QT9 QMS
QT9 QMS works great for life sciences like medical devices/pharmaceuticals. The included 25 modules can be a lot for new users, but the robust tools offered by the QMS help businesses meet FDA and ISO compliance, along with industry-specific standards like AS9100, IATF 16949, and SQF Food Safety. There’s also unlimited training to help users master each module.
While the user interface could be a bit more sleek, the incredibly fast implementation makes up for it by getting you ready to go faster than other QMS products. And the ability to generate reports helps when it’s time to show compliance to internal or external parties.
- Flexible deployment options with access on all devices.
- Has 25+ pre-installed modules for advanced functionality.
- Full validation included for life sciences companies.
- Concurrent licensing enables organizations to use less licenses.
- Implementation and training are required plus an additional fee.
- No pre-built QuickBooks integration.
- Developer QT9 QMS
- Client OS Windows, macOS, Linux, iOS, Android, Web
- Deployment Cloud or On-Premises
What is QT9 QMS?
QT9 QMS is a quality management system with over 28 modules included in every subscription, available in the cloud or an on-premise install. It’s ideal for regulated manufacturers moving off spreadsheets and paper records for the first time.
The platform integrates document control, CAPA, audits, training, and inspections into a single system rather than treating them as separate tools. Quality events, audit findings, and customer complaints can each launch a CAPA with the source record’s data already filled in. QT9 ships the software pre-validated with IQ, OQ, and PQ protocols executed, which removes the validation project that many buyers would otherwise budget months for.
Target Market
QT9 QMS fits small and mid-sized regulated manufacturers, including multi-site organizations that need consistent workflows across locations. Very large global manufacturers may find it thinner than SAP or QAD on multi-entity depth.
Industries served:
- Life Sciences
- Pharmaceutical
- Biomedical
- Medical Device
- Food and Beverage
- Plastics
- Aerospace and Defense
- Cannabis
- Chemicals
- Cosmetics
- Automotive
- Electronics
- Metals and Mining
Data can be hosted in the United States or the European Union.
Our Ratings
| Usability - 8.5 | The interface could be more sleek; To-Do List lets users instantly see what tasks are upcoming or need attention from the home page; intuitive navigation. |
| Support - 9.1 | Includes unlimited support and user training from implementation and beyond; a knowledge-base and webinars also help users; free upgrades to new versions are included. |
| Features - 9.0 | Straightforward processes; automated notifications keep users on task; software is accessible from any web browser and device. |
| Security - 9.5 | Limited concurrent user licenses ensure only so many users can access software at a time, global administrators can remove active users; inactive users can be automatically removed to free up seats. |
| Value - 8.3 | Pricing is quote-only and scales with concurrent users, deployment method, and number of sites; all 28+ modules are included at no extra license cost; implementation and training are separate required fees; a free trial is available. |
| Performance - 8.6 | Functionality was fast and responsive; generating large reports can take a few seconds to complete; no other slowness or performance issues. |
| Scalability - 8.7 | Plans are available with concurrent and static annual licenses that enable unlimited users; new users can be added during annual renewal or earlier (prorated). |
Features
Electronic Signature Approvals
QT9 QMS supports electronic signature approvals under FDA 21 CFR Part 11, creating a traceable approval record for audits and internal review. Signatures tie into the document control module, so permissions govern who can read, view, or edit each document.
Built-In Modules
Every module ships with the subscription, so there’s no extra license cost or separate implementation fee to turn one on later. Training on modules you adopt after go-live is included. Multi-site organizations can connect facilities across states or countries on a shared platform.
Version 17 Updates
- Audit Prep module: Automatically compiles overdue or missing records ahead of an audit, including open corrective actions, nonconforming product, deviations, missing training, and overdue equipment maintenance.
- Parallel document collaboration: Reviewers can work on a document at the same time instead of only in sequence.
- Incident reports in the Quality Events module.
- Training records generated directly from quality events or corrective actions.
- SSO for the Document Portal and Employee Portal.
- Site-specific date formats for global teams.
Add-Ons
Beyond the QMS subscription, QT9 sells a business intelligence tool, an unlimited-user document portal, a SQL reporting and backup tool, and QT9 Data Sync for connecting an outside ERP.
Pricing Plans
QT9 QMS Pricing
QT9 no longer publishes pricing. Quotes are custom and issued after a consultation.
For a rough anchor: quotes we reviewed in early 2025 came in around $2,200 per concurrent user per year for the base QMS package. Treat that as a starting point, not a current rate. QT9 has moved to fully custom pricing, and the figure will vary based on your deployment method, site count, and implementation scope.
| Plan (2025) | Pricing | Features |
| Base Package | $2,200 per concurrent user per year | The main QMS package includes 28 modules which cover:
|
Licensing is annual and based on concurrent users, not named users. You pay for the maximum number of people logged in at once, so a 40-person quality team that never has more than 10 people in the system licenses 10 seats.
Employee training and supplier access sit outside the concurrent count, so you aren’t buying licenses to onboard staff or share documents with vendors.
Factors that move the quote:
- Number of concurrent users
- Cloud subscription vs. on-premise deployment
- Number of facilities or business locations
- Implementation and training scope
All 28+ modules are included at no extra license cost, so there are no per-module upcharges. Implementation and training are separate one-time fees, and that fee unlocks unlimited ongoing training for new and existing users. Free software upgrades are included, and QT9 ships releases roughly every 12 to 18 months.
A free trial is available.
Alternatives
Summary
QT9 QMS is a good fit for regulated manufacturers that have outgrown spreadsheets and want compliance coverage without an enterprise implementation. It won’t match SAP or QAD on multi-entity depth, and its collaboration tools trail newer platforms, but it’s a modernized system that keeps you audit-ready and prices predictably.
The all-modules-included license is the main reason it lands on shortlists. You can turn on supplier management or design controls two years after go-live without a new contract or a new implementation fee. If you’re comparing options, see our QT9 QMS alternatives roundup.
Video Overview
Frequently Asked Questions
How many modules does QT9 QMS offer?
QT9 groups its over 28 modules into seven categories rather than selling them a la carte:
- Core: Document control, audit management, training management, risk management.
- Main: Corrective actions, quality events, deviations, inspections.
- Management: Procedure changes, approvals, and high-level oversight.
- Maintenance: Calibration tracking and preventive maintenance scheduling, which replaces standalone calibration tools like GageTrak for some buyers.
- Product: Engineering change control, parts nonconformance, FMEA, design controls.
- Customer: Complaint tracking, customer surveys, customer web portal.
- Supplier: Vendor risk and performance evaluations, supplier web portal.
The supplier and customer portals let you share traceability documents outside the system without buying additional licenses, which matters for food manufacturers working against FDA traceability request windows.
What compliance codes does QT9 support?
Does QT9 QMS work as an ERP?
Can it integrate with my ERP?
User Reviews of QT9 QMS
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QT9 QMS Review
Overall, it has been a good experience and wonderful quality management system. Cost has been only downside as increases year to year can be as little as 0% to 23% with it averaging out to 13% year to year.
Pros
Document control, external documents, audit scheduling and ISO functions.
Cons
Pricing has increased 60% since initial implementation in 2021.
QT9 QMS Review
This is the best QMS software for the money. It’s intuitive, easy to implement and reliable.
