Nutraceutical ERP software built for FDA 21 CFR Part 111, formula management, and full lot traceability

Nutraceutical ERP software is an enterprise resource planning system purpose-built for supplement and nutraceutical manufacturers. Unlike generic ERP, it includes industry-specific functionality such as FDA 21 CFR Part 111 cGMP compliance workflows, formula management with potency and overage tracking, lot traceability, and automated COA generation — all connected to finance, inventory, and production in a single platform.

inecta Food ERP includes a dedicated 21 CFR Part 111 module that captures all required cGMP documentation: batch production records, component examination and identity testing at receiving, in-process testing, finished product testing, and product release records. Hold-and-release workflows enforce cGMP requirements at each production stage. The system keeps every record organized and audit-ready at all times — without manual aggregation from spreadsheets or email.

DSHEA (the Dietary Supplement Health and Education Act of 1994) is the federal statute governing dietary supplements in the United States. It establishes the framework for label claims, New Dietary Ingredient (NDI) notifications, and manufacturer responsibility for product safety and substantiation. inecta Food ERP supports DSHEA compliance through label claim management tied to formulation data, NDI status tracking at the ingredient level, and a documented trail from formula specification through batch production and test results.

inecta Food ERP provides full forward and backward traceability across your entire supply chain. Every raw material lot, intermediate blend, and finished product is tracked from receipt through production, packaging, and shipment. Traceability meets both DSHEA and FSMA requirements for dietary supplements. In a recall scenario, you can identify all affected lots, customers, and shipments within minutes.

Potency tracking records active ingredient levels at each stage — from raw material receipt through finished product. Overage management is the practice of formulating with a calculated surplus of active ingredients to ensure label claims are still met at end of shelf life, accounting for natural degradation. inecta Food ERP includes potency and overage tracking as a purpose-built feature: the system stores overage percentages per active ingredient, incorporates them into every batch calculation, and verifies that each finished lot meets label claims at manufacture and through the stated shelf life. This is critical for DSHEA label claim substantiation.

Yes. inecta Food ERP supports multiple production models including contract manufacturing, private label, and branded product lines. You can manage customer-specific formulas, maintain separate quality specifications per customer or brand, and track costs and margins at the product, customer, and order level.

Generic ERP systems require expensive customization to handle nutraceutical-specific needs like potency and overage tracking, formula management with active ingredient calculations, FDA 21 CFR Part 111 cGMP compliance workflows, identity testing documentation, and automated COA generation. inecta Food ERP includes all of this out of the box — built by a team with 25+ years of food and beverage industry experience. There is no customization project required to make the system work for supplement manufacturing.