Questions to ask during an evaluation

• Does production record the exact source lots consumed rather than the ingredient name alone?
• Can a released batch be tied to the immutable formula version used to make it?
• Do quality holds and dispositions remain visible in the genealogy?
• Can the system trace both forward and backward from any recorded node?
• Does recall scope identify finished lots, shipments, and consignees when those records exist?
• Is the mock recall timed and preserved as an auditable event?

Primary sources

• 21 CFR 111.260: batch production record requirements
• 21 CFR 111.455: holding and distributing operations
• FDA industry guidance for recalls

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