Traceability plan
A written plan describing procedures to identify FTL foods, assign lot codes, capture KDEs, and produce records within 24 hours — present and complete, or the pack does not release.
The most rigorous FSMA 204 recordkeeping service a food company can use.
TraceReady assembles a documentation-complete traceability record pack — every Key Data Element, every Critical Tracking Event, the traceability plan, the lot-code architecture, and the 24-hour FDA-ready spreadsheet — checked against the letter of 21 CFR 1 Subpart S before a specialist releases it.
Every subsection of 21 CFR 1 Subpart SAll KDEs and CTEs, gate-checkedFTL classification · lot-code scheme · planSpecialist release on every pack5-business-day SLA
Why packs fail
A single missing KDE can trigger a warning letter or lost shelf space.
A food company's FSMA 204 compliance is only as strong as its recordkeeping. Miss a Key Data Element at a Critical Tracking Event, fail to link lots through a transformation, or lack a written traceability plan — and the FDA can issue a warning letter, or a retailer can delist the product.
Most companies run this by hand, from spreadsheets and disconnected ERP fields, once or twice a year. The regulation has not been read end-to-end since the last time it mattered. That is exactly where completeness gaps hide.
TraceReady exists to close that gap with a single, exhaustive standard applied identically to every file.
1 of 5
missing KDEs is enough to jeopardize compliance
The benchmark
Measured against the letter of the regulation — subsection by subsection.
We do not summarize the law and hope. Every pack is scored against a versioned rule pack tied to the exact text of 21 CFR 1 Subpart S. These are the provisions each pack is held to.
Key Data Elements (KDEs)
All required KDEs at each CTE (receiving, transforming, shipping) are captured and linked by traceability lot code — verified against the FTL product category.
Traceability lot code
A lot code assigned at the point of production or receipt, maintained through transformation and distribution, and recorded in every KDE record.
24-hour production
The electronic sortable spreadsheet is verified to be producible within 24 hours of an FDA request, with all required fields and sortable format.
FTL applicability
Every product is classified against the Food Traceability List; exemptions and commingling/transformation logic are documented and reviewed.
Record retention
Records are retained for the required period (2 years for most, longer for certain products) and accessible for FDA review.
How a pack is built
Intake to specialist release, with deterministic gates the AI cannot overrule.
AI extracts and drafts. Deterministic rules — running as code, outside the model — decide what is complete. A human specialist signs every release. That order is never reversed.
01
Compliance Gap Scan
Upload your product list and current recordkeeping. We return a free completeness read: which KDEs, CTEs, and plan elements you already have, and which are missing.
02
FTL classification & lot-code scheme
We classify each product against the Food Traceability List and design a traceability lot-code architecture that works across your supply chain.
03
Grounded drafting
The traceability plan, KDE templates, and lot-code assignment rules are drafted from your validated data and the 21 CFR 1 Subpart S rule pack into field-locked templates — no legal opinions, no invented facts.
04
Deterministic completeness gates
KDEs reconcile to the FTL product category; the 24-hour production window is verified; the plan checklist is resolved; any missing element blocks release.
05
Specialist release
A food-safety specialist reviews the exception queue and signs the release. High-risk or complex supply chains route to attorney review first.
06
Delivery
You receive the pack: traceability plan, lot-code scheme, KDE capture templates, evidence log, and the 24-hour FDA-ready spreadsheet — ready for your team to implement.
The bar we hold
Rigor you can measure.
100%
Specialist-released
No pack ships without a human signature.
5 days
Standard SLA
From complete intake to released pack.
<1%
Critical-defect target
Tracked against a gold-standard pack library.
4
Lien-search sources
FTL · KDE schema · lot-code rules · plan checklist, every applicable file.
Why TraceReady
Built to be the most thorough option a food company has.
Documentation-complete, by design
The deliverable is completeness itself — every KDE, CTE, and plan element accounted for or explicitly exception-coded. Nothing is left implicit.
Deterministic, not vibes
The gates that decide completeness are code, not a model's opinion. A drafting error cannot slip past a regulatory requirement.
In its lane, on purpose
We prepare documentation and run recordkeeping as your clerical agent. We never give legal advice, contact your customers, or handle physical product.
Engagement
Flat fee, per released pack. No contingency, ever.
Simple, predictable, and aligned with a documentation standard — not a cut of any recovery.
- A free Compliance Gap Scan before you commit — see exactly what is missing.
- One flat fee per released Traceability Pack; disclosed pass-through search fees.
- Optional fixed-fee attorney review for complex or high-risk supply chains.
- Optional Ongoing Recordkeeping Add-on for managed KDE capture and 24-hour spreadsheet readiness.
FAQ
Questions, answered precisely.
Is TraceReady a law firm?
No. TraceReady, a service of Your Deputy, Obuke LLC, provides documentation-completeness services. It is not a law firm, does not provide legal advice, and does not represent you in any legal matter. Attorney review is available and recommended for complex or high-risk supply chains.
Do you contact my customers or handle physical product?
Never. TraceReady is not a food safety auditor and does not contact your customers or handle physical product. You remain the responsible party for all regulatory compliance and recordkeeping.
What makes a pack 'complete'?
Completeness is defined by the regulation: the traceability plan present, all KDEs captured at each CTE, lot codes assigned and linked, the 24-hour production capability verified, and FTL applicability documented. Deterministic gates enforce each one before release.
How fast is it?
The standard SLA is five business days from complete intake to a specialist-released pack. The free Gap Scan is returned much sooner and tells you exactly what is still needed.
How are you priced?
A flat fee per released pack, plus disclosed pass-through search costs. No contingency and no percentage of any recovered amount or sale proceeds.
See what's missing before it costs you a warning letter.
Start with a free Compliance Gap Scan. Send your product list and current recordkeeping and we'll return a completeness read against every subsection of 21 CFR 1 Subpart S.
Documentation-completeness service · not legal advice · you remain the responsible party.