Quick Overview
- 1#1: MasterControl - Delivers a comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries.
- 2#2: ETQ Reliance - Offers a configurable, no-code quality management system for automating processes like audits, complaints, and supplier quality across enterprises.
- 3#3: Qualio - Provides a modern, cloud-based eQMS tailored for life sciences to streamline quality documentation, workflows, and regulatory compliance.
- 4#4: ComplianceQuest - Builds an end-to-end QMS on the Salesforce platform for managing quality events, CAPA, audits, and customer complaints.
- 5#5: Greenlight Guru - Specializes in medtech QMS software for design controls, risk management, and quality processes in medical device development.
- 6#6: AssurX - Delivers integrated QMS for aviation, life sciences, and manufacturing with real-time quality event management and analytics.
- 7#7: Ideagen Quality Management - Provides quality assurance software for audits, CAPA, non-conformances, and supplier management in various industries.
- 8#8: QAD EQMS - Integrates quality management within ERP for manufacturing, handling inspections, complaints, and continuous improvement.
- 9#9: Unipoint - Offers a centralized QMS platform for tracking non-conformances, CAPA, audits, and quality metrics in manufacturing.
- 10#10: QT9 QMS - Supplies an affordable, configurable QMS with over 30 modules for document control, training, and quality workflows.
These tools were selected based on feature robustness, user experience, and overall value, prioritizing capability to address key quality workflows like document control, CAPA, and compliance, while accommodating both regulated and general manufacturing sectors.
Comparison Table
Navigating product quality management software? This comparison table explores leading tools including MasterControl, ETQ Reliance, Qualio, ComplianceQuest, Greenlight Guru, and more, breaking down key features and practical use cases to help you find the right fit for your organization’s needs.
| # | Tool | Category | Overall | Features | Ease of Use | Value |
|---|---|---|---|---|---|---|
| 1 | MasterControl Delivers a comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries. | enterprise | 9.4/10 | 9.8/10 | 8.1/10 | 8.6/10 |
| 2 | ETQ Reliance Offers a configurable, no-code quality management system for automating processes like audits, complaints, and supplier quality across enterprises. | enterprise | 9.2/10 | 9.6/10 | 8.4/10 | 8.7/10 |
| 3 | Qualio Provides a modern, cloud-based eQMS tailored for life sciences to streamline quality documentation, workflows, and regulatory compliance. | specialized | 9.2/10 | 9.4/10 | 9.5/10 | 8.7/10 |
| 4 | ComplianceQuest Builds an end-to-end QMS on the Salesforce platform for managing quality events, CAPA, audits, and customer complaints. | enterprise | 8.6/10 | 9.2/10 | 7.8/10 | 8.1/10 |
| 5 | Greenlight Guru Specializes in medtech QMS software for design controls, risk management, and quality processes in medical device development. | specialized | 9.0/10 | 9.5/10 | 8.3/10 | 7.9/10 |
| 6 | AssurX Delivers integrated QMS for aviation, life sciences, and manufacturing with real-time quality event management and analytics. | enterprise | 8.0/10 | 8.7/10 | 7.2/10 | 7.8/10 |
| 7 | Ideagen Quality Management Provides quality assurance software for audits, CAPA, non-conformances, and supplier management in various industries. | enterprise | 8.2/10 | 8.7/10 | 7.6/10 | 7.9/10 |
| 8 | QAD EQMS Integrates quality management within ERP for manufacturing, handling inspections, complaints, and continuous improvement. | enterprise | 8.2/10 | 8.7/10 | 7.8/10 | 8.0/10 |
| 9 | Unipoint Offers a centralized QMS platform for tracking non-conformances, CAPA, audits, and quality metrics in manufacturing. | enterprise | 8.1/10 | 8.7/10 | 7.4/10 | 7.8/10 |
| 10 | QT9 QMS Supplies an affordable, configurable QMS with over 30 modules for document control, training, and quality workflows. | other | 8.3/10 | 8.5/10 | 8.8/10 | 8.2/10 |
Delivers a comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries.
Offers a configurable, no-code quality management system for automating processes like audits, complaints, and supplier quality across enterprises.
Provides a modern, cloud-based eQMS tailored for life sciences to streamline quality documentation, workflows, and regulatory compliance.
Builds an end-to-end QMS on the Salesforce platform for managing quality events, CAPA, audits, and customer complaints.
Specializes in medtech QMS software for design controls, risk management, and quality processes in medical device development.
Delivers integrated QMS for aviation, life sciences, and manufacturing with real-time quality event management and analytics.
Provides quality assurance software for audits, CAPA, non-conformances, and supplier management in various industries.
Integrates quality management within ERP for manufacturing, handling inspections, complaints, and continuous improvement.
Offers a centralized QMS platform for tracking non-conformances, CAPA, audits, and quality metrics in manufacturing.
