QT9 Software
QT9 Software provides integrated QMS and ERP software with more than 25 modules for regulated manufacturers, serving 1,200+ customers across life sciences, medical devices, pharmaceuticals, aerospace, and cannabis with pre-validated FDA 21 CFR Part 11 compliance.
- Company typePrivate
- Founded2005
- HeadquartersAurora, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What QT9 Software does
QT9 Software, founded in 2005 and headquartered in Aurora, Illinois, develops and sells integrated Quality Management System (QMS) and Enterprise Resource Planning (ERP) software for regulated manufacturers. The platform consists of three core products: QT9 QMS (25+ modules covering document control, CAPA, audits, deviations, risk management, training, inspections, and customer feedback), QT9 ERP (17+ modules covering MRP, inventory, purchasing, production tracking, bill of materials, and electronic batch/device history records), and QT9 BI for centralized reporting. The company's central technical proposition is native QMS-ERP integration that automatically generates compliance artifacts (nonconformances, CAPAs, inspection records, EBRs, DHRs) from operational transactions, eliminating duplicate data entry. The platform is pre-validated for FDA 21 CFR Part 11, EU MDR, ISO 13485, AS9100, and GxP, and is offered in cloud and on-premise deployments.
QT9 serves approximately 1,200 customers globally across life sciences, medical devices, pharmaceuticals, aerospace and defense, cannabis, and general regulated manufacturing, with named enterprise logos including Mitsubishi Electric, Shiseido, Zoll Medical, Anduril, Foxconn, and Meridian Biosciences. The company monetizes through quote-based annual subscriptions (cloud) plus perpetual or term licenses (on-premise), annual support and maintenance, and add-on professional services. Go-to-market combines a product-led free trial and self-service motion with an enterprise field sales team active at trade shows such as The ASSEMBLY Show, Automate 2026, and MD&M West, supported by a partner/reseller network and integrations with Avalara, ShipStation, Paya, HubSpot, SharePoint, Notion, Box, QuickBooks, Xero, and Sage.
QT9 has been bootstrapped since founding, holds ISO 9001:2015 and ISO 27001:2022 certifications, and operates regional offices in Ireland and Australia alongside its North America headquarters. Recent strategic activity centers on the May 2026 release of QT9 ERP 2026, which added Rework Management, Potency Tracking, Contract Services modules, upgraded forecasting, Avalara and ShipStation integrations, and an AI-driven Help Center. The company has won multiple 2025 G2 awards including High Performer Mid-Market and Momentum Leader in the QMS category.
QT9 Software firmographics
Firmographics- Name
- QT9 Software
- Legal name
- QT9 Software, Inc.
- Website
- https://qt9software.com
- Company type
- Private
- Founded year
- 2005
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- QT9 Software provides integrated QMS and ERP software with more than 25 modules for regulated manufacturers, serving 1,200+ customers across life sciences, medical devices, pharmaceuticals, aerospace, and cannabis with pre-validated FDA 21 CFR Part 11 compliance.
- Ownership category
- akta.pro rank
QT9 Software industry classification
Industry- Product category
- Quality Management and ERP Software
- NAICS
- Custom Computer Programming Services (541511), Computer Systems Design and Related Services (54151), Computer Systems Design Services (541512)
- SIC
- Services-Computer Programming, Data Processing, Etc. (7370), Services-Computer Integrated Systems Design (7373)
- akta.pro primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
- akta.pro secondary industry
- GMP Manufacturing Support Services (QA/QMS, validation, documentation) (HLAAAKAH)
Keywords
Where QT9 Software is headquartered
LocationHeadquarters
- HQ city
- Aurora
- HQ country
- United States
- HQ region
- North America
Offices4 records
Markets served
QT9 Software business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Infrastructure, Operations
Revenue model
- Software Subscription (Cloud): Cloud-based subscription access to QT9 QMS, ERP, and BI platforms. Customers pay annual subscription fees for concurrent user access via web browser.
- On-Premise Software License: Perpetual or term-based software licenses for customers who prefer to host QT9 software on their own Windows servers or customer-hosted web servers.
- Support and Maintenance: Annual support and maintenance fees including software updates, telephone and email technical support, and access to help resources.
- Professional Services: Implementation and training services available as add-on offerings to support customer deployment.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Quote-based enterprise pricing with all-inclusive model |
Go-to-market motion2 records
Distribution channels5 records
Marketing channels8 records
QT9 Software product offering
Product offeringCore offering
QT9 Software provides an integrated Quality Management System (QMS) and Enterprise Resource Planning (ERP) software platform for regulated manufacturing industries. The platform combines QT9 QMS (25+ modules for document control, CAPA, audits, deviations, risk, training, inspections), QT9 ERP (17+ modules for MRP, inventory, purchasing, production tracking, EBR, eDHR), and QT9 BI (business intelligence reporting), with native QMS-ERP integration and pre-validation for FDA 21 CFR Part 11 and ISO compliance.
Product overview
QT9 Software provides an integrated platform of quality and operations software for regulated manufacturing industries. The portfolio consists of three core products: QT9 QMS (Quality Management Software with 25+ built-in modules including document control, CAPA, audit management, deviations, risk management, training, and inspections), QT9 ERP (Unified Enterprise Resource Planning with 17+ modules covering manufacturing, MRP, inventory, purchasing, quality control, and production tracking), and QT9 BI (Business Intelligence with real-time dashboards and reporting). The QT9 Platform connects QMS and ERP natively for unified quality and operations management. QT9 MRP offers operational capabilities with integration to external accounting platforms. The platform is available in both cloud and on-premise deployments with pre-validation for FDA 21 CFR Part 11 compliance.
