FSMA 204 Compliance with V5 – Traceability Built for FDA Enforcement
V5 from SG Systems Global enables food producers, packers, and distributors to meet the recordkeeping requirements of FSMA 204 by capturing every KDE and CTE in real time. With FDA traceability deadlines approaching, V5 ensures you have the operational infrastructure to comply—without spreadsheets, missing lot codes, or siloed systems.
Through integrated MES, WMS, and QMS modules, V5 tracks ingredient intake, processing, packing, storage, and shipping—automatically generating digital records that align with FSMA 204’s KDE and traceability lot code mandates.
“FSMA 204 isn’t just a list of requirements. It’s a call for total traceability—and V5 delivers it.”
— Compliance Manager, Fresh Produce Distributor
KDEs & CTEs Captured in Real Time
FSMA 204 centers on Key Data Elements (KDEs) and Critical Tracking Events (CTEs)—and V5 is purpose-built to enforce and record them at every stage of the supply chain:
- Receiving CTE: Capture product identifiers, location, traceability lot codes, and supplier data at intake
- Transformation CTE: Record input lots, quantities, processing activities, and output traceability lots using V5 MES
- Packing CTE: Tie product, date, and lot code to packaging runs with full traceability at the SKU and label level
- Shipping CTE: Record destination, product ID, lot codes, and dates automatically through V5 WMS
- Traceability Plan: Generate digital traceability records with audit-ready structure aligned to FSMA 204 guidelines
Traceability Records That Withstand FDA Scrutiny
When the FDA asks for KDEs and traceability events, you’ll need more than spreadsheets. V5 gives you structured, exportable digital records that satisfy FSMA 204’s two-tier expectations:
- Instant access to receiving, processing, packing, and shipping data
- Traceability lot codes linked to every movement and transformation
- 4-eyes electronic signoff and timestamped user actions
- Full audit trail exportable within 24 hours per FDA requirement
- Custom reports mapped directly to FSMA 204 recordkeeping format
Every scan, every batch, and every shift contributes to a single source of truth—so traceability isn’t theoretical. It’s documented.
“We used to rely on paper and guesswork. V5 connects our receiving, batching, and shipping records with zero gaps.”
— Operations Director, Fresh Cut Facility
Built for Traceability from Start to Finish
V5 ensures KDE and CTE capture doesn’t interrupt your operations—it becomes part of them. The system enforces traceability events at every touchpoint:
- Receiving: Supplier validation, COA capture, barcode tagging, lot generation
- Processing: Batch execution with material linking, allergen checks, and transformation records
- Packing: SKU-to-lot linkage, dynamic label printing, QA signoff before release
- Storage: FIFO enforcement, inventory lot visibility, location-based tracking
- Shipping: Order-level traceability records with outbound verification
It’s all logged, locked, and linked—ready for retrieval at any moment.
Scalable, Flexible, FSMA-Ready
V5 scales with your business and adapts to the traceability framework you need—whether you’re just starting or managing global supply chains:
- Cloud or on-premise deployment
- ERP, LIMS, printer, scale, and PLC integration
- FSMA 204, 21 CFR Part 11, GFSI, and global compliance frameworks supported
- Modular rollout for phased adoption of MES, QMS, and WMS functions
- Trusted by produce packers, RTE food producers, seafood importers, and more
With V5, you’re not just ready for FSMA 204—you’re building traceability into the foundation of your operation.
Explore how each module supports FSMA 204 conformance:
