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QT9 ERP (QT9 Software)

QT9 ERP (QT9 Software) at a glance
VendorQT9 Software
HeadquartersAurora, Illinois, USA (offices in Ireland and Australia)
OwnershipPrivately held; no outside funding or acquisition reported
DeploymentCloud (SaaS)
Target marketSmall and midsize regulated manufacturers
IndustriesMedical devices, pharmaceuticals, biotech, aerospace, food, cosmetics
PricingNot published; free trial and per-company quotes
Websiteqt9software.com

Overview

QT9 ERP is a cloud system for small and midsize manufacturers that answer to auditors. It comes from QT9 Software, an Illinois vendor whose business started with quality management rather than accounting, and that origin shapes the product. The ERP connects natively and in both directions to QT9 QMS, the company's quality management system, so production, inventory, and quality records share one data environment instead of being reconciled across two. The pitch is aimed at companies with FDA and ISO obligations that would otherwise integrate a standalone ERP with a separate quality platform.

Where QT9 ERP comes from

The company is headquartered in Aurora, Illinois, with additional offices in Killarney, Ireland, and Point Cook, Australia. It was founded in the mid-2000s and remains privately held; no outside funding or acquisition has been reported. QT9 QMS came first, an electronic quality management system for FDA- and ISO-regulated companies. QT9 ERP extended the portfolio into operations and financials, and QT9 BI adds centralized reporting across both. One vendor builds and supports all three. In a market where ERP and eQMS are usually bought from different suppliers, that is uncommon.

What it covers

On the ERP side: sales orders and quoting, purchasing, inventory management with lot and serial batch traceability, production scheduling, shop floor tracking, shipping, invoicing, and supplier management. The connected QMS side contributes document control, CAPA, nonconformance handling, audit management, employee training records, and engineering change control. Compliance tooling spans FDA 21 CFR Part 11 electronic signatures, Part 820 and the QMSR for medical devices, Part 210/211 for pharmaceuticals, ISO 13485, ISO 9001, AS9100, EU MDR, and cGMP requirements. QT9 describes its cloud environment as pre-validated, which shortens computer system validation work in life-science deployments.

Typical customers

Small and midsize medical device, pharmaceutical, and biotech manufacturers form the core, where the combined ERP-plus-eQMS footprint matches audit and traceability demands. Aerospace, food, and cosmetics companies subject to AS9100, food-safety, or MoCRA requirements also appear in the base. Buyers are primarily North American; the Irish and Australian offices support customers elsewhere.

Deployment and pricing

Browser-based cloud software, operated by the vendor. Pricing is not published. QT9 runs demonstrations and offers a free trial, and quotes are prepared per company from user counts and modules.

Editorial verdict

The single-vendor pairing of ERP and quality management is the reason to shortlist QT9, because it deletes an integration project that regulated manufacturers otherwise have to build, validate, and maintain. Small and midsize device, pharma, and biotech plants that want traceability and compliance records inside one system are the natural buyers. Manufacturers without regulatory pressure are not: the compliance machinery carries most of the value here, and general manufacturing ERPs will usually be broader or cheaper for them. Financial depth is also lighter than in dedicated mid-market accounting suites, and larger multi-site enterprises with complex costing needs typically end up evaluating heavier manufacturing ERPs instead. Use a structured selection process to test whether QT9's scope actually reaches your requirements.

What the QT9 ERP (QT9 Software) website looks like

Current view of the vendor homepage, captured by our editorial team.

Screenshot of the QT9 ERP (QT9 Software) vendor homepage

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Frequently asked questions

What is QT9 ERP, and how does it work with QT9 QMS?

QT9 ERP is a cloud-based ERP system for small and midsize manufacturers in regulated industries, developed by QT9 Software, a privately held company headquartered in Aurora, Illinois, with offices in Ireland and Australia. The same vendor also builds QT9 QMS for quality management and QT9 BI for reporting, and all three products are designed to work together. Between ERP and QMS the connection runs natively in both directions: inventory, production, and supplier records feed quality processes such as nonconformances, CAPA, and audits, while quality outcomes flow back into operations. That removes the middleware layer manufacturers usually need when pairing a generic ERP with a standalone eQMS.

Which compliance requirements does QT9 ERP address?

The platform targets FDA 21 CFR Part 11 electronic records and signatures, Part 820 and the QMSR for medical devices, and Part 210/211 for pharmaceutical manufacturing. ISO 13485, ISO 9001, AS9100, EU MDR, and cGMP-oriented workflows are supported as well. QT9 describes its cloud as pre-validated, which reduces the validation effort life-science companies must perform before go-live.

Our shop is not FDA-regulated. Is QT9 ERP still worth a look, and what does it cost?

Nothing stops a non-regulated manufacturer from running make-to-stock or make-to-order production in QT9. The catch is that much of the value sits in compliance features such as electronic signatures, audit trails, and training records that an unregulated shop may never use, and general manufacturing ERPs are often broader or cheaper for that profile. On price, QT9 Software publishes no price lists for the ERP product. Quotes are prepared individually based on user counts, modules, and whether QMS and BI are included, and prospects can request a demonstration and a free trial before entering pricing discussions.