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QT9 QMS

qt9software.com

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Spec score 8.2 #3 of 22 in Environmental, Quality and Safety Management Software

What it is

QT9 QMS is quality management software for regulated manufacturers, built to automate compliance and quality processes. It includes more than 28 modules, such as document control, audit and risk management, CAPA, inspections and supplier evaluations. Configurable workflows, approval controls, email alerts, reporting, timeline traceability and Excel exports support quality operations. Deployment can be cloud, on-premise or hybrid, with hosting in the U.S. and Europe. QT9 says the browser-accessed system needs no installation and works on PC, Mac and Linux. It describes the software as pre-validated with IQ/OQ/PQ and compliant with FDA 21 CFR Part 11, and lists support for ISO 13485, ISO 9001, EU MDR and AS9100. Security features listed include end-to-end encryption, two-factor authentication and role-based access; the maker also states 99.9% cloud uptime. QT9 QMS integrates with QT9 ERP and supports API connectivity. The company says it has served regulated manufacturers since 2005. Pricing is custom based on users and deployment requirements, and a free trial is available.

Spec sheet

Purpose
QT9 QMS is quality management software designed to automate compliance and quality processes for regulated manufacturers.Read 29 Sep 2026 · qt9software.com
Intended users
The maker positions QT9 QMS for regulated manufacturers, including medical device, pharmaceutical, aerospace, automotive, food and laboratory organizations.Read 29 Sep 2026 · qt9software.com
Deployment
QT9 QMS is offered as cloud, on-premise or hybrid deployment with U.S. and European hosting options.Read 15 Oct 2026 · qt9software.com
Security
The platform page lists end-to-end encryption, two-factor authentication, role-based access and 99.9% cloud uptime, and says data is hosted in dedicated U.S. and EU data centers.Read 29 Sep 2026 · qt9software.com
Headquarters
Aurora, Illinois, United StatesRead 28 Sep 2026 · qt9software.com
Founded
2005Read 28 Sep 2026 · qt9software.com
API capability
TrustRadius lists an API feature for QT9 QMS and shows a 5.0 feature rating from one rating.Read 15 Oct 2026 · trustradius.com
Browser access
QT9 describes the product as browser-based and accessible from PCs, Macs, Chromebooks, Linux devices and mobile devices.Read 15 Oct 2026 · qt9qms.com
Browser and operating systems
The maker says QMS is accessed through a web browser, requires no installation and works on PC, Mac and Linux.Read 29 Sep 2026 · qt9software.com
Company fact on Gartner
Gartner Peer Insights lists QT9 Software as private, founded in 2005, headquartered in Aurora, United States, with 11–50 employees.Read 15 Oct 2026 · gartner.com
Company history
QT9 Software says it has served regulated manufacturers since 2005 and has more than 1,200 customers.Read 29 Sep 2026 · qt9software.com
Company profile
LinkedIn lists QT9 Software as a privately held software-development company founded in 2005 with headquarters in Aurora, Illinois and 11–50 employees.Read 15 Oct 2026 · linkedin.com
Compliance automation
Compliance functions include electronic-signature approvals, revision control, IQ/OQ/PQ validation and audit trails.Read 15 Oct 2026 · qt9software.com
Document control
Document control supports review, storage, revision control, training links, parent-child relationships and sharing with customers and suppliers.Read 15 Oct 2026 · qt9software.com
Documentation and support
QT9 advertises a 24/7 AI help center, searchable guides, tutorials, webinars, QT9 University, unlimited training and unlimited support.Read 15 Oct 2026 · qt9software.com
ERP integration
QT9 QMS has native real-time integration with QT9 ERP through a shared architecture.Read 15 Oct 2026 · qt9software.com
External integrations
QT9 Data Sync can connect with NetSuite, Microsoft Dynamics 365, Sage, Great Plains, Acumatica, E2, Infor, Epicor and local SQL databases.Read 15 Oct 2026 · qt9software.com
File attachments
The features page lists unlimited file attachments, while the QMS overview states a 150 MB per-file limit.Read 29 Sep 2026 · qt9software.com
File limit
QT9 states that storage is unlimited but individual files are limited to 150 MB.Read 15 Oct 2026 · qt9software.com
Free trial
QT9 offers a free trial with no credit card required, but the trial page does not state its duration.Read 29 Sep 2026 · qt9software.com
Implementation claim
QT9 says implementation can take as little as 30 days, depending on organization size, process complexity and available resources.Read 15 Oct 2026 · qt9software.com
Included modules
