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Compliance

The Complete Guide to Lot Traceability for FDA-Regulated Manufacturers

March 1, 2026

Regulated manufacturers do not get to treat lot history as optional. Whether you ship under FDA, GMP, or customer quality agreements, you need to answer three questions fast: what went into this batch, where did it go, and who touched it?

Paper travelers and disconnected spreadsheets can pass an audit once. They fail when a recall window is measured in hours, not days, and when multiple plants need the same genealogy story.

End-to-end lot traceability means every consume, produce, and ship event is linked to the same lot identity. That is how you produce a one-up / one-down report without assembling it by hand.

Swift WMS is built around lot and license-plate tracking so genealogy is a query, not a war room exercise. Pair that with document storage for certificates and you close the loop customers and auditors actually care about.