QT9 QMS
All-in-one QMS and ERP software that simplifies compliance for regulated manufacturers
By QT9 Software · HQ Aurora, US · 4.8/5 verified-buyer score
Positioning guardrails
Best for
- Regulated manufacturers in medical devices, aerospace, automotive, pharma and food & beverage that must satisfy ISO 9001, ISO 13485, AS9100 or FDA 21 CFR Part 11.
- Quality teams replacing spreadsheets, email and disconnected point tools with one electronic quality management system.
- Companies that want quality management and ERP (inventory, purchasing, manufacturing) connected in a single system with shared data.
- Organizations needing cloud or on-premise deployment plus multi-site, supplier and customer self-service portals.
- Buyers who value a pre-validated (IQ/OQ/PQ) environment to cut their own computer-system validation effort.
Ideal size: 20–1,000+ employees people · Regulated manufacturer or life-sciences firm with an owned quality/compliance function
Not for
- Patient-facing healthcare providers such as hospitals and clinics; QT9 targets regulated manufacturing, not clinical care workflows.
- Teams that need published list pricing and instant self-serve online signup; QT9 quotes every deal.
- Very small shops with no regulatory, customer or audit-driven quality obligations.
- Companies wanting a lightweight, single-purpose document repository rather than a full QMS/ERP suite.
- Service businesses outside manufacturing, such as retail, hospitality, education and professional services.
Value metrics scorecard
Time-to-Value
Rapid cloud deployment (weeks)
~30 days to first production value
Total Cost of Ownership
$0/yr
Starts at $0 · Annual licensing on concurrent-user counts; cloud subscription, on-premise or hybrid; custom quote based on users, product, sites and implementation scope
Implementation Friction
2/5
Engineering + admin effort required
Buyer Score
out of 5 · verified buyers
Full cost breakdown
Mandatory implementation fee
None
Seat tiers
Concurrent licenses — a set number of users share a pool of access rights rather than named seats; no published seat minimum
Add-on costs
- Implementation services are quoted separately from the license
- Training services are quoted separately (the unlimited-training inclusion excludes ERP implementation)
Company & support
Who is behind QT9 QMS, and how your team gets help once it is live.
Company
- Founded
- 2005 · 21 yrs in business
- Headquarters
- Aurora, US
How you get support
- PhoneAll plans
- EmailAll plans
- Live chatNot listed
- Support portal / ticketsNot listed
- Community forumNot listed
- Help centre / docsAll plans
- Dedicated account managerNot listed
- In person / on-siteNot listed
- Hours
- Not recorded
- Response time
- Not stated
Every quote includes unlimited training and support, free upgrades, a help center and QT9 University; unlimited training excludes ERP implementation. Site states help is a call or email away.
“Not listed” means the vendor’s public pages don’t mention that channel, not that it is unavailable. Ask about it during evaluation.
Market position
Where QT9 QMS sits relative to every other solution in the database. Toggle axes to compare on cost, speed, friction, or buyer score.
Quadrant view
Implementation friction × Verified buyer score
Stack fit signal
Compatibility with standard B2B ecosystems.
No supported MCP path today, so it cannot be driven from an AI client.
AI & MCP readiness
What QT9 QMS ships in AI, and what it asks of your ecosystem.
Industry verdicts
How QT9 QMS speaks to each vertical it serves — same data, sector lens.
ManufacturingShip on time, quote faster, cut scrap.
Best for in Manufacturing
- Medical device, aerospace, automotive, plastics, metals and food & beverage manufacturers with ISO 9001, ISO 13485 or AS9100 obligations.
- Multi-site plants that need one quality system with timeline traceability for audits and recalls.
- Teams replacing spreadsheet and email workflows for CAPA, nonconformances, audits, deviations and supplier quality.
- Manufacturers that want QMS and ERP (inventory, purchasing, manufacturing) connected in one system.
- Buyers who want a pre-validated (IQ/OQ/PQ) environment to shorten their own validation work.
Not for
- Light manufacturers with no regulatory, customer or audit-driven quality requirements.
- Companies wanting a low-cost, self-serve purchase completed online without a sales cycle.
- Teams that only need basic document storage and no CAPA, audit, training or supplier workflows.
QT9 positions its QMS and ERP as built for regulated manufacturing, listing manufacturing, medical devices, aerospace, automotive, chemicals, plastics, metals & mining, electronics, cosmetics and food & beverages as target segments. All modules are included at no extra license cost and the platform is pre-validated for ISO 9001, ISO 13485, ISO 14001, ISO 17025, AS9100 and MoCRA, with IQ/OQ/PQ execution offered. Cloud or on-premise deployment and multi-site support fit firms with several plants. Pricing is quote-based, so buyers should expect a demo and scoping cycle rather than instant purchase.