Differentiator
Problem solved
Functional benefit
Products and services
- QT9 QMS All-in-one Quality Management Software with 25+ built-in modules including document control, CAPA, audit management, deviation tracking, risk management, customer feedback, employee training, and inspections, designed for regulated manufacturers.
- QT9 ERP
Quantifiable outcome
- Complaint volumes drop by up to 40% for firms that invest in structured quality management
- +4 more outcomes
Companies that use QT9 Software
Customer profileNamed customers13 records
Segments6 records
Ideal customer profiles3 records
QT9 Software technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration8 records
Feature10 records
QT9 Software partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- QuickBooks, Xero, SagecoreQT9 MRP integrates with these accounting platforms for customers who prefer to maintain legacy accounting software while using QT9 for operational capabilities.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
QT9 Software competitors and assessment
Company assessmentDirect peers
- MasterControl: MasterControl is a direct competitor providing QMS and quality/regulatory software to regulated manufacturers in life sciences, medical devices, and other GxP industries. Highly comparable on customer base, vertical focus, and the combined QMS+manufacturing execution pitch.
- ETQ Reliance (Hexagon): ETQ Reliance, now part of Hexagon, is the closest named competitor QT9 benchmarks itself against on G2 ratings and implementation speed. Both serve regulated manufacturers with QMS software for document control, CAPA, and compliance, making it a head-to-head direct peer.
- Greenlight Guru: Greenlight Guru provides QMS and quality management software purpose-built for the medical device industry, overlapping directly with QT9's life-sciences and medical-device QMS offering. Both target mid-market regulated manufacturers with cloud-based eQMS platforms.
- Qualio: Qualio is a cloud-native eQMS focused on life sciences and medical-device manufacturers, directly competing with QT9 QMS in the mid-market segment. Both target fast-growing regulated manufacturers seeking rapid, validated QMS implementation.
- ComplianceQuest: ComplianceQuest delivers a native Salesforce-based QMS + ERP suite for regulated manufacturers, closely mirroring QT9's integrated QMS-ERP positioning. Both pitch a unified quality-and-operations platform to mid-market regulated manufacturers.
- AssurX: AssurX provides regulated QMS software for life sciences, medical devices, and manufacturing, overlapping with QT9's primary verticals and product modules (CAPA, document control, audit). Comparable mid-market regulated-manufacturing customer profile.
Broad incumbents
- Veeva Systems: Veeva is a broad incumbent in life-sciences cloud software with Vault QMS, Vault QualityDocs, and regulated-content offerings. It competes with QT9 in pharma/medical-device QMS but is much larger and offers a far broader suite beyond quality management.
- Sparta Systems (a Honeywell company): Sparta Systems' TrackWise QMS, now part of Honeywell, is an established enterprise QMS serving regulated life sciences and discrete manufacturers. It competes with QT9 in pharma/medical-device QMS but skews toward larger enterprise customers with longer implementations.
- NetSuite (Oracle): NetSuite is a broad cloud ERP incumbent that competing mid-market manufacturers may use instead of QT9 ERP for operations. While not a pure QMS peer, it is frequently evaluated head-to-head against QT9 ERP for regulated mid-market manufacturing deployments.
Emerging players
- Dot Compliance: Dot Compliance offers AI-enabled, ready-to-use QMS solutions for life sciences built on the Salesforce platform. It competes with QT9 in pharma/medical-device eQMS but with a more emerging-player profile and narrower ERP footprint.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
QT9 Software social profiles
Digital presenceQT9 Software compliance and trust
Trust signalCompliance11 records
QT9 Software financial estimates
Financial estimateRevenue estimate
Valuation estimate
QT9 Software leadership team
Management profileNumber of profiles
Profiles2 records
QT9 Software funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
QT9 Software M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about QT9 Software
What does QT9 Software do?
QT9 Software provides an integrated Quality Management System (QMS) and Enterprise Resource Planning (ERP) software platform for regulated manufacturing industries. The platform combines QT9 QMS (25+ modules for document control, CAPA, audits, deviations, risk, training, inspections), QT9 ERP (17+ modules for MRP, inventory, purchasing, production tracking, EBR, eDHR), and QT9 BI (business intelligence reporting), with native QMS-ERP integration and pre-validation for FDA 21 CFR Part 11 and ISO compliance.
Is QT9 Software a public or private company?
QT9 Software is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was QT9 Software founded?
QT9 Software was founded in 2005. It employs 11 to 50 people.
Where is QT9 Software based?
QT9 Software is headquartered in Aurora, United States, in the North America region.
How does QT9 Software make money?
Four revenue lines are on record. Software Subscription (Cloud) is the primary driver. The others are on-Premise Software License, support and Maintenance and professional Services.
Who are QT9 Software's main competitors?
Direct peers on record are MasterControl, ETQ Reliance (Hexagon), Greenlight Guru, Qualio, ComplianceQuest and AssurX. Broad incumbents are Veeva Systems, Sparta Systems (a Honeywell company) and NetSuite (Oracle). Dot Compliance is listed as an emerging player.
Does QT9 Software have an API?
No public API is recorded for QT9 Software.
What industry is QT9 Software in?
QT9 Software's product category is Quality Management and ERP Software. Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation, with a secondary code of HLAAAKAH, GMP Manufacturing Support Services (QA/QMS, validation, documentation). Its NAICS code is 541511 and its SIC code is 7370.