QT9 Software

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.

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

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

• Quality management software
• Enterprise resource planning
• Regulated manufacturing software
• Compliance management system
• Electronic batch records

Headquarters

HQ city

Aurora

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Infrastructure, Operations

Revenue model

1. 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.
2. 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.
3. Support and Maintenance: Annual support and maintenance fees including software updates, telephone and email technical support, and access to help resources.
4. Professional Services: Implementation and training services available as add-on offerings to support customer deployment.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels8 records

Core 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

Named customers13 records

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration8 records

Feature10 records

Partnerships

One partnership is on record.

• QuickBooks, Xero, SagecoreTechnology or IntegrationQT9 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

Direct 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

• Xx.com/qt9software
• Facebookfacebook.com/QT9software
• LinkedInlinkedin.com/company/qt9-software

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about QT9 Software