Operational excellence, from start to finish
ERP for food and supplement manufacturing, cosmetics production, and regulated agriculture — hosted on SOC-2 Type II infrastructure.
Choose your industry
A separate platform per industry — each one shaped by the specific regulations, workflows, and inspection patterns of that vertical.
Food & Supplement Manufacturing
Compliance-ready ERP for 21 CFR Part 111 & 117. Batch records, formulations, QC release, lot traceability, CAPA workflows, vendor qualification, and complete post-market surveillance.
Explore GMP PlatformCosmetics Manufacturing Coming Soon
For FDA-regulated cosmetics production under MoCRA. Formulation management, batch tracking, stability testing, adverse event reporting, and Part 11 e-records.
Learn MoreRegulated Agriculture
Seed-to-sale compliance for Illinois Craft Growers, Cultivation Centers, and Infusers. Planned METRC Integration, batch production records, six-tier inventory, and full regulatory inspection readiness.
Explore Agricultural PlatformWhy we built it this way
Every platform is designed around real regulatory requirements — not retrofitted from generic software.
Compliance-First Architecture
Modules mapped directly to FDA cGMP, Illinois 8 IAC 1300, METRC, and FSMA. Pre-built templates, CAPA workflows, deviation management, and inspection readiness dashboards.
Full Audit Trail & Electronic Records
21 CFR Part 11 electronic signatures, tamper-proof audit logs, role-based access control, and complete lot traceability. Every action recorded, every record attributable.
SOC-2 Type II Certified Infrastructure
AES-256 encryption, automatic backups, and zero local installs. Accessible anywhere, with 99.9% uptime and disaster recovery built in.
Continuous Regulatory Updates
FDA rule changes, state regulation updates, and operator-driven improvements deployed continuously. No upgrade fees, no migration headaches.
A few of the modules in production today
Built around the regulatory load, not the demo. The full platform spans well over a hundred modules across both products — here's a representative sample.
Batch Production Records
Auto-generated BPRs with FEFO enforcement, in-process QC sampling, weight checks, and disposition workflow tied to release.
Reason-Coded Signatures
Every release, override, and amendment captured with reason code, signer identity, and immutable audit trail entry.
Multi-Tier Inventory
Raw materials, intermediates, bulk, finished, packaging, and supplies — with lot traceability and reconciliation against state systems.
Deviations & CAPA
Deviation → root cause → CAPA → effectiveness verification, linked end-to-end with auto-spawning recurring tasks.
Supplier Qualification
Vendor approval workflow, COA management, audit scheduling, and re-qualification triggers tied to incoming lot acceptance.
And many more
R&D lab work, supplement facts panels, post-market surveillance, training records, equipment calibration, environmental monitoring, recall management, label generation, and beyond.
We understand your industry
Founded by industry professionals who lived the pain of inadequate software in highly regulated environments.
Built by people who've been in your shoes
Culextion was born from firsthand experience in regulated production facilities. We saw the gap between what generic ERP systems offered and what producers in compliance-driven industries actually needed — so we built the solution ourselves.
- Compliance-first architecture mapped to FDA cGMP, state regulations, FSMA, and industry-specific requirements
- Role-based access control with 21 CFR Part 11 electronic signatures, full audit trail, and section-level permissions
- Built on SOC-2 Type II certified infrastructure — no local installs, accessible anywhere, always secure
- Continuous updates driven by regulatory changes and real-world operator feedback across all industries
Let's talk about your needs
Whether you're exploring options or ready to implement, we'd love to hear from you.
Request a demo or ask for a custom quote
Send a few details about your operation — what you make, how much, and which regulatory bodies you answer to. Replies usually come within a business day.
Get a Quote
Submissions go directly to Daniel. Expect a reply within one business day.