Built for FSMA 204

FSMA 204 Compliance, Built for You

RegEngine pairs an API-first architecture with published pricing and a self-serve onboarding path designed to get your first FSMA 204 export ready for review in days, not months.

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Six Reasons Teams Choose RegEngine

We built RegEngine for technical teams, ops managers, and founders who need compliance fast without compromise.

API-First Architecture

CSV upload and the JSON events API. Integrate RegEngine with your existing ERP, WMS, or custom systems through those two live paths. No rip-and-replace required.

Technical teams can be live in hours. Sales ops teams use our CSV templates. Everyone gets FSMA 204 compliance their way.

Transparent Pricing

No hidden sales calls. Founding rate plans start at $425/mo (billed annually). Pricing is published, so you do not need to "contact sales."

Compare directly to competitors who make you "contact sales." We believe pricing transparency builds trust and moves faster.

Self-serve, days not months

Get from signup to a first FSMA 204 export in days. CSV upload or API payload → validation → export. No 3 to 6 month enterprise implementation.

Major retailers and FDA enforcement deadlines arrive on calendar dates; teams ship sooner when the platform is self-serve.

Full CTE/KDE Coverage

All 7 FSMA 204 CTE types. Per-CTE KDE validation (not batch). Incomplete CTEs are a common gap teams discover during recall drills.

Every field in every CTE type is validated individually so gaps are visible before you submit.

EPCIS 2.0 export (Preview)

EPCIS 2.0 (Preview) export for trading-partner interoperability. Verify each enabled workflow against your retailer and buyer requirements.

We started on EPCIS 2.0; verify EPCIS coverage with each vendor for your stack.

Built for SMBs

Not enterprise-only. Small produce distributors, regional suppliers, emerging brands. Self-serve signup, no minimum spend.

You don't need a 50-person implementation team. You need FSMA 204 compliance fast, cheaply, and without bureaucracy.

Feature-by-Feature Comparison

See how RegEngine stacks up against the industry standard and legacy competitors.

Feature	RegEngine	Trustwell	SafetyChain	ReposiTrak
CSV upload + JSON events API	Yes	No	No	No
Transparent, Published Pricing	List price from $849/mo (partner rates from $425/mo)	Contact sales	Contact sales	Contact sales
Time to first export	Days (self-serve)	Sales-led implementation	Sales-led implementation	Retailer-coordinated
All 7 FSMA 204 CTE Types	Full coverage	Verify with vendor	Verify with vendor	Verify with vendor
EPCIS 2.0 export (Preview)	Yes	Verify with vendor	Verify with vendor	Verify with vendor
CSV Import + Mapping	Yes	Yes	Yes	Yes
Works with Existing ERP/WMS	By design	Verify with vendor	Verify with vendor	Verify with vendor
Self-Serve Onboarding	Yes	Sales-led	Sales-led	Retailer-mediated
Per-CTE KDE Validation	Yes	Verify with vendor	Verify with vendor	Verify with vendor
FDA-Oriented Sortable Export	Yes	Yes	Yes	Yes
Recall Drill Workflows	Yes	Yes	Yes	No
No Multi-Year Lock-In	Yes	No	No	No

Note: Comparison data is based on public pricing and vendor documentation as of April 2026. Competitor features change; if you spot an error, email support@regengine.co.

API-First, Not UI-Only

REST endpoints, CSV templates for ops teams, and outbound webhooks for FDA recall/enforcement alerts (enabled by RegEngine). API coverage for every feature is on the roadmap. Your developers can integrate in hours, not months.

RegEngine started with APIs and added the dashboard on top, so every dashboard action is reachable programmatically. Verify API surface depth with each vendor for your stack.

Full REST API for CTEs, suppliers, compliance status
Outbound webhooks for FDA recall/enforcement alerts (enabled by RegEngine); broader compliance alerts on the roadmap
CSV import with smart field mapping
Native integrations with Shopify, WooCommerce (coming soon)

POST /api/ctes
Content-Type: application/json

{
  "traceability_lot_code": "<your lot code>",
  "product": "<product description>",
  "supplier_gln": "<13-digit GLN>",
  "received_date": "<YYYY-MM-DD>",
  "location_gln": "<13-digit GLN>"
}

HTTP 201
{
  "cte_id": "<generated id>",
  "status": "validated",
  "missing_kdes": []
}

Base Plan

$425/mo $849/mo

Founding rate, billed annually ($499/mo monthly) • 1 facility • 500 CTEs/mo

Standard Plan

$549/mo $1,099/mo

Founding rate, billed annually ($649/mo monthly) • 2 to 3 facilities • Unlimited CTEs

Premium Plan

$639/mo $1,275/mo

Founding rate, billed annually ($749/mo monthly) • 4+ facilities • Dedicated support

Pricing You Can See Before You Sign

Open pricing builds trust. We list prices on our website. No "contact sales" gatekeeping. No surprise enterprise minimums.

