QT9 QMS review

About the price: No public price (Oct 2026). Quoted by concurrent licences, deployment and sites, plus one-time implementation and training fees whose amounts aren't published.

What is QT9 QMS?

QT9 QMS is a quality management system from QT9 Software, Inc. in Aurora, Illinois. The company says it has served regulated manufacturers since 2005 and has more than 1,200 customers.¹ It sells to many industries, from aerospace and automotive to food, cosmetics, pharma and medical devices.² Device makers are one market among several.

QT9 also sells QT9 ERP for manufacturing, inventory and purchasing.² For device makers this matters, because device history records, device master records and UDI labels come from the ERP side, not from the QMS alone.³⁴ This review scores QT9 QMS on its own, the product you’d buy for your QMS.

QT9 has no public manual. Its help center is an AI assistant for logged-in customers.⁵ The best public evidence is QT9’s recorded webinars, which come with chapter lists and full transcripts.⁶⁷

Who QT9 QMS is for

It fits makers of physical products that:

• need nonconformance, supplier, audit, calibration and CAPA control in one system;
• run several sites or shifts, where concurrent licences help;²
• want the vendor to validate the system for them.⁸

Most G2 reviewers work at companies with 11 to 200 employees (81 of 128 reviews). Where the reviewer’s industry is shown, medical devices is the most common, followed by manufacturing and aviation.⁹

Look elsewhere if you:

• Build software as a medical device. We found no IEC 62304 features and no Jira or Git integration.¹⁰
• Need linked design controls and risk files. Design controls are described as templates, phases and a design history file built from linked records, on a marketing page only.¹⁰ One G2 reviewer calls the design control features limited, and another wants more depth for ISO 13485 and EU MDR.⁹
• Want SOP templates to get certified. We found no procedure templates. You bring your own QMS documents.

QT9 QMS pricing

QT9 doesn’t publish prices. Its pricing page asks “Why doesn’t QT9 publish pricing?” and answers that every quote is customized.² Archived copies of QT9’s sites from 2014 to 2025 show plan contents and quote forms, but no amounts.¹¹¹²

What the pricing page does say (checked 5 October 2026):²

• Annual fees: concurrent licences, for cloud or on-premise deployment.
• One-time fees: implementation services and training services. The amounts aren’t published.
• Included: all modules, customer, supplier and employee portals, a sandbox, IQ/OQ/PQ validation, Part 11 e-signatures, unlimited support and ongoing training, and help to implement further modules “at no additional charge”.

Concurrent licences mean you pay for how many people are logged in at once, not for every named user.² Capterra also lists the price as a custom quote.¹³ Several G2 reviewers call it affordable or good value. One reviewer in December 2025 wrote that prices have “risen considerably in the past few years”.⁹

Features

We checked features against QT9’s product pages and the transcripts of 13 recorded product webinars.⁶⁷¹⁴

Document control and training

The document control walkthrough covers document requests raised from change control, links to engineering change notices, training records and a collaboration workflow.¹⁵ Version 17 added parallel collaboration, so collaborators can work on a document at the same time instead of one after another.¹⁴ Training profiles, tests and training matrices are shown, and new document revisions create training records.¹⁶ Employees see assigned training and tests in an employee portal.¹⁷

Change control, CAPA and quality events

QT9 separates change control, deviations, and engineering change requests and notices, each with its own workflow.¹⁸ The CAPA walkthrough shows sources such as audits, nonconformances and complaints, 5-Why root cause analysis, tasks and a verification of effectiveness.⁶ Quality events can be escalated to a CAPA, a nonconformance, a deviation or a risk assessment.¹⁹ Complaints are handled in a customer feedback module linked to CAPA.²⁰⁴

We found no FDA MDR or EU vigilance reporting feature.

Supplier and audit management

This is where the public evidence is strongest. Walkthroughs show supplier records and certifications, scored supplier evaluations, surveys, approved supplier lists and supplier audits with checklists.⁷²¹ Suppliers answer corrective actions through a Supplier Portal.¹⁷ The audit module covers audit types, checklists, findings that create corrective actions, and auditor competence.²²

Design controls and risk

The design controls module is described only on a marketing page: templates for design processes, custom phases, links to change, FMEA and risk records, and design history files kept as technical files.¹⁰ Risk assessments and FMEA calculate risk scores and priority numbers.²³ We found no documented link from requirement to risk to verification, and no generated trace matrix or risk file.

