The Complete ERP for FDA-Regulated Manufacturing
One platform for food, supplement, and cosmetics manufacturers. Built around 21 CFR Part 111, Part 117, and Part 11 — with electronic records and e-signatures in 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 the records, signatures, and traceability you need for compliance are there by default.
- 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
Eight capability areas, one platform
From raw material receiving through release and post-market — covered by modules built for the regulatory load.
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.
A typical batch, end to end
A simplified slice of the regulatory chain — every step writes to the audit trail, with electronic signatures where they matter.
Lot Received
Material received, quarantined, COA on file.
QC Tested & Released
Identity, purity, and spec testing per ingredient SOP.
Production Order
BPR opened, formulation scaled, materials issued.
In-Process Controls
CCPs monitored, weights verified, deviations logged.
QA Disposition
Finished-product test reviewed, batch record signed.
Release & Ship
Lot released, COA generated, shipment recorded.
post-market surveillance, complaint trending, recalls, annual product review, training records, and more
50+ modules across 12 categories
Every aspect of the operation has its own module — production, quality, documents, MRP, post-market — and they all share one audit trail.
See it for your facility
A walkthrough scoped to what you actually make — supplements, food, cosmetics, or a mix.
Request a demo or ask for a custom quote
Share your production scale, ingredient categories, and which regulatory framework you operate under. The walkthrough will follow whatever workflow you spend most time in.
Get a Quote
Goes straight to Daniel — typically a reply within one business day.