The platform includes more than 28 integrated modules.Read 15 Oct 2026 · qt9software.com
Integration
QT9 QMS integrates natively with QT9 ERP and supports API connectivity; the maker also describes a data-sync add-on compatible with systems including NetSuite, Microsoft Dynamics 365, Sage, Acumatica and Epicor.Read 29 Sep 2026 · qt9software.com
Legal entity
The on-premise license agreement identifies the contracting company as QT9 Software, Inc.Read 15 Oct 2026 · legal.qt9software.com
Licensing model
The on-premise agreement grants a perpetual, nonexclusive, nontransferable license for internal business use and states that QT9 owns the software.Read 15 Oct 2026 · legal.qt9software.com
Limit: interface and navigation
TrustRadius reviewers report that graphics and navigation could be improved and that vendor or customer interfaces are not always smooth.Read 15 Oct 2026 · trustradius.com
Limit: missing standards workflows
Capterra reviewers say some ISO 13485 best-practice workflows, such as staged CAPA approvals and task-due reminders, are missing out of the box.Read 15 Oct 2026 · capterra.com
Limit: reporting and customization
TrustRadius reviewers describe reporting as clunky and request more user-defined fields, categories and approval points.Read 15 Oct 2026 · trustradius.com
Limit: supplier document workflow
Capterra reviewers report that suppliers cannot request or automatically upload expired documents without direct interaction.Read 15 Oct 2026 · capterra.com
Modules
The product includes more than 28 quality modules, including document control, audit management, risk management, CAPA, inspections and supplier evaluations.Read 29 Sep 2026 · qt9software.com
Notable news
QT9 announced that QT9 QMS received 2026 honors from Capterra and Software Advice and reported an overall 4.8/5 rating across Gartner Digital Markets platforms.Read 15 Oct 2026 · qt9software.com
Portals
Customer, employee and supplier web portals are available, while the features page marks document portals for unlimited users as optional and directs buyers to contact QT9 for a quote.Read 29 Sep 2026 · qt9software.com
Praise: centralized quality data
TrustRadius reviewers praise centralized documents, nonconformance and supplier-quality tracking, and easier audit preparation.Read 15 Oct 2026 · trustradius.com
Praise: implementation and value
Software Advice reviewers commonly praise fast implementation, comprehensive modules, affordability and reduced administrative work.Read 15 Oct 2026 · softwareadvice.com
Praise: usability and support
G2 reviewers repeatedly praise intuitive use, quick adoption, task automation and responsive customer support.Read 15 Oct 2026 · g2.com
Product purpose
QT9 QMS is a pre-validated electronic quality-management system for regulated manufacturers.Read 15 Oct 2026 · qt9software.com
Quality assurance
Quality tools include defect, equipment, incident, inspection and supplier-quality management plus ERP integration.Read 15 Oct 2026 · qt9software.com
Rating on Capterra
4.8 out of 5 from 126 reviewsRead 15 Oct 2026 · capterra.com
Rating on G2
4.8 out of 5 from 129 reviewsRead 15 Oct 2026 · g2.com
Rating on Gartner Peer Insights
5.0 out of 5 from 1 reviewRead 15 Oct 2026 · gartner.com
Rating on GetApp
4.8 out of 5 from 126 reviewsRead 15 Oct 2026 · getapp.com
Rating on Software Advice
4.8 out of 5 from 124 reviewsRead 15 Oct 2026 · softwareadvice.com
Rating on TrustRadius
9.8 out of 10 from 14 reviewsRead 15 Oct 2026 · trustradius.com
Regulatory support
QT9 describes QMS as pre-validated with IQ/OQ/PQ and compliant with FDA 21 CFR Part 11; it lists support for standards including ISO 13485, ISO 9001, EU MDR and AS9100.Read 29 Sep 2026 · qt9software.com
Security and compliance
QT9 states that the product is FDA 21 CFR Part 11 compliant, pre-validated and supports automatic audit trails and electronic signatures.Read 15 Oct 2026 · qt9software.com
Training and support
QT9 pricing lists unlimited training and support, and the maker advertises annual software upgrades.Read 29 Sep 2026 · qt9software.com
Training management
Training features include assessments, assignments, courses, reminders, self-learning, skills tracking and tests.Read 15 Oct 2026 · qt9software.com
Validation protocols
The product includes Installation Qualification, Operational Qualification and Performance Qualification protocols.Read 15 Oct 2026 · qt9software.com
Web portals
Customer, employee and supplier web portals are provided, while the document portal is an optional feature requiring a quote.Read 15 Oct 2026 · qt9software.com
Workflows and reporting
Features include configurable workflows, approval controls, email alerts, real-time reporting, timeline traceability and Excel exports.Read 29 Sep 2026 · qt9software.com

