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Manage Every Rule
Proactively With End-to-End
FSMA Compliance Software

Track and analyze food safety performance metrics in alignment with FSMA’s current Good Manufacturing Practices (cGMP). Get purpose-built software to manage up-to-date FSMA compliance records for audits and inspections.

dashboard screen of FSMA compliance software

Over Two Decades of Food Safety Leadership

Make FSMA Compliance Less of a Struggle

Keeping up with FSMA regulations can be time-consuming and error-prone. Simplify the process with a system that digitizes workflows and supports real-time audits.

Excessive Data Points Overwhelm Traceability Systems

Challenge

High SKU volumes and complex distribution chains generate overwhelming KDEs and CTEs, straining traceability infrastructure and risking noncompliance with FSMA 204.

Solutions
Challenge

Disorganized records and siloed systems make it difficult to electronically retrieve required data within the FDA’s strict 24-hour audit response timeframe.

Solutions
Challenge

Missing supplier verification documents or improper risk evaluations under FSVP can lead to FDA detentions and restricted market access for imports.

Solutions
Challenge

Non-aligned or outdated food safety plans violate FSMA’s Preventive Controls rule, risking operational shutdowns and exposing facilities to regulatory action.

Solutions
Challenge

Inaccurate allergen declarations, nutritional facts, or ingredient lists can cause FSMA labeling violations, product recalls, and potential consumer lawsuits.

Solutions
Challenge

Gaps in sanitation schedules or undocumented cleaning activities can undermine environmental controls, leading to inspection failures and potential enforcement actions.

Solutions
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Features Designed to Fulfill Every FSMA Rule

FSMA compliance software features enable end-to-end regulatory control from foreign supplier verification to CAPA management.

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Food Defense Management

Implement and track food defense plans, monitor facility access points, and document preventive actions against intentional contamination risks.

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HACCP & Food Safety Plan Builder

Generate and customize HACCP and food safety plans, assign critical control points (CCPs), and automate hazard analysis for compliance.

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Supplier Verification (FSVP)

Track and verify foreign suppliers, conduct risk assessments, and document compliance with FSMA’s Foreign Supplier Verification Program (FSVP).

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CTE & KDE Tracking

Capture and record Critical Tracking Events (CTEs), store Key Data Elements (KDEs), and enable lot-level traceability throughout production.

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Specification Management

Manage product specifications, including ingredients, allergens, and regulatory requirements, and ensure compliance by tracking specification changes.

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Labeling Compliance Tools

Generate and update compliant labels, ensuring accurate ingredient lists, nutritional information, and allergen declarations based on FDA standards.

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CAPA Management

Automatically create Corrective and Preventive Actions (CAPAs), track root causes, and assign tasks to ensure resolution of compliance issues.

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Non-Conformance Alerts

Instantly identify and receive alerts for non-conformances, allowing for swift documentation, investigation, and resolution within compliance workflows.

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Sanitation & Cleaning Monitoring

Record and monitor sanitation activities, schedule cleaning tasks, and track verification procedures to ensure FSMA cleanliness standards are met.

3 Steps to Keep Your Business FSMA-Compliant

Simplify FSMA regulatory compliance by centralizing critical data, enhancing traceability, and proactively managing all food safety risks.

Build FSMA-compliant Plan

Create a Preventive Controls-based food safety plan with defined hazards, CCPs, and mitigation procedures aligned with FSMA Part 117.

Monitor & Manage Compliance Risk

Track CCPs, CTEs, and KDEs in real time to identify deviations, enforce corrective actions, and maintain audit readiness.

Auto-generate Compliance Reports

Automatically compile and export FDA-ready records, monitoring logs, and verification reports to support inspections and traceability requirements.

Turning Roadblocks into Breakthroughs

See how we turn challenges into breakthrough solutions for our clients.

Leave No Food Safety Measure Unchecked

Achieve complete visibility and granular control over all food safety protocols and critical data points within every aspect of your food business operations.

Compliance Management

Manage FSMA, HACCP, and GFSI compliance proactively with automated tracking, trigger corrective actions, and maintain continuous audit readiness in real time.

