Achieve FSMA 204 Compliance with Reserva:

A Complete Traceability Solution 

 

The Food Safety Modernization Act (FSMA) 204 requires businesses in the produce industry to implement rigorous traceability measures to enhance food safety and supply chain transparency. Achieving compliance involves detailed tracking of Critical Tracking Events (CTEs) and Key Data Elements (KDEs), ensuring accurate record-keeping, standardized labeling, and seamless recall management. Reserva ERP offers a comprehensive solution, integrating advanced traceability features to help businesses meet FSMA 204 requirements efficiently while improving overall operational performance. 

Critical Tracking Events (CTEs) and Key Data Elements (KDEs) 

- Lot-level tracking:
Capture detailed records at every critical point, from harvest to final distribution.

- Time-stamped events:
Accurately record date, time, and location for harvest, cooling, packing, processing, storage, shipping, receiving, and disposal events.

 

Reserva's robust traceability and lot tracking capabilities meticulously captures lot-specific details at every critical stage, including harvesting, packing, shipping, receiving, processing, storage, and disposal. By tracking detailed timestamps, locations, responsible parties, and product conditions, businesses can maintain transparency and quickly identify the complete journey of any produce lot, ensuring robust traceability and compliance. 
 

 

Reserva ensures automatic, secure storage of all necessary records in a centralized, electronic format, allowing immediate access within the FDA-mandated 24-hour response period. Comprehensive audit trails facilitate traceability for regulatory inquiries and audits, significantly simplifying the compliance verification process. 

 

Integrated Record Keeping 

- Electronic Record Maintenance:
Automatically capture and securely store records, accessible on-demand by FDA inspectors within the mandated 24-hour response window.

- Audit Trail:
A clear audit trail for all product movements, adjustments, and handling across the supply chain.

 

Standardized Labeling and Barcoding 

- GTIN & PTI Labeling:
Support standard Produce Traceability Initiative (PTI) labels, Global Trade Item Number (GTIN) barcode scanning, and integration with mobile devices or handheld scanners.

- Automated Label Printing:
Generate accurate, compliant labels at multiple stages (pallets, cases, and consumer units).

 

Reserva generates accurate, FSMA-compliant labels (including pallets, cases, and individual units), complete with essential product information and traceability codes. This automated labeling reduces human error and ensures adherence to regulatory standards. Additionally, Reserva provides real-time inventory visibility across the supply chain, significantly reducing risks associated with manual data entry and improving overall inventory accuracy.

Reserva's real-time inventory management provides detailed visibility into product sources, locations, handling procedures, and product conditions, ensuring accuracy and enhancing operational efficiency. This real-time insight enables proactive inventory management and risk mitigation, ensuring regulatory compliance and reducing operational disruptions. 

 

Comprehensive Inventory Management 

- Real-Time Inventory:
Track inventory movements and provide visibility across the entire supply chain, including detailed data on produce sources and handling methods.

- Location-Based Inventory:
Capture specific data at each location (warehouse, facility, or vehicle) handling the produce.

 

Supplier and Grower Management 

- Grower Onboarding and Documentation:
Detailed records and verification of supplier (grower) data, including certifications and growing practices.

- Integrated Supplier Reports:
Detailed supplier documentation, facilitating transparency and ensuring regulatory compliance.

 

Reserva's Supplier and Grower Management solution simplifies the complex task of managing relationships and compliance within your supply chain. By providing a centralized platform to onboard, verify, and maintain detailed supplier records, Reserva ensures seamless traceability and regulatory compliance aligned with FSMA 204 standards. Efficiently manage grower certifications, product sourcing, and quality control—reducing risk, improving transparency, and strengthening supplier relationships.

Reserva simplifies regulatory compliance by enabling rapid generation of FSMA-compliant traceability reports. Businesses can efficiently respond to FDA audits by promptly providing detailed, accurate, and easy-to-understand traceability data. This ensures regulatory compliance and reduces the administrative burden associated with audits.

 

Reporting and FDA Audit Readiness

- FDA-Compliant Reports:
Quickly generate traceability reports to meet FSMA 204 standards, identifying the complete journey of any produce lot within minutes.

- Online Portal Access:
Allow secure online access for regulatory authorities, internal auditors, or quality assurance staff to review or extract compliance records.

 

Recall Management

- Rapid Recall Capability:
Quickly identify and isolate affected produce lots, ensuring fast communication to stakeholders and regulatory bodies.

- Communication Automation:
Automatic notifications and status updates across the distribution network, minimizing impact during recalls or safety incidents.

 

In case of recalls or safety incidents, Reserva facilitates rapid, precise traceability to quickly identify affected lots and their exact locations within the supply chain. The system supports seamless communication and coordination across stakeholders, significantly minimizing operational disruptions and protecting brand reputation.

Reserva ERP seamlessly integrates quality inspection records, test results, and relevant certifications (such as HACCP and GAP) directly into traceability data. This integration ensures continuous adherence to stringent food safety standards and significantly enhances overall operational excellence by embedding compliance directly into day-to-day processes. Reserva integrates FSMA compliance with existing food safety certifications, including HACCP and GAP, through automated quality inspections embedded within the traceability records. This feature promotes consistent adherence to regulatory standards and ensures product quality throughout the supply chain. 

 

Quality Control and Compliance Integration 

- Food Safety Compliance:
Integration of FSMA 204 traceability features with existing compliance modules, such as HACCP and GAP certifications.

- Automated Quality Checks:
Documentation and recording of quality inspections integrated within traceability records.

 

Protect consumers, enhance supply chain visibility, and streamline operations with real-time tracking, automated record-keeping, and integrated quality control.