Enterprise FSMA 204 traceability software for multi-plant batch compliance
Built for high-volume food, beverage, supplement, and chemical manufacturers. Complete Critical Tracking Event (CTE) and Key Data Element (KDE) records, multi-facility lot genealogy, and automated 24-hour electronic FDA reporting.
Enterprise-Grade Traceability Built into Operation Workflow
From inbound raw material intake across multiple facilities to work-in-progress transformation and high-volume customer distribution.
Automated CTE & KDE Record Creation
Capture receiving, transformation, and shipping events directly at point-of-work without manual double-entry or post-production record assembly.
Multi-Site Lot Genealogy
Track materials seamlessly across multiple manufacturing plants, co-packers, and distribution centers with unified traceability lot codes.
Bi-Directional Tracing in Seconds
Instantly execute forward tracing from raw ingredient lots to finished goods shipments, and backward tracing from end-customer deliveries to vendor origins.
Mandatory 24-Hour FDA Electronic Export
Generate pre-formatted, sortable electronic spreadsheets matching exact FDA specs on demand during inspections or audit windows.
Scan-First Warehouse & Shop Floor Automation
Enforce FEFO/FIFO consumption rules, lot-level hold/quarantine status, and barcode validation via native iOS/Android apps and industrial scanners.
Open System Interoperability
Integrate with QuickBooks Online, e-commerce channels (Shopify, WooCommerce, BigCommerce), cannabis compliance systems (Metrc, LeafLink), and your own pipelines through a REST API and outbound webhooks.
Enterprise Operational Impact
Instant Audit & Mock Recall Readiness
Transform recall preparation from a week-long multi-person crisis into a sub-minute automated report.
Narrowed Recall Exposure
Precise, immutable lot records isolate affected batch runs, preventing multi-million dollar blanket inventory destruction.
Enterprise-Grade Security & Isolation
Built on dedicated multi-tenant database isolation, robust audit logs, and granular role-based access controls for enterprise compliance.
Frequently asked
Is Zelviq suitable for multi-plant manufacturers?+
Yes. The Enterprise plan adds multi-facility warehousing and a dedicated database per customer, with role-based access and an open REST API for the systems already in the plant.
What critical tracking events (CTEs) does Zelviq capture?+
Zelviq records all primary FSMA 204 critical tracking events—including Inbound Receiving, Internal Transformation (Work Orders/BOMs), Shipping/Outbound Distribution, and Material Adjustments—complete with mandatory Key Data Elements (KDEs).
Does Zelviq integrate with our existing software?+
Zelviq ships connectors for QuickBooks Online, Shopify, WooCommerce, BigCommerce, Metrc, and LeafLink, plus a REST API and outbound webhooks for custom ERP and WMS integrations.
How fast can a trace report be produced during an FDA audit?+
In seconds. Forward and backward trace reports, recall lists, and lot balances export to CSV and PDF straight from the platform.
Does software alone guarantee FSMA 204 compliance?+
Compliance requires a comprehensive operational program covering people, vendor management, and standard operating procedures. Zelviq provides the automated, immutable record-keeping engine that guarantees your data is audit-ready on demand.
Schedule an Enterprise Traceability Demo
See how Zelviq automates FSMA 204 compliance across multi-site manufacturing environments. Request a tailored demonstration with our enterprise solution team.