About the FSMA Final Rule

The FSMA (Food Safety Modernization Act) Final Rule establishes new traceability recordkeeping requirements for anyone who manufactures, processes, packs or holds foods on the Food Traceability List (FTL). These requirements aim to speed up the identification and removal of contaminated food from the market, reducing foodborne illnesses and deaths.

A key requirement is for these entities to maintain records with Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs) and provide this information to the FDA within 24 hours or within a reasonable time agreed upon by the FDA.

FSMA Rule 204 affects all entities in the food supply chain, including:

Food manufacturers
Processors
Packagers
Distributors
Retailers

All entities must comply with the recordkeeping requirements by July 2028.

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How DocStudio Helps Businesses to Comply with the FSMA Final Rule

Automated KDE Collection & Integration – Captures Key Data Elements (KDEs) directly from supply chain transactions, documents, and other sources, ensuring accurate and complete traceability.

EDI & Web-Based Document Exchange – Facilitates electronic exchange of invoices, purchase orders, ASNs, and other supply chain documents via EDI or a user-friendly web interface, ensuring seamless communication with suppliers and distributors.

Structured Data Storage & FDA-Ready Formatting – Stores KDEs in a structured format that can be easily converted into any FDA-required format, enabling efficient data retrieval and compliance.

Audit-Ready Document Management

Reporting & Compliance Tracking – Logs and timestamps traceability events, providing automated reports and full visibility to meet FDA audit requirements.

Real-Time Supply Chain Compliance – Ensures suppliers and distributors maintain accurate, standardized traceability records, reducing errors and improving response times.

24-Hour FDA Response Readiness – Enables quick generation and submission of traceability records within 24 hours of an FDA request.

Seamless IT Integration – Connects with existing ERP, WMS, and other IT systems to automate KDE collection and eliminate manual data entry.

Benefits of DocStudio’s AI Document Recognition

Automate Compliance Tasks

Reduce manual work by capturing and processing data instantly.

Eliminate Human Errors

AI-powered recognition ensures accurate and reliable recordkeeping.

Seamless System Integration

Sync traceability data with your existing ERP, WMS, and compliance systems.

Scale with Your Business

Manage any volume of documents with high-speed processing and API access.

Data Accuracy, Security, and Compliance

At DocStudio, we understand the importance of data security and compliance. As we have processed more than 800,000,000 documents, we take our responsibility to protect our customers' data very seriously. That's why we have implemented industry-leading security and compliance standards to ensure that your documents are safe when you create, sign, send, and store them with us. These standards are defined in the US, Europe, and around the world, so you can trust that your data is being handled in a way that meets the highest standards of security and compliance.

We are certified to the rigorous international security standards for information security management systems (ISMS), ISO/IEC 27001:2013, and ISO/IEC 27018:2019. Additionally, our platform complies with HIPAA and GDPR regulations to protect your data. With these certifications and compliance measures in place, you can have peace of mind knowing your data is secure with us.