FSMA 204 traceability records captured at each tracking event.

• KDEs collected on paper don't survive a 24-hour request

  FDA says it will not enforce the rule before July 20, 2028.

• CTEs at receiving and shipping get missed

  Without scan-gated workflows, operators move the pallet without recording the KDEs — and the chain breaks at the loading dock.

• Suppliers send the data in inconsistent formats

  PDF bills of lading, emailed spreadsheets, vendor portals — none of which slot into a sortable record without weeks of cleanup.

• KDE capture at every CTE — scan-gated

  Receiving, transformation, creation, shipping — V5 enforces the KDE set the rule requires for each event type, captured at the moment the work happens.

• Traceability lot codes generated and linked

  TLC assigned at creation and transformation events, linked forward and backward through every downstream record.

• Supplier data in — multiple formats

  EDI, API, CSV, vendor portal, even structured email — V5 normalises supplier KDEs into your record set.

• 24-hour sortable spreadsheet — on demand

  FDA-ready sortable spreadsheet export covering any lot, any date range, any product — generated.

• Recall simulation drills

  Run a quarterly drill: pick a lot, see every upstream KDE and every downstream shipment. Closes the loop before a real recall does.

V5 makes 204 compliance an operational by-product.

1. Upstream KDE captured. Supplier, TLC, quantity, receipt time captured at receiving kiosk.
2. Transformation event linked. Input TLCs linked to output TLC as work happens.
3. Creation event linked. New TLC assigned with the linked inputs.
4. Downstream KDE captured. Customer, TLC, ship time captured at shipping.

FSMA 204 lives or dies on KDE capture at the moment work happens. Retrospective spreadsheet capture is the failure mode.

• KDE at every CTE, on the floor

  Are Key Data Elements captured at each Critical Tracking Event as work happens, not later? Kiosk capture at receiving, transformation, creation and shipping; nothing enters or leaves without the KDE.

• FTL scope engine

  Does the system apply the Food Traceability List correctly to your SKUs? SKU-level FTL determination with rationale on each item.

• One-up / one-down

  Are supplier and customer linkages captured at transaction time? ASN/receiving and shipping capture upstream and downstream identifiers.

• Recall simulation

  Can you run a mock recall by traceability lot? Mock recall executes across CTEs in the sortable spreadsheet.

How V5 FSMA 204 compares to spreadsheet trace and to a bolted-on trace tool.

FSMA 204 clauses and V5's answer.

• 21 CFR §1.1330

  Native record retention with immutable trail.

• FSMA §204(d)

  FTL-scoped items carry KDE at each CTE by default.

• Bioterrorism Act §306

  Upstream/downstream captured at transaction.

• 21 CFR Part 1 Subpart S (FSMA 204 — Food Traceability)
• Food Traceability List (FTL)
• FSMA §204(d) — additional recordkeeping for high-risk foods
• 21 CFR 117 (Preventive Controls for Human Food)
• Bioterrorism Act §306 (one-up / one-down)

• Food & beverage
• Produce packing
• Bakery & confectionery
• Sausage & meat products
• Traceability & recall
• WMS
• Label design
• FSMA 204
• Key Data Element (KDE)
• Critical Tracking Event (CTE)

What is FSMA 204?

The FDA Food Traceability Rule (21 CFR Part 1 Subpart S) requires additional records — Key Data Elements at Critical Tracking Events — for foods on the Food Traceability List.

Does V5 cover the full KDE set?

Yes — receiving, transformation, creation and shipping events all have their full KDE set captured at the moment the work happens, with the traceability lot code linked forward and backward.

How does V5 handle suppliers that send data on paper?

Supplier KDEs can land via EDI, API, CSV, vendor portal or structured email. For paper-only suppliers, V5 provides a guided intake screen the receiving operator completes at the dock.

Can V5 produce the 24-hour sortable spreadsheet?

Yes — formatted to the FDA template, exportable for any lot or date range,.

How fast can we deploy?

FSMA 204 readiness onboarding is 7–14 days depending on supplier integration scope. Pre-built EDI maps cover the major produce, seafood and dairy carriers.