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FDA Regulatory Compliance

By January 20, 2026, food and beverage businesses must be compliant with the FDA Food Traceability Final Rule.

It may seem far off, but considering the time required to secure full compliance, getting ahead of the curve is critical. So, don't hesitate, get started with a food ERP system that can help ensure your FDA compliance today.

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What Does the FDA Food Traceability Final Rule Mean for Your Business?

To ensure food safety, the FDA has established stricter traceability requirements for businesses that manufacture, process, pack or hold any food included on the Food Traceability List (FTL). The goal is to efficiently identify and remove potentially contaminated foods to prevent foodborne illness and death.

To do this, your business must maintain records containing applicable Key Data Elements (KDEs) that are associated with certain Critical Tracking Events (CTEs) and communicate the information as applicable to the FDA within 24 hours.

In the wake of the new Food Traceability Final Rule, food and beverage companies must implement the necessary technology and processes to ensure regulatory compliance well ahead of time. While the FDA’s goal is to “educate while they regulate” the penalties for noncompliance can lead to civil and potentially criminal action.

With the FDA's regulations evolving, compliance is non-negotiable. Now is the time to reassess your food traceability procedures and consider implementing a food and beverage ERP solution that helps you secure FDA compliance.

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Enter Aptean Food & Beverage ERP for Out-of-the-Box Compliance

Due to the many new terms, restrictions and demands within the FDA's guidelines, food traceability is about to become even more complex for your business. It's clear then that a paper-based, legacy or basic system will no longer cut it—your company simply has too many details and documents to capture and maintain.

Instead, you need a "single source of truth". You need a unified, digital platform to store and manage all this information, providing the necessary visibility for regulatory compliance and enabling the quick retrieval of data if an urgent food safety situation should occur.

With our food ERP system's standard functionality, your business can cover what's needed to be compliant with the FDA traceability rules "out of the box". From bi-directional ingredient tracking and quality hold management to allergen management and lot control, our software is built on decades of experience by food and beverage industry experts, ready to help with your regulatory compliance on day one.

If you're ready to get started on your journey to FDA compliance, get in touch with our experts today to discover how purpose-built food ERP can help.

Leverage Purpose-Built Software to Tackle Increased Traceability Requirements

In addition to providing a cross-functional digital platform and heightened operational visibility, advanced ERP software designed for the food industry can further streamline your compliance.

For example, Aptean Food & Beverage ERP allows you to integrate the system with your smart sensors, scales and imaging technology, as well as handheld barcode and QR code scanners. Not only does this automate data collection, but it also makes documenting all necessary KDEs at every CTE a simpler and quicker process—removing the possibility of human error and streamlining your compliance.

Choosing the right food and beverage ERP solution can boost your traceability efforts in two other key ways by automatically scheduling compliance checks and offering functionality to expedite 60-second recalls. With these features, you have more peace of mind that all critical steps in your tracking process are being performed correctly every time. Plus, you can quickly track contaminations back to the source and automate portions of the recall process.

At Aptean, we know the food industry inside-out, which means we've built our solutions with a deep understanding of the traceability challenges your business faces. Preparing your operations for these stricter standards should be a priority—it’s the right thing to do for your customers, as well as the longevity of your organization.

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Start increasing traceability in your operation

If you’re ready to take your food or beverage business to the next level, we’d love to help.

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