FDA Food Traceability, Captured Automatically as You Work

FDA food traceability software helps food businesses comply with the FSMA Section 204 Food Traceability Rule by identifying Food Traceability List items, assigning traceability lot codes, recording Critical Tracking Events with their Key Data Elements, and producing the records FDA can request. Biznsbook captures most of these events automatically as goods are received, transferred, and shipped.

FSMA Section 204 is the FDA Food Traceability Final Rule (21 CFR Part 1, Subpart S). It requires anyone who manufactures, processes, packs, or holds foods on the Food Traceability List to keep additional records of Critical Tracking Events and Key Data Elements, and to provide them to FDA in a sortable electronic spreadsheet within 24 hours of a request.

Critical Tracking Events are the key supply-chain points where traceability data must be recorded — such as receiving, transformation, shipping, harvesting, cooling, and initial packing. Biznsbook records Receiving CTEs on GRNs, Shipping CTEs on sales, paired Shipping and Receiving CTEs on warehouse transfers, and lets you enter harvesting, cooling, and initial packing events manually.

A Traceability Lot Code uniquely identifies a lot of food for tracing. Biznsbook uses the supplier's TLC when it is provided at receipt, or automatically allocates an internal lot code, and propagates that code to destination batches when stock is transferred between warehouses.

Once you flag an item as being on the Food Traceability List, Biznsbook records Critical Tracking Events as part of your normal workflow — a Receiving CTE when you post a GRN, a Shipping CTE when you sell or ship, and paired Shipping/Receiving CTEs on transfers. Non-traceability items are never burdened with extra data entry.

Yes. Biznsbook generates the FDA Electronic Sortable Spreadsheet (ESS) on demand for a date range, or you can queue it from the 24-Hour Response Portal where it is produced in the background and downloaded when ready. The export includes the required fields such as TLC, product description, quantity, CTE type, event date and time, location, and trading-partner GLN.

Yes. Search by batch or lot number, supplier TLC, or GRN number and Biznsbook shows the full backward (inbound) chain from suppliers and GRNs and the forward (outbound) chain to customers and shipments, including a visual CTE event timeline that follows batch genealogy.

FSMA 204 requires a written Traceability Plan. Biznsbook stores a versioned plan with the effective date, point of contact, your data procedures, FTL identification process, and TLC management description, plus an optional farm map upload for originators. Activating a new version automatically archives the previous one.

Biznsbook retains traceability records for 24 months in line with the FSMA 204 record-keeping requirement. A daily scan raises an in-app warning as records approach the end of the retention window so you can export or archive them — records are never deleted automatically.

FDA FSMA 204 Food Traceability is a compliance module that activates inside your Biznsbook ERP and shares the same items, batches, suppliers, GRNs, and sales — so there is no separate traceability silo to maintain. Talk to sales to enable it for your account.