QT9 QMS

QMSQMSPharma Edition Available

4.8(20 reviews)

Cloud-based quality management system (QMS) and enterprise resource planning (ERP) software for highly regulated industries including pharmaceuticals, medical devices, and life sciences. Pre-validated for FDA 21 CFR Part 11 compliance with over 25 integrated modules including electronic batch records, CAPA, document control, and audit management.

QT9 QMS is an all-in-one quality management and enterprise resource planning platform for highly regulated industries, including pharmaceuticals, medical devices, biotechnology, aerospace, and food manufacturing. Founded in 2005 by Brant Engelhart, QT9 Software serves more than 1,000 customers globally through a unified platform integrating quality management (QMS), enterprise resource planning (ERP), and material requirements planning (MRP).

The platform includes more than 25 standard modules delivered in a pre-validated environment, with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols included. The vendor states implementation can be completed in under 30 days. QT9 QMS is built for compliance with FDA 21 CFR Parts 11, 210, 211, and 820, ISO 9001:2015, ISO 17025, AS9100, EU GMP Annex 11, and EU MDR requirements. On ISO 13485, QT9 describes the platform as making certification and audits easier for its customers; a QT9 ISO 13485 certificate is undisclosed.

Core quality management capabilities include document control with electronic signatures and version control, CAPA management with automated workflows linking nonconformances to investigations and corrective actions, and employee training management with automatic assignment and tracking. The platform also provides audit management for internal and supplier audits, change control with impact assessment and approval workflows, and risk management supporting ISO 14971 and ICH Q9 methodologies. Supplier quality evaluation, complaint handling, calibration management, and process performance monitoring are included as well.

For pharmaceutical manufacturers, QT9 offers electronic batch records (EBR) through integration with QT9 ERP, capturing real-time data from manufacturing steps and automatically linking deviations, change logs, and CAPAs. Records lock after approval with electronic signatures and provide audit-ready batch execution reviews. The system supports current Good Manufacturing Practices (cGMP) compliance for FDA 21 CFR Parts 210 and 211, ICH Q10 pharmaceutical quality system requirements, and PIC/S GMP standards.

QT9 QMS integrates natively with QT9 ERP to eliminate duplicate data entry between quality and operations systems. The platform is available as cloud-based SaaS or on-premise deployment, with centralized dashboards for real-time compliance monitoring, role-based access controls for multi-location organizations, and automated alerts for expiring documents, overdue training, or quality events requiring action.

QT9 QMS holds more than 16 awards from G2 and Gartner Digital Markets for Fall 2025, including Best ROI, Easiest to Use, Best Support, and Fastest Implementation. Its average rating across review platforms is 4.8/5. Named customers include Mitsubishi Electric, Shiseido, ZOLL Medical, Foxconn, and Meridian Bioscience; pharmaceutical customers include Vireo Health, Bellicum Pharmaceuticals, and Resolution Biosciences.

The pre-validation documentation is intended to reduce internal validation costs and accelerate FDA audit readiness. The company provides implementation support, training programs, and customer support from a team of more than 60 people. Pricing is based on concurrent user licenses starting at $40–50 per user per month.

Pharmaceutical Edition

QT9 QMS provides pharmaceutical-specific capabilities through dedicated pharmaceutical industry solutions with electronic batch records (EBR) via QT9 ERP integration, FDA 21 CFR Parts 11/210/211 compliance, pre-validated IQ/OQ/PQ protocols, ICH Q10 support, and PIC/S GMP compliance. Pharmaceutical customers include Vireo Health, Bellicum Pharmaceuticals, and Resolution Biosciences.

Key Features & Capabilities

Core Capabilities

Document Control - Electronic document management with version control, approval workflows, electronic signatures (21 CFR Part 11 compliant), and audit trails. Manage SOPs, work instructions, batch records, specifications, and validation protocols with real-time tracking and centralized access.

CAPA Management - Corrective and Preventive Action management with automated workflows linking nonconformances, deviations, and quality events to investigation and corrective action tracking. Includes root cause analysis tools, effectiveness verification, and integration with document control and training modules.

Electronic Batch Records (EBR) - Paperless batch manufacturing through QT9 ERP integration. Real-time data capture from manufacturing steps, automatic linking of deviations and change logs, electronic signature approval, and locked records post-approval for audit integrity. Supports cGMP compliance for FDA 21 CFR Parts 210/211.

Training Management - Employee qualification tracking with automatic training assignment based on role or process changes, electronic signature verification of training completion, expiration tracking with automated alerts, and audit-ready training records demonstrating GMP compliance.

Audit Management - Internal and external audit planning, execution, and follow-up. Schedule audits, assign auditors, document findings with photo attachments, track corrective actions, and maintain audit history for regulatory inspections. Supports supplier audits and self-inspections.

Change Control - Formal change management with impact assessment, approval workflows, documentation of rationale, and linkage to affected documents, training, and processes. Evaluates changes to validated systems, batch records, equipment, and procedures before implementation.

Risk Management - Risk assessment and mitigation supporting ISO 14971 (medical device risk) and ICH Q9 (pharmaceutical quality risk) methodologies. Includes risk identification, analysis, evaluation, control measures, and monitoring with linkage to CAPA and change control.

