FSMA 204 software that captures every KDE — at the moment it happens.
V5 captures Key Data Elements at every Critical Tracking Event — receiving, transformation, creation, shipping — as the work happens, holds the records the rule requires, and produces the sortable spreadsheet FDA can demand within 24 hours.
What breaks without this.
KDEs collected on paper don't survive a 24-hour request
The rule's enforcement date has passed. If the spreadsheet isn't sortable and exportable in 24 hours, you're non-compliant.
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.
Records-by-execution. Compliance, by design.
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 in minutes.
Recall simulation drills
Run a quarterly drill: pick a lot, see every upstream KDE and every downstream shipment in seconds. Closes the loop before a real recall does.
Proof points
- FTL-covered items flagged automatically by GTIN/product master
- KDEs scan-captured at receiving, transformation, creation and shipping
- 24-hour sortable spreadsheet export — FDA format
- Recall drill from any lot in seconds
Built to satisfy
- 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)
Frequently asked questions
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. The sortable spreadsheet must be available to FDA within 24 hours of request.
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, in minutes.
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.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.