The Complete ERP for FDA-Regulated Manufacturing
One platform for food, supplement, and cosmetics manufacturing. 21 CFR Part 111, Part 117, and Part 11 compliance built into every module.
One platform, complete control
From raw material receiving to finished goods release — manage your entire manufacturing operation with full regulatory traceability.
Everything a regulated manufacturer needs, in one place
Culextion GMP eliminates the patchwork of spreadsheets, paper logs, and disconnected tools. Every workflow is designed around the regulations you must follow — so compliance is automatic, not an afterthought.
- Complete batch production records with in-process checks, QC sampling, and disposition workflows
- Formulation management with batch scaling, allergen tracking, and cost-of-goods calculation
- Full quality system: CAPA, deviations, change control, self-audit checklists, and complaint handling
- 21 CFR Part 11 electronic signatures with tamper-proof audit trail and role-based access control
Everything you need, nothing you don't
Eight core capability areas covering the full lifecycle of FDA-regulated manufacturing operations.
Formulation & BOM
Recipe management with batch scaling, ingredient specifications, allergen tracking, and cost-of-goods calculation.
Batch Records & Release
Production orders with full batch records, QC sampling, in-process checks, disposition workflows, and batch release.
Quality System
CAPA workflows, deviation management, change control, self-audit checklists, complaint handling, and recall management.
Supplier Qualification
Vendor approval workflows, COA management, audit scheduling, re-qualification tracking, and approved supplier lists.
MRP & Procurement
Material requirements planning, purchase orders, receiving inspection, reorder points, and FEFO enforcement.
R&D Lab & Supplement Facts
NDI tracking, structure/function claims, supplement facts panel generation, stability testing, and formula versioning.
Warehouse & Fulfillment
Five-tier inventory, lot traceability, pick/pack/ship workflows, sales orders, invoicing, and shipment tracking.
Post-Market Surveillance
Adverse event reporting, complaint trending, product holds, market withdrawals, and regulatory notification management.
50+ modules across 12 categories
Every aspect of your manufacturing operation covered by purpose-built modules designed for regulatory compliance.
Ready to modernize your operation?
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Tell us about your facility, your production scale, and your compliance requirements — and we'll tailor a proposal specific to your operation. No generic pitches, just real solutions.
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