Supplier Quality Management - Supplier evaluation, qualification, and performance monitoring. Track supplier audits, certificates of analysis, nonconformances, and corrective actions. Maintain approved supplier lists and evaluate suppliers based on quality, delivery, and compliance metrics.

Nonconformance Management - Quality event reporting and investigation for nonconforming materials, processes, or products. Document root causes, disposition decisions (use-as-is, rework, scrap), and link to CAPA for systemic issues. Supports batch deviation tracking for pharma.

Complaint Management - Customer complaint intake, investigation, and resolution tracking. Categorize complaints by severity, link to batch records or nonconformances, document root cause and corrective action, and generate regulatory reports for FDA Medical Device Reporting (MDR) or adverse events.

Calibration Management - Equipment calibration scheduling, execution, and record-keeping. Track calibration due dates with automated alerts, document calibration results, maintain calibration certificates, and link out-of-tolerance findings to impact assessment and CAPA.

Inspection Management - Inspection planning and execution for equipment, facilities, processes, and receiving inspection. Record findings, assign corrective actions, and track completion. Supports GMP facility inspections and incoming material inspection.

Management Review - Structured management review meetings per ISO 9001 and ISO 13485 requirements. Aggregate quality metrics, CAPA status, audit findings, and customer feedback for executive review. Document management decisions and action items with follow-up tracking.

Real-Time Dashboards - Centralized compliance monitoring with role-based dashboards showing overdue CAPAs, expiring documents, pending training, audit findings, and quality metrics. Configurable widgets for different user roles and departments.

Electronic Signatures - 21 CFR Part 11 compliant electronic signatures for all record approvals, changes, and batch releases. User authentication with username/password, signature meaning (e.g., "Approved by", "Reviewed by"), and permanent audit trail of all signatures.

Audit Trails - Comprehensive, immutable audit trails for all system interactions. Every record change, access, approval, or deletion is date-stamped, time-stamped, and user-stamped. Audit trails cannot be modified and are available for regulatory inspection.

Pre-Validated Environment - Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols included with the platform. Reduces internal validation effort and accelerates FDA audit readiness for regulated pharmaceutical and medical device manufacturers.

ERP Integration - Native integration between QT9 QMS and QT9 ERP modules eliminates duplicate data entry. Quality events automatically link to batch records, inventory, and production data. Unified platform for quality, manufacturing, inventory, and supply chain management.

Regulatory Compliance

FDA & GxP Compliance

FDA 21 CFR Part 11

FDA CFR 210/211 (cGMP)

FDA Part 820 (QSR)

GxP Compliant

International Standards

EU GMP Annex 11

Security Certifications

ISO 27001

Data Integrity & Validation

Electronic Signatures

Immutable Audit Trail

Validation Documentation

Technical Specifications

QT9 QMS is available as cloud-based SaaS, the vendor's primary offering, or as an on-premise deployment for organizations with specific data residency or infrastructure requirements. Cloud deployment is hosted and managed by QT9 Software, with browser-based access requiring no local installation.

The platform integrates natively with QT9 ERP/MRP modules, eliminating duplicate data entry between quality and operations systems. API availability is undisclosed, and mobile access capabilities are unstated. The system supports role-based access controls for multi-location organizations, with centralized dashboards for real-time compliance monitoring across sites.

Pricing Information

Starting price is $40–50 per user per month ($480–600 per user annually) for businesses with up to 10 users, per third-party review platforms; standard pricing is listed at $50/user/month. Enterprise pricing for larger organizations or multi-site deployments is available by contacting sales. A free trial is available; no permanent free version is offered, subscription-based only.

Pricing uses a per-user subscription model based on concurrent user licenses, the number of simultaneous logins allowed rather than named users, which can provide cost savings over a per-named-user model when only a subset of employees requires simultaneous access. Pricing is aimed at small to mid-sized pharmaceutical and biotech companies pursuing FDA compliance.

Typical Deal Size

$50/user/month

Implementation Details

The vendor states standard implementation can be completed in under 30 days for core modules, including document control, CAPA, training management, and audit management. QT9 Software provides implementation support and training programs for administrators and end users, and received a G2 "Fastest Implementation" award in 2025.

The pre-validated environment, with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols included, is intended to reduce validation timeline and internal validation effort for FDA-regulated pharmaceutical and medical device manufacturers. Implementation timeline depends on organizational complexity, number of modules deployed, data migration requirements, and validation scope. Implementation services are provided by a QT9 team led by VP Operations.

What the Community Reports

Anonymous feedback from pharmaceutical professionals using this solution

4.8 out of 5

Based on 20 verified reviews

What Users Like

Users report ease of use, fast implementation, strong customer support, and value for price. Pharmaceutical users describe it as a "great option for entry into a computerized system for Quality" with "great functionality and pricing" that makes it accessible for smaller pharmaceutical and biotech companies. Cited strengths include the platform's versatility, robust features, its ability to streamline processes while reducing errors, a responsive support team rated 9.1/10 for support quality, its combined QMS-and-ERP role, and a pre-validated environment that reduces validation burden for regulated industries. The concurrent license pricing model is reported to reduce cost relative to per-named-user licensing. QT9 holds G2 awards for Best ROI, Easiest to Use, Best Support, and Fastest Implementation.

What Users Dislike

API availability for integration with third-party systems beyond native QT9 ERP/MRP modules is undisclosed. Mobile access capabilities for field-based quality operations are unstated. Funding history is undisclosed.