The Founding rate is preferred pricing for the life of your account. Plans start at $425/mo (billed annually) or $499/mo monthly. Honest pricing for honest work.

Simple design-partner agreements with no multi-year lock-in
API access for contracted workspaces
Founding Design Partner rate never increases

Self-serve onboarding, days not months

When a deadline approaches, every week matters. RegEngine takes teams from signup to mapped supplier data and retailer-readiness review in days. Once records are mapped, FSMA-formatted exports build in minutes.

Sales-led platforms typically run multi-month implementations. Verify timelines with each vendor.

Upload your CTEs (CSV or API)

RegEngine validates all KDEs

Export §1.1455-formatted trace data

Onboarding model

Self-serve

RegEngine

Sales-led

Trustwell, SafetyChain (per their public materials)

Retailer-coordinated

ReposiTrak (per their public materials)

Competitors named are trademarks of their respective owners. Verify current onboarding timelines directly with each vendor.

All 7 FSMA 204 CTE Types

Harvesting

Cooling

Initial Packing

First Land-Based Receiving

Shipping

Receiving

Transformation

Complete CTE/KDE Coverage

All 7 FSMA 204 CTE types, fully implemented. Every field validated individually (not batch). Incomplete CTEs are a common gap teams discover during recall drills.

Verify CTE coverage and validation depth with each vendor for your stack. RegEngine covers all 7 with per-CTE KDE validation that surfaces errors before submission.

Per-CTE key data element validation
Supplier relationship mapping across all CTEs
Location traceability from source to receiver
FDA 204 naming conventions built in

EPCIS 2.0 export (Preview)

EPCIS 2.0 (Preview) can support trading-partner interoperability. RegEngine treats EPCIS 2.0 as a preview schema where the enabled workflow and source data allow it.

Verify EPCIS coverage with each vendor; some platforms layer EPCIS over legacy schemas, which can introduce conversion edges.

EPCIS 2.0 XML + JSON serialization (Preview)
Traceability event export support
No third-party conversion needed
Designed for buyer and trading-partner interoperability checks

<events>
  <EPCISEvent>
    <eventTime><event timestamp></eventTime>
    <eventType>
      ObjectEvent
    </eventType>
    <epcList>
      <epc>
        urn:epc:id:sgtin:...
      </epc>
    </epcList>
    <action>OBSERVE</action>
    <bizStep>
      urn:epcglobal:cbv:bizstep:...
    </bizStep>
  </EPCISEvent>
</events>

RegEngine is built for companies like:

Regional produce distributors ($5M to $50M annual revenue)
Specialty food brands and co-packers
Organic/specialty retailers and wholesalers
Small farms and grower cooperatives
Emerging CPG brands reaching FDA compliance

Built for SMBs, Not Enterprises Only

Compliance shouldn't require a 50-person implementation team. You need FSMA 204 compliance, fast and cheap. Self-serve signup, no minimums, no sales calls.

Legacy platforms built for 100+ facility enterprises. RegEngine scales from 1 to 1,000 facilities. You start small; you grow without ripping out the platform.

Self-serve signup with onboarding support when needed
No implementation services required
Scales from 1 to 1,000 facilities
Direct support channel based on plan and rollout scope

What RegEngine Is NOT

RegEngine is a compliance layer, not a replacement for your ERP or WMS. We work alongside your existing systems, filling the traceability gaps that packaged software doesn't solve.

We are NOT an ERP replacement

Your inventory, financials, and order management stay in Shopify, NetSuite, or QuickBooks. RegEngine handles traceability.

We are NOT a supply chain analytics platform

We focus on advisory compliance validation and FDA-oriented sortable exports. Advanced forecasting and sourcing tools live elsewhere.

We do NOT promise 100% FDA audit success

Compliance is a process, not a product. We validate data and generate FDA exports. Audits require auditors.

We do NOT lock you in

Simple design-partner agreements with no multi-year lock-in. Export all your data anytime. Your data is yours.

Who's RegEngine For?

If you fit any of these categories, RegEngine is built for you.

Technical Buyers

Your team owns integrations. You want APIs, outbound webhooks for FDA recall/enforcement alerts (enabled by RegEngine), and source control. RegEngine gives you that.

Operations Teams

You need FSMA 204 compliance done quickly. CSV upload is fast enough. No custom dev needed.

Founders & SMBs

You need compliance but can't afford enterprise fees. Founding rates from $425/mo (billed annually) get you live. Scale as you grow.

Compliance Officers

You need per-CTE validation and FDA-oriented sortable exports. RegEngine gives you audit trails and supporting records.

Ready to Get Compliant?

Request access in minutes. Start with the onboarding path that fits your team. Simple design-partner agreements with no multi-year lock-in.

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Questions? Email support@regengine.co for rollout or integration questions.