Use Cases
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Quality Management

Enable dynamic quality control with statistical process control (SPC), non-conformance tracking, CAPA integration, and specification-based inspection checkpoints.

Use Cases
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Supplier Management

Digitally manage supplier approval, COAs, FSMA FSVP compliance, audit records, and risk profiles to ensure end-to-end sourcing integrity.

Use Cases
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Food Recall Management

Initiate recalls instantly, trace products by lot, identify root causes, and generate FSMA 204-compliant documentation using recall tracking software with FSMA compliance.

Use Cases
image of food recall management identifying contaminated batches

Ingredient Management

Monitor ingredient specifications, shelf life, allergen risks, and lot-level tracking while integrating vendor data for consistent formulation and compliance control.

Use Cases
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Recipe Management

Maintain validated formulations with yield factors, nutritional profiles, allergen mapping, and dynamic version control to ensure regulatory and label compliance.

Use Cases
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Food Traceability Software

Capture KDEs and CTEs in real time to enable FSMA 204-compliant traceability, contain incidents swiftly, and track products across every supply chain tier.

Use Cases
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Food Safety Documentation & Audits

Automate recordkeeping for SOPs, CCP monitoring, sanitation logs, and manage digital audit trails. Ensure compliance with CFR Title 21 and the GFSI scheme.

Use Cases
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Manage FSMA Compliance Without the Chaos

Integrate all the apps you use to manage your food processing business with FSMA compliance software, consolidating your entire operation into one platform.

In the Words of Our Clients

Read what our clients say about their experiences and the difference our solutions have made for them.

Frequently Asked Questions

What is FSMA compliance?

FSMA compliance refers to meeting the requirements set by the U.S. Food Safety Modernization Act. It focuses on preventing food safety issues rather than reacting to them. Facilities must implement measures like preventive controls, traceability, supplier verification, and recordkeeping to ensure food safety.

Failure to comply with FSMA 204 can lead to FDA inspections, warning letters, product recalls, import refusals, and facility shutdowns. Companies may also face significant financial loss and damage to brand credibility due to traceability violations or delayed data submission.

The software captures, organizes, and links KDEs and CTEs across the supply chain. It enables real-time traceability, automates recordkeeping, and ensures that all traceability data is readily retrievable within the FDA’s 24-hour requirement.

It centralizes supplier documents, tracks verification status, automates risk evaluations, and flags non-compliance. Tools for managing FSVP records, audit history, and corrective actions simplify supplier oversight and support FSMA adherence.

The software verifies allergen, ingredient, and nutritional data against regulatory standards. It also standardizes label templates, reduces manual errors, and automatically updates labeling information when formulations or regulations change.

It maps product movement across supply chain steps, records KDEs and CTEs, and links them to lot-level data. This ensures quick, accurate traceability to meet FSMA 204 traceability rule requirements.

The dashboard provides a centralized view of facility-wide compliance. It displays the real-time status of traceability documentation, food safety plan updates, supplier verification logs, and audit preparedness. The system flags missing KDEs and CTEs, alerts users of overdue actions, and highlights gaps in preventive controls. This allows teams to monitor FSMA readiness continuously and act proactively.

The software enables the identification of affected lots through detailed batch records and distribution logs. It auto-generates recall notices, tracks resolution steps, and stores all communications and documentation. Real-time alerts and audit trails ensure the recall process meets FDA reporting and corrective action requirements.

It audits your facility against FSMA rules by evaluating documentation, monitoring preventive controls, and checking training records. The system highlights non-conformities, assigns corrective tasks, and generates compliance scores and reports.

The software centralizes traceability documentation, allowing users to map supply chain flows, record supplier details, and define product movement. It supports real-time production, handling, and distribution tracking, aligning with FSMA 204 traceability rule requirements for high-risk food categories.

It organizes all food safety documentation, plans, logs, and supplier records in a centralized, searchable system. Built-in scheduling ensures timely audits and task reminders. Real-time dashboards and report generation make demonstrating compliance during unannounced inspections or FDA audits easy.

The software unifies data across multiple facilities, ensuring standardized food safety protocols and documentation. It enables real-time monitoring, making it easier to maintain consistent compliance and prepare for audits across all sites.

Serving the FoodTech Industry Globally Since 2004