Stay Audit-Ready for FSMA 204

Stay Audit-Ready for FSMA 204 Compliance

FSMA 204 is transforming how food businesses in the United States approach food safety, documentation, and regulatory compliance. As part of the Food Safety Modernization Act (FSMA), and in alignment with the FSMA final rule, this regulation introduces enhanced food documentation and record-keeping requirements that demand speed, accuracy, accountability, and consistent preventive controls across the entire supply chain.

Paperless Forms supports FSMA compliance by providing a mobile-first, digital solution for structured data capture, offline form access, conditional logic, and audit-ready documentation—helping teams stay efficient, mitigate risk, and inspection-ready across food facilities. Our platform reinforces your food safety plan and integrates corrective actions, validation procedures, environmental monitoring, and digital signatures to meet evolving compliance expectations and FDA FSMA guidelines.

What is FSMA 204?

The FSMA 204 Final Rule mandates that all qualified facilities handling high-risk food products implement systems capable of capturing and reporting Key Data Elements (KDEs) and Critical Tracking Events (CTEs) within 24 hours. These food safety standards are part of a comprehensive food safety plan to reduce the risk of foodborne illness, contamination, and fraud.

This rule also reinforces the importance of technical assistance, preventive controls qualified individuals, and supplier verification programs. It aligns with the preventive controls rule, the produce safety rule, and the foreign supplier verification program to support public health, human consumption safety, and international trade.

It’s especially important for food facilities that work with foreign facilities or manage ingredients under GS1 US or Global Food Safety Initiative (GFSI) frameworks. Organizations must also consider critical control points, compliance dates, and how FSMA rules affect each food product category.

Ensure Food Safety Compliance

Stay audit-ready with automated record-keeping, digital audit trails, and real-time monitoring. Record and access Key Data Elements (KDEs) and Critical Tracking Events (CTEs) to meet 24-hour FDA response requirements. Support compliance with food safety standards and documentation for food safety plans.

Respond
Quickly

Easily trace the source of issues and act fast during food incidents to ensure swift and effective resolution. Ensure data accuracy with built-in validation, standardized forms, and automated checks for food defense and hazard analysis.

Increase
Performance

Digitize processes, capture data effortlessly, and collaborate in real time. Simplify data collection and management across your supply chain. Reduce human errors, make data entry easier, and access critical information quickly when you need it most.

Real-Time Data for Traceability

FSMA Challenge :

Businesses must document every movement of high-risk food through the supply chain to meet FSMA 204 traceability requirements and reduce food safety risks.

✔️ With Paperless Forms:

Fully customizable mobile forms
Real-time audit trails and live form status updates
Digital control sheets for traceability and compliance
Instant access to records in case of FDA inspections or audit emergencies
Built-in timestamps, user authentication, and validation for data integrity

Audit-Ready Compliance & Reporting

FSMA Challenge:

The FDA can request traceability records at any time, requiring businesses to respond within 24 hours with accurate, validated data.

✔️ With Paperless Forms:

Instantly generate and export FDA-compliant spreadsheets
Securely store records with version control and cloud backup
Centralized dashboards to support audit readiness, risk analysis, and compliance tracking
Export traceability data formatted for regulatory and third-party certifications
Track corrective actions and link them to food safety hazards or inspections

Eliminate Errors & Lost Records

FSMA Challenge:

Manual documentation processes can lead to compliance gaps, data errors, and missing records.

✔️ With Paperless Forms:

Mobile forms with built-in validation and automated error checks
Smart search and retrieval by keyword, date, product, or foreign supplier
Standardized forms to improve consistency and minimize human error
Eliminate documentation risks and strengthen food safety plans with preventive measures
Ensure real-time documentation of sanitation procedures and food safety controls

End-to-End FSMA 204 Compliance

FSMA Challenge:

Achieving data traceability across multi-site operations is complex, especially when coordinating preventive controls, documentation, and food safety plan elements.

✔️ With Paperless Forms:

Standardize compliance workflows across teams and facilities
Share real-time updates with QA, ERP, and supply chain systems
Ensure data integrity throughout the traceability process
Support sanitary transportation and foreign supplier compliance documentation
Enforce consistent food safety and risk mitigation practices across all locations
Track environmental monitoring activities, sanitation checks, food defense tasks, and verification steps

Paperless Forms

Capturer les données avec précision tout en maintenant la conformité aux exigences HACCP et GSFI.