Supplies an affordable, configurable QMS with over 30 modules for document control, training, and quality workflows.
MasterControl
enterpriseDelivers a comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries.
Connected Quality platform unifying all QMS processes into a single, automated workflow
MasterControl is a comprehensive enterprise quality management system (eQMS) tailored for regulated industries like life sciences, manufacturing, and medical devices. It centralizes processes such as document control, CAPA, audit management, training, complaints, and supplier quality in a single, compliant platform. The software ensures adherence to standards like FDA 21 CFR Part 11, ISO 13485, and GxP through automation, real-time analytics, and seamless integrations.
Pros
- Robust compliance tools with built-in validation and electronic signatures
- Scalable, modular architecture supporting global enterprises
- Extensive integrations with ERP, LIMS, and MES systems
Cons
- Steep learning curve and lengthy implementation for complex setups
- High cost prohibitive for small organizations
- Customization requires professional services
Best For
Large, regulated enterprises in pharma, biotech, and medtech prioritizing compliance and process automation.
Pricing
Quote-based enterprise pricing; typically starts at $50,000+ annually depending on modules, users, and deployment.
ETQ Reliance
enterpriseOffers a configurable, no-code quality management system for automating processes like audits, complaints, and supplier quality across enterprises.
No-code configuration engine enabling full workflow customization without developers
ETQ Reliance is a robust, cloud-based Quality Management System (QMS) software that automates and streamlines product quality processes including CAPA, audits, complaints, supplier management, document control, and non-conformance handling. It excels in regulated industries by providing configurable workflows, real-time analytics, and compliance tools for standards like ISO 9001, FDA 21 CFR Part 11, and IATF 16949. The platform's no-code configuration allows users to tailor it to specific business needs without programming expertise.
Pros
- Highly configurable no-code platform for custom workflows
- Comprehensive QMS modules with strong compliance support
- Advanced analytics and reporting via Illuminator dashboard
Cons
- Steep initial learning curve for full customization
- Enterprise-level pricing not ideal for small businesses
- Interface feels dated compared to newer SaaS tools
Best For
Mid-to-large enterprises in regulated industries like manufacturing, life sciences, and automotive needing a scalable, compliant QMS.
Pricing
Quote-based subscription pricing; typically starts at $50,000+ annually depending on users, modules, and deployment size.
Qualio
specializedProvides a modern, cloud-based eQMS tailored for life sciences to streamline quality documentation, workflows, and regulatory compliance.
No-code configurability for tailoring quality workflows without developers or scripting
Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, streamlining processes like document control, training, CAPA, audits, supplier management, and change control. It ensures compliance with FDA 21 CFR Part 11, ISO 13485, and other regulations through automated workflows and electronic signatures. With no-code customization and integrations with tools like Google Workspace and Microsoft Office, Qualio enables rapid deployment and scalability for quality teams.
Pros
- Intuitive, modern interface with no-code workflow customization
- Deep compliance tools purpose-built for life sciences
- Quick implementation and strong integrations with productivity apps
Cons
- Pricing can be steep for very small teams
- Primarily optimized for regulated industries like biotech/pharma
- Advanced reporting requires higher-tier plans
Best For
Life sciences startups and mid-sized companies needing a scalable, compliant eQMS with minimal IT overhead.
Pricing
Quote-based pricing starting around $1,200/month for small teams, scaling with users, modules, and storage.
ComplianceQuest
enterpriseBuilds an end-to-end QMS on the Salesforce platform for managing quality events, CAPA, audits, and customer complaints.
Native Salesforce platform integration, enabling unified quality management with CRM, service, and field operations data
ComplianceQuest is a cloud-based eQMS platform built natively on Salesforce, designed for regulated industries to manage quality processes like CAPA, audits, complaints, nonconformance, and document control. It ensures compliance with standards such as FDA 21 CFR Part 11, ISO 13485, and IATF 16949 through automated workflows and traceability. Leveraging Salesforce's infrastructure, it offers seamless integration with CRM and ERP systems for a unified view of quality and operations.
Pros
- Comprehensive QMS modules with strong regulatory compliance tools
- Native Salesforce integration for scalability and customization
- Advanced analytics and AI-driven insights for proactive quality management
Cons
- Steep learning curve due to Salesforce foundation
- Higher pricing suitable mainly for mid-to-large enterprises
- Lengthy implementation and setup process
Best For
Mid-to-large organizations in regulated sectors like life sciences, medical devices, and automotive needing integrated quality and CRM management.
Pricing
Custom quote-based pricing; typically starts at $75-$100/user/month, scaling with modules and users for enterprise deployments.
Greenlight Guru
specializedSpecializes in medtech QMS software for design controls, risk management, and quality processes in medical device development.
Exclusive focus on medical devices with built-in design controls and risk management tightly integrated for full lifecycle traceability.