Plans and prices

QT9 QMS Priced on request Annual licensing; concurrent licenses; cloud subscription or on-premise deployment All modules included · pre-validated IQ/OQ/PQ · FDA 21 CFR Part 11 compliant · unlimited training and support · free upgrades Read 15 Oct 2026 · qt9software.com

Every QT9 QMS plan and price →

Strong points and limits

Strong points

  • More than 28 quality modules are included.
  • Cloud, on-premise and hybrid deployment are available.
  • Supports PC, Mac and Linux through a browser.
  • Lists two-factor authentication and role-based access.
  • A free trial is available.

Limits

  • No free plan is listed.
  • Pricing is available on request.
  • Document portals for unlimited users are optional.
  • File attachments have a 150 MB per-file limit.

Who it suits

QT9 QMS is aimed at regulated manufacturers, including medical device, pharmaceutical, aerospace, automotive, food and laboratory organizations. It may suit teams that need configurable quality workflows and regulatory support.

QT9 QMS in depth

Read the full write-up

QT9 QMS is a quality-management platform aimed at regulated manufacturers that need extensive process coverage and deployment flexibility. It fits organizations managing formal compliance across multiple quality activities; the trade-off is a quote-based purchase that requires a closer commercial review.

Overview

QT9 QMS combines more than 28 modules for document control, audits, risk management, CAPA, inspections and supplier evaluations. That breadth can replace a collection of point tools and give quality teams one place to manage records and workflows. It is most compelling when several of those disciplines must operate under a common control model rather than when a company needs only a narrow document repository.

QT9 Software says it has served regulated manufacturers since 2005 and has more than 1,200 customers. The product is positioned for medical-device, pharmaceutical, aerospace, automotive, food and laboratory organizations. QT9 describes the system as pre-validated with IQ/OQ/PQ and compliant with FDA 21 CFR Part 11, with support for ISO 13485, ISO 9001, EU MDR and AS9100. Those capabilities make it a serious candidate for regulated environments, while each organization still needs to align configuration and procedures with its own obligations.

Key features

Revision history, document expiry controls, document control, approval workflows, electronic signatures and audit trails cover the mechanics of controlled quality documentation. Role-based access separates permissions, and compliance records, nonconformance tracking and corrective actions extend the system into ongoing quality operations rather than stopping at file storage.

Configurable workflows and approval controls help formalize reviews; email alerts can prompt action when work moves between stages. Timeline traceability provides a chronological view of activity, while real-time reporting and Excel exports support operational analysis and handoffs to teams that still work in spreadsheets. These tools favor organizations that need evidence of who approved what and when.

Integration is strongest for existing QT9 customers: the QMS connects natively with QT9 ERP and offers API connectivity. A data-sync add-on is described as compatible with NetSuite, Microsoft Dynamics 365, Sage, Acumatica and Epicor, which may reduce duplicate entry for organizations on those systems. Customer, employee and supplier web portals are available. Document portals for unlimited users are optional, so companies with broad external access should confirm that requirement and its added quote before committing. File attachments are described as unlimited, but individual files are limited to 150 MB.

