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.
What to look for when you're buying.
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
What it tests: Are Key Data Elements captured at each Critical Tracking Event as work happens, not later?
Why it matters: Retrospective capture fails FDA §1.1315.
V5: Kiosk capture at receiving, transformation, creation and shipping; nothing enters or leaves without the KDE.
Sortable spreadsheet in 24h
What it tests: Can the required sortable spreadsheet be produced within 24 hours for any traceability lot?
Why it matters: The rule specifies 24 hours; anything slower is a violation.
V5: One-click sortable spreadsheet per the FDA template.
FTL scope engine
What it tests: Does the system apply the Food Traceability List correctly to your SKUs?
Why it matters: Over-scoping wastes work; under-scoping is a violation.
V5: SKU-level FTL determination with rationale on each item.
One-up / one-down
What it tests: Are supplier and customer linkages captured at transaction time?
Why it matters: Bioterrorism Act §306 and 204 both require it.
V5: ASN/receiving and shipping capture upstream and downstream identifiers.
Recall simulation
What it tests: Can you run a mock recall by traceability lot in minutes?
Why it matters: FDA and audit programs require demonstration.
V5: Mock recall executes across CTEs in the sortable spreadsheet.
Spreadsheet vs legacy QMS vs V5.
How V5 FSMA 204 compares to spreadsheet trace and to a bolted-on trace tool.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| KDE at CTE on floor | Retrospective | Sometimes | Kiosk-native at each CTE |
| 24h sortable spreadsheet | Days | Hours-days | One click |
| FTL scope engine | Manual | Static | Rule-driven per SKU |
| One-up / one-down | Manual | Partial | Native at ASN/ship |
The clauses, verbatim — and how V5 answers each.
FSMA 204 clauses and V5's answer.
Records must be provided in an electronic sortable spreadsheet within 24 hours of an official request...
V5: One-click export in the FDA-specified format.
Records must be maintained for 2 years...
V5: Native record retention with immutable trail.
Additional recordkeeping for high-risk foods...
V5: FTL-scoped items carry KDE at each CTE by default.
One-up / one-down recordkeeping requirements...
V5: Upstream/downstream captured at transaction.
Step by step on the floor.
V5 makes 204 compliance an operational by-product.
- 1Receive
Upstream KDE captured
Supplier, TLC, quantity, receipt time captured at receiving kiosk.
- 2Transform
Transformation event linked
Input TLCs linked to output TLC as work happens.
- 3Create
Creation event linked
New TLC assigned with the linked inputs.
- 4Ship
Downstream KDE captured
Customer, TLC, ship time captured at shipping.
- 5On request
Sortable spreadsheet
24h clock is a one-click export.
The math, with the assumptions visible.
FSMA 204 ROI is dominated by avoided enforcement and by daily labour eliminated.
Trace-lot pull time
Live linkage.
Mock recall duration
Recall simulation runs on the same record set.
Retrospective KDE re-entry
Captured at CTE by kiosk.
Most sites cover the module cost in avoided re-entry labour alone.
What changed on the floor.
Setting
A leafy-greens processor covered by FTL.
Before
KDE assembled weekly from paper; mock recall took a full shift.
After
KDE captured at every CTE in real time; last mock recall completed in 24 minutes.
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.