Production records and UDI

QT9 creates device history records and device master records “using QT9 QMS and QT9 ERP software”, and UDI labels come from QT9 ERP.³⁴

What users say

• Capterra: 4.8/5 from 125 reviews, with 4.7/5 for ease of use and 4.8/5 for customer service (checked in a browser, 5 October 2026).¹³
• G2: we read 128 review texts through G2’s public feed, so G2 has at least that many.⁹ G2 blocks our browser, so its headline scores weren’t readable.

G2 likely has a few more reviews, but because we couldn’t read its ratings in a browser, we score on Capterra. We’ll check G2 again at the next review.

All 125 Capterra reviews were read in October 2026: 40 of them were posted on just seven days, in September 2019, October 2024, September 2025 and June 2026. Some reviewers posted on G2 and Capterra under the same name on the same day or a day apart. Capterra labels 22% of the reviews as invited by the vendor or by Capterra with a small incentive.¹³⁹ Because invited and burst reviews tend to skew positive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

Recurring themes on G2:⁹

• Easy to use. 38 of the 128 reviewers say so. About ten describe a dated interface or a steep start.
• Support. 32 reviewers praise it; one reports waiting until the next day for answers.
• Limited customization. At least eight reviewers report modules, reports or workflows that can’t be adapted far enough.
• Updates. On-premise customers report getting updates later than cloud customers.

We found no Reddit or other community posts from users.

Security, hosting and validation

QT9 Software holds an ISO/IEC 27001:2022 certificate from NSF-ISR, valid until March 2029.²⁴ We found no SOC 2 report for QT9 itself; its DPA says the data centres it uses are SOC 2 compliant.²⁵

Customers can choose US or EU hosting, and QT9 doesn’t mention an extra fee for it.²⁶ In June 2025 QT9 announced EU servers in a data centre in Amsterdam, with completion expected later that year and disaster recovery in London.²⁷ On-premise installation is also offered.²

The public DPA dates from March 2024. It includes EU standard contractual clauses and a sub-processor list with a hosting provider in the US and EMEA.²⁵ Validation is vendor-executed IQ/OQ/PQ, included at no extra charge.⁸ Single sign-on works for the main application and, since version 17, for the portals.¹⁴

Buying and contract terms

• Trial: you request a 7-day free trial through a form, without a credit card. A sales rep walks you through it before and after.²⁸²⁹
• Contract: the initial term is set in the order form and then renews for 12 months at a time. You may cancel at any time on 30 days’ notice, but fees are paid in advance and aren’t refunded.³⁰
• Price increases: the fee is fixed for the initial term. After that, it “may increase annually” at renewal, with 45 days’ notice and no cap.³⁰
• Leaving: the terms promise that all customer data is exported and returned within 30 days of termination, unless you’re in breach. They don’t say in which format.³⁰ Lists export to Excel and reports to PDF.¹⁶⁷ An optional add-on sends you a full daily backup.³¹
• API: QT9 says it has an open API and doesn’t charge for access. We found no public API documentation.⁴²⁶
• Go-live: QT9 says customers go live in 30 days or less.²⁹
• If the vendor is sold: the contract stays in force after a change of ownership, and QT9 may transfer it. There’s no clause for insolvency or for the service being shut down.³⁰

Company and ownership

QT9 Software, Inc. is an Illinois corporation, registered under number 64324616 and active, with annual reports filed each year from 2022 to 2026.³² The vendor says it has served manufacturers since 2005, and its founder is CEO.¹ We found no outside investors, acquisitions or change of control.

QT9 has local companies in Ireland (QT9 Software Limited, number 755136, incorporated in January 2024) and Australia (QT9 Software Solutions Pty Ltd).³³³⁴ European customers are billed in euros.³⁰ We found no published accounts.

Verdict

QT9 QMS scores 6.4. Manufacturers of physical devices that need supplier, nonconformance, audit and CAPA control across sites should shortlist it, especially if concurrent licences and EU hosting matter. Software teams, and anyone who needs linked design controls and risk files or a published price, should look elsewhere.

Visit the QT9 QMS website (made by QT9 Software, Inc.)