The Complete ERP for FDA-Regulated Manufacturing & Distribution
One platform for manufacturers, co-packers, and distributors of food, supplements, and cosmetics. 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 and outbound distribution — manage your entire operation with full regulatory traceability.
Everything a regulated manufacturer or distributor 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
- Integrated accounting that ties the books to the floor — invoices, payments, inventory value, and COGS stay in sync automatically, with QuickBooks-ready exports
Ten 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, OOS investigations, 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, warehouse bin locations, pick/pack/ship workflows, sales orders, and shipment tracking.
Post-Market Surveillance
Adverse event reporting, complaint trending, product holds, market withdrawals, returns processing, and regulatory notification management.
Accounting & Finance
Full double-entry accounting built in: AR/AP aging, invoicing, general ledger, financial statements, budgets, bank reconciliation, and e-signed period close. Receiving, production, and shipping post to the books automatically — with QuickBooks-ready exports.
Documents & Controlled Records
SOP library with built-in SOP builder, versioned document control, custom log types, and a tamper-evident audit trail behind every record.
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.
Receiving mints the lot in quarantine, captures the COA and supplier linkage, and applies your sampling plan — nothing reaches production by accident.
QC Tested & Released
Identity, purity, and spec testing per ingredient SOP.
Results record against the ingredient specification; release is an e-signed QC decision with the reason captured, and out-of-spec results route to an OOS investigation.
Production Order
BPR opened, formulation scaled, materials issued.
The batch record generates from the master formulation with quantities scaled to batch size; material issuance draws FEFO from released lots only.
In-Process Controls
CCPs monitored, weights verified, deviations logged.
CCP and in-process checks record in-line on the batch record, with second-person verification captured where your SOPs require it.
QA Disposition
Finished-product test reviewed, batch record signed.
Batch review brings deviations, in-process checks, and test results into one disposition view; release is an e-signed decision with the full context attached.
Release & Ship
Lot released, COA generated, shipment recorded.
The finished lot enters sellable inventory, shipment documents generate, and the books post automatically — traceable forward to every customer it ships to.
post-market surveillance, complaint trending, recalls, annual product review, training records, and more
60+ modules across 13 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.