Food Safety Modernization Act 204 | Velotic
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Food Safety Modernization Act 204

Software can be a key enabler to abiding by these regulations which is crucial for maintaining compliance and protecting public health.

FDA Food Transparency Let us help you meet the FSMA 204 requirements. Contact Us.

In January 2023, the FDA issued the Food Traceability Final Rule, requiring additional traceability records for manufacturers, processors, packers, and holders of foods on the Food Traceability List (FTL). While targeting higher-risk products, this rule will likely influence broader food supply chain practices. It mandates rapid identification and removal of contaminated food, reducing foodborne illness risks. Companies must record key data elements (KDEs) for critical tracking events (CTEs) and share information with FDA within 24 hours. The rule applies to domestic and foreign firms supplying the U.S. and requires full compliance across the supply chain by 2028.

Velotic software provides a comprehensive integrated approach to meet the requirements.

Regulatory agencies and retailers are raising requirements for preventative strategies, pushing food safety and quality programs to emphasize improved processing and quality initiatives. A holistic, integrated approach enhances production control and fosters collaboration among suppliers, producers, customers, regulators, and consumers. Leveraging real-time intelligence, analytics, standard practices, and traceability delivers deep operational insights, helping identify risks early. This enables proactive, real-time corrective actions when processes deviate, ensuring consistent food safety, high quality, and productivity gains across the production environment.

Quality Checks

The Future of Food Safety: Core Elements of FSMA 204 Compliance

End-to-end transparency with Proficy Smart Factory – With Proficy Smart Factory software, F&B companies can accurately document what happened during all phases of production to help ensure compliance with new and existing regulations and use this data for continuous process improvement. In addition, the software provides:

  • Holistic data collection and storage
  • A structured model – data in context (batch, product type, grade, etc.)
  • Enforced digitized work processes/SOPs
  • A complete collection of relevant data (for operational technology/information technology)

 

Quality Checks
Outcomes

Outcomes

End-to-end transparency with Velotic – With Velotic software, F&B companies can accurately document what happened during all phases of production to help ensure compliance with new and existing regulations and use this data for continuous process improvement.

Minimize food safety risks

Minimizing food safety risks requires a proactive, tech-driven approach. By enabling end-to-end traceability, utilizing AI-powered tools for rapid analysis, and fostering a strong food safety culture, organizations can prevent outbreaks, respond faster to recalls, and protect consumers effectively.

Quality

Enhance process control & consistency

Enhancing process control and consistency involves leveraging smarter tools, predictive analytics, and real-time data to streamline food safety operations. Strengthening root cause analysis and adopting modern inspection methods ensure uniform standards, reducing variability and improving outcomes.

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Improving OEE and quality with analytics

Improving OEE and quality with analytics means using advanced data tools to identify inefficiencies, predict issues, and optimize production. AI-driven insights boost equipment effectiveness, reduce downtime, and enhance product quality by enabling faster, data-backed decisions.

Clean out

Track and trace

Track and Trace leverages tech-enabled traceability to monitor products from farm to table. By capturing and analyzing data at every step, businesses can quickly address recalls, enhance food safety, and ensure compliance, while providing transparency and confidence to consumers.

Inventory and genealogy

Accurately document what happened during all phases of production To meet traceability requirements, it is important to have full knowledge of the origin and quantities of the materials flowing through the system, along with precise knowledge of when these materials were used in the process. Detailed documentation of material usage is particularly important when one lot of ingredients can flow to multiple batching systems over an extended period of production. •View genealogy links for serials/lots/batches with complete parent/child hierarchies represented •View details of each link (lot/serial) and where and when it is used
FSMA 204 Podcast Series

Manufacturing KnowHow: FSMA 204 podcast series

Episode 1 of 3

How does this new regulation affect you?

Industry leaders explain FSMA 204, the new FDA rule impacting all food manufacturers. The time to prepare is now. Click here to watch.

Episode 2 of 3

Food transparency and compliance with the FDA

FSMA 204 experts dive deeper into FDA rules and how MES helps food manufacturers boost compliance, traceability, and efficiency. Click here to watch.

Episode 3 of 3

MES supports sood safety & traceability

Integrate MES with ERP systems, generate FDA-required electronically sortable spreadsheets (ESS) and optimize processes for traceability. Click here to watch.
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White paper

  • Top 5 Software Capabilities for Ensuring Food Safety

    There’s a real opportunity for manufacturers to improve food safety during production with critical software capabilities that leverage real-time actionable knowledge and provide insight and analytics for enhanced control and consistency.

    White paper

  • Improving Process Transparency in Food and Beverage Manufacturing | Velotic

    In today’s manufacturing environment, traceability is imperative for avoiding and minimizing quality issues that can result in product recalls and harm to the brand equity. Even with detailed HACCP (hazard analysis critical control point) procedures and SOPs (standard operating procedures) in place, it can be difficult to monitor compliance. This white paper discusses and provides a customer case study of how digitalization leveraging electronic work process management can greatly improve traceability by digitizing and documenting both manual and automated processes—and ensuring compliance with HACCP procedures and SOPs.

    White paper

  • Everything you need to know about manufacturing execution systems

    White paper

  • Close the Productivity Gap with Overall Equipment Effectiveness (OEE)

    Discover how food & beverage and CPG manufacturers are using OEE to reduce downtime, improve quality, and increase throughput. Download the white paper to learn how.

    White paper Close the Productivity Gap with Overall Equipment Effectiveness (OEE)