Simple.

Sécurisé.

Solution novatrice.

Get Audit-Ready for FSMA 204

FSMA 204 requires enhanced traceability to ensure food safety throughout the supply chain. By adopting Paperless Forms, you can easily meet these regulatory requirements, simplifying the tracking and documentation process. This not only streamlines compliance with FSMA 204, but also improves overall safety, reduces the risk of errors, and enables your team to identify and address potential issues before they escalate.

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Digital Compliance for Food & Bev Industries

Stay Compliant

Record and access Key Data Elements (KDEs) and Critical Tracking Events (CTEs) to meet 24-hour FDA response requirements.

Streamline Operations

Simplify data collection and management across your supply chain. Reduce human errors, make data entry easier, and access critical information quickly when you need it most.

Respond Quickly

Easily trace the source of issues and act fast during food incidents to ensure swift and effective resolution.

Protect Your Brand

Build trust with proactive compliance, safeguard your reputation, and demonstrate unwavering commitment to consumer safety.

SMART TOOLS FOR AGRI-FOOD LEADERS

Paperless Forms

Create, collect, and analyze data easily with a mobile-friendly app.

Accessible on any device
Cloud-based for real-time compliance with HACCP and GFSI

Learn more

Supplyline

Simplifly supplier management with this web-based platform.

No installations required
Manage documentation and approval decisions with ease

Learn more

Documentation
Errors

Automated entries reduce human errors and support accurate mitigation strategies.

Audit
Pressure

Be audit-ready at all times with pre-configured reports and digital archives.

Cross-Site
Confusion

Standardize compliance efforts across food safety facilities and regions.

Inconsistent Data Collection

Customize and standardize forms across teams to ensure uniformity in data capture.

Lack of Real-Time Visibility

Get live form status updates and centralized dashboards to monitor compliance activities as they happen.

Slow Inspection
Readiness

Instantly access reports, logs, and records to respond to FDA audits within required timelines.

FSMA Compliance: Why It Matters

Food processors and manufacturers are under growing pressure to meet FSMA 204 and broader FSMA requirements. These include:

Meeting compliance dates and audit timelines for each food facility
Documenting critical control points (CCPs) and corrective actions
Verifying foreign supplier and foreign facility documentation
Preparing for third-party audits or accredited third party certification programs

Paperless Forms makes it easy to manage SOPs, compliance documentation, and sanitation checklists. You can centralize reports, automate validation, track training for preventive controls qualified individuals, and stay ahead of upcoming events and inspection requirements.

Food Processing Facilities

Produce Suppliers and Distributors

Food Manufacturers

Qualified Facilities and Foreign Suppliers

Multi-site Operations Needing Standardized Compliance Reporting

Businesses Involved in Food Recall Prevention, Mitigation and Response

Built for the Future of Food Safety

SMA 204 is just one element of a larger framework of food safety modernization. Businesses must also consider hazard analysis, preventive controls, food defense plans, food fraud prevention, environmental monitoring, good manufacturing practices (GMP), and potential third-party certification. Paperless Forms supports these practices and enhances readiness.

Paperless Forms helps ensure you're prepared—whether facing a routine inspection, responding to a recall, preparing for third-party audits, conducting root cause analysis, tracking food safety training, or building a food safety culture that evolves with regulation.

Having Datahex by our side ensures we are professionally represented to our customers while delivering exceptional quality service. They stay ahead of new HACCP/GFSI standards, all while helping us maintain our operating budget.

— Exceldor

At Olymel, we are thrilled with the exceptional services provided by Datahex. Their technical expertise, paired with outstanding customer support, has significantly optimized our operations. The dedicated team understood our needs perfectly and delivered solutions that exceeded all expectations. We wholeheartedly recommend Datahex to any company seeking to enhance their processes with innovative and reliable solutions.

— Olymel

I sincerely thank Datahex for their outstanding collaboration in implementing our HACCP/GFSI (SQF) system. Their team demonstrated exceptional efficiency at every level, making the process seamless. I wouldn’t hesitate to work with them again in the future.

— Plaisirs gastronomiques