Security provisions include end-to-end encryption, two-factor authentication, role-based access and a stated 99.9% cloud uptime. Data is hosted in dedicated U.S. and EU data centers, giving organizations a choice of regional hosting. QT9 also includes unlimited training and support in its pricing description and advertises annual software upgrades.

Pricing

QT9 QMS uses annual licensing with custom pricing based on users and deployment requirements. Concurrent licenses, cloud subscription and on-premise deployment are supported, and the plan includes all modules, implementation services and training. There is no free plan, but a free trial is available.

This structure suits manufacturers that need the full module set and want licensing tied to concurrent use or a selected hosting model. It is less convenient for small teams seeking a transparent monthly budget or a narrowly scoped starting package: there are no published entry prices to compare, and optional unlimited-user document portals can add to the quote. Buyers should also clarify how their user counts, deployment choice and portal needs affect the annual total.

Platforms

QT9 QMS runs through a web browser and requires no installation, working on PC, Mac and Linux. Deployment can be cloud, on-premise or hybrid, with hosting in the United States or Europe. API connectivity supports integration scenarios, while the browser model gives distributed quality teams a consistent access method across Windows, macOS and Linux environments.

Who it's for

Choose QT9 QMS when a regulated manufacturer needs broad quality coverage, formal approvals and traceability in one system, especially if it already uses QT9 ERP or requires cloud, on-premise and hybrid choices. Its regulatory positioning and dedicated regional hosting are relevant to organizations with documented compliance and data-residency concerns.

It is a weaker fit for a small operation that needs only basic document control, a published low-cost plan or a hard-capped free tier. Those buyers may pay for modules and implementation capacity they will not use, and the custom quote makes quick price screening difficult.

Pros and cons

Pros

Broad module coverage: More than 28 modules span documents, audits, risk, CAPA, inspections and suppliers.

Deployment choice: Cloud, on-premise and hybrid options accommodate different IT and compliance policies.

Regulatory controls: Electronic signatures, audit trails, IQ/OQ/PQ validation and support for major listed standards fit controlled environments.

Integration and support: QT9 ERP integration, API access, optional data synchronization, unlimited training and support reduce adoption barriers.

Cons

Opaque cost: Annual pricing is custom, so organizations must obtain a quote before making a meaningful comparison.

Optional document portals: Unlimited-user document portals are not part of the standard inclusion and may require extra spending.

Attachment ceiling: Unlimited attachments still have a 150 MB limit per file.

Potential overkill for narrow needs: Smaller teams seeking only basic quality documentation may not need its full module breadth.

Alternatives

Document Control Software is a useful category comparison when controlled documents, rather than a complete QMS, are the priority. Quality Management Software provides a wider shortlist for comparing full quality platforms.

GatesFlow QMS is the better starting point for individuals or small teams that want a free tier or a $20-per-month paid plan, with web and API access. DocControl suits buyers seeking transparent document-focused pricing, starting at $49 per month for two users and 1 GB of storage. Qualsys EQMS is another paid EQMS option with Android, iOS and web access.

Intelex Inspection Management is worth choosing when inspection and incident work is central and a $44-per-year Safety Essentials plan with a 25-user minimum fits. OnPolicy is more focused on policy and procedure management, with a $990-per-year plan. QualiVault favors very small deployments through a perpetual two-seat free tier and a $9.99-per-month Basic plan. TrackWise Digital offers paid QuickTrack and QMS Suite options for startups and growing businesses, with pricing supplied by quote. IQVIA SmartSolve Complaint Management is a paid complaint-management alternative sold through a sales quote.

Verdict

QT9 QMS is a strong choice for regulated manufacturers that need one broad, traceable quality system and the freedom to deploy it in the cloud, on-premise or in a hybrid model. Its main reason to choose is the combination of extensive modules, compliance controls and integration options; its main reason to look elsewhere is custom annual pricing, particularly if you need only basic document control or a low-cost, transparent plan.

Verdict

QT9 QMS combines a broad module set with several deployment options and listed regulatory support. Buyers should confirm custom pricing and whether optional document portals are needed.

Where Specifiction places it

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