HealthcareMore patients, less paperwork.
Best for in Healthcare
- Medical device and pharmaceutical manufacturers working to FDA 21 CFR Part 11/820, EU MDR, EU cGMP or GxP.
- Life-sciences quality teams managing design history files, device history records and electronic batch records.
- Organizations needing electronic signature approvals and role-based access control over regulated records.
- Teams preparing for inspections where complete, time-stamped audit trails matter.
Not for
- Hospitals, clinics and care providers managing patient records rather than product quality.
- Healthcare organizations seeking clinical EHR, scheduling or billing functionality.
- Research labs that need LIMS or ELN capability rather than QMS/ERP.
QT9's life-sciences fit is on the manufacturer side: medical devices and pharmaceuticals appear in the vendor's target industry list, and the site claims support for FDA 21 CFR Part 11, 210/211, 820/QMSR, EU cGMP, EU MDR and GxP, plus supporting GDPR and EU MDR compliance. Electronic batch records, device history records and validation protocols (IQ/OQ/PQ) are promoted as ready to use. No HIPAA, SOC 2 or ISO 27001 certification is claimed on the vendor's compliance page, so provider-side buyers with those requirements should validate directly.
Compliance attestations
* IAPP AIGP certifies individuals, not products. It means named staff hold the credential — not that the platform does.
Bottom line
QT9 Software sells an integrated QMS and ERP suite for regulated manufacturers, serving 1,200+ customers. Modules cover document control, CAPA, audits, nonconformances, deviations, risk, supplier quality, training and electronic batch/device history records, plus ERP for inventory, purchasing and manufacturing. It deploys in cloud or on-premise and ships pre-validated for ISO 9001, ISO 13485, AS9100 and FDA 21 CFR Part 11, with IQ/OQ/PQ execution. Licensing is annual, per concurrent user, by custom quote; unlimited support and training are included.
Frequently asked questions
How much does QT9 QMS cost?
QT9 does not publish list prices. Pricing is quoted per organization and scales with the number of concurrent users, the product selected (QMS or ERP), deployment (cloud, on-premise or hybrid), implementation requirements and the number of facilities. Every quote includes all modules, pre-validation (IQ/OQ/PQ), unlimited training and support, and free upgrades, while implementation and training services are quoted separately. Expect a demo and quote process rather than self-serve checkout.
How long does implementation take?
QT9 emphasizes rapid cloud deployment and a fully pre-validated environment, and customers quoted on the site describe implementation as easy and quick. Exact timing depends on modules selected, number of sites, data migration and how much of your own validation you choose to perform; on-premise deployments add IT set-up time. Because all modules are included with no separate license cost and the software is pre-validated, most of the effort is configuration and process alignment rather than software build.
Which standards and regulations does QT9 support?
The vendor lists ISO 13485, ISO 9001, ISO 14001, ISO 17025, AS9100 and MoCRA on the quality side, and FDA 21 CFR Part 11, FDA 21 CFR Part 210/211, FDA 21 CFR Part 820 & QMSR, EU cGMP, EU MDR and GxP on the regulatory side. The site also states that validation protocols including Installation Qualification, Operational Qualification and Performance Qualification are executed as part of the pre-validated solution.
Is QT9 available in the cloud or on-premise?
Both. QT9 offers cloud subscription and on-premise deployment, and describes the core functionality as the same. With on-premise, the software runs on your own servers managed by your IT team, giving control over infrastructure, data residency and security configuration; with cloud, QT9 hosts and maintains the environment in its data centers, providing automatic updates, access from anywhere and reduced internal IT burden.
How does concurrent-user licensing work?
Concurrent licenses let multiple users share a pool of access rights, so only a set number of users can be logged in at the same time. QT9 positions this as a cost-optimization model: you pay for the maximum number of simultaneously active users you expect rather than a named seat for every employee, which suits shift-based manufacturing and quality teams.
Do we have to validate the software ourselves?
QT9 markets its solutions as pre-validated, with every module and feature tested and documented, and states that complete execution of IQ, OQ and PQ protocols is included. The vendor argues this eliminates lengthy internal validation work, reduces downtime waiting for approval to use the system, and lowers the risk of failed audits from flawed validation protocols. Customers remain responsible for their own process validation and records.