Greenlight Guru is a cloud-based eQMS platform specifically designed for the medical device industry, helping companies manage quality processes from design controls to post-market surveillance. It offers integrated modules for document control, risk management (ISO 14971), CAPA, audits, training, and complaints, all tailored to FDA 21 CFR Part 820 and ISO 13485 compliance. The software streamlines regulatory submissions like 510(k) and ensures traceability across the product lifecycle.
Pros
- Purpose-built for medical devices with deep regulatory compliance tools
- Intuitive interface and strong automation for workflows like CAPA and risk management
- Excellent traceability and reporting for audits and submissions
Cons
- High pricing suitable only for mid-to-large companies
- Limited flexibility for non-medical device industries
- Steeper learning curve for advanced customization
Best For
Medical device manufacturers prioritizing FDA and ISO 13485 compliance in their quality management.
Pricing
Custom enterprise pricing; typically starts at $10,000+ annually, scaling with users and modules.
AssurX
enterpriseDelivers integrated QMS for aviation, life sciences, and manufacturing with real-time quality event management and analytics.
Universal Workflow Engine enabling no-code configuration of intricate, industry-specific quality processes
AssurX is a configurable enterprise quality management system (eQMS) designed for regulated industries like life sciences, manufacturing, and insurance. It streamlines quality event management, complaints, CAPA, audits, risk assessments, and compliance tracking through automated workflows and analytics. The platform emphasizes deep customization to fit complex business processes while ensuring regulatory adherence such as FDA, ISO, and SOX.
Pros
- Highly configurable no-code workflows for complex quality processes
- Strong compliance and risk management tools tailored for regulated industries
- Robust analytics and reporting for actionable insights
Cons
- Steep learning curve due to extensive customization options
- High implementation and ongoing costs for enterprise-scale deployments
- Less intuitive for small teams without dedicated IT support
Best For
Large enterprises in highly regulated sectors like pharmaceuticals, medical devices, and manufacturing needing a flexible, scalable QMS.
Pricing
Custom quote-based pricing; modular subscriptions typically start at $50,000+ annually for mid-sized deployments, scaling with users and modules.
Ideagen Quality Management
enterpriseProvides quality assurance software for audits, CAPA, non-conformances, and supplier management in various industries.
Seamless integration of quality management with EHS compliance in a single platform
Ideagen Quality Management is a robust enterprise-grade Quality Management System (QMS) software suite that helps organizations manage compliance, audits, corrective and preventive actions (CAPA), document control, and risk assessments. It integrates quality processes with EHS (Environment, Health, and Safety) functionalities for a holistic approach to operational excellence. Targeted at regulated industries, it supports ISO standards and drives continuous improvement through configurable workflows and reporting tools.
Pros
- Comprehensive compliance and audit management tools
- Scalable for large enterprises with strong integration capabilities
- Robust CAPA and risk management modules
Cons
- Steep learning curve and dated interface in some areas
- Complex implementation requiring significant setup time
- Pricing lacks transparency and can be costly for smaller teams
Best For
Mid-to-large enterprises in regulated industries like manufacturing, pharma, and aerospace needing integrated EHSQ solutions.
Pricing
Custom quote-based enterprise licensing, typically subscription model starting at $5,000+ annually depending on modules and users.
QAD EQMS
enterpriseIntegrates quality management within ERP for manufacturing, handling inspections, complaints, and continuous improvement.
Native, bidirectional integration with QAD Enterprise Applications for real-time quality data synchronization
QAD EQMS is an enterprise-grade Quality Management System tailored for manufacturing companies, offering end-to-end tools for quality planning, control, assurance, and continuous improvement. It handles critical processes like CAPA, audits, complaints, non-conformances, supplier quality, and inspections with real-time analytics and reporting. Deeply integrated with QAD's ERP suite, it ensures seamless data flow across supply chain and production operations.
Pros
- Seamless integration with QAD ERP for unified operations
- Comprehensive modules covering full quality lifecycle
- Robust analytics and real-time visibility into quality metrics
Cons
- Steep learning curve due to enterprise complexity
- Optimized primarily for QAD ecosystem users
- Custom pricing can be opaque and high for smaller firms
Best For
Mid-to-large manufacturers already using QAD ERP who require integrated, scalable quality management.
Pricing
Custom enterprise subscription pricing; contact QAD for quotes based on users, modules, and deployment.
Unipoint
enterpriseOffers a centralized QMS platform for tracking non-conformances, CAPA, audits, and quality metrics in manufacturing.
No-code configurable workflows and forms for rapid adaptation to specific quality processes
UniPoint is a robust Quality Management System (QMS) software tailored for manufacturers, offering modules for CAPA, audits, supplier quality management, customer complaints, document control, and training tracking. It enables compliance with standards like ISO 9001, IATF 16949, and FDA regulations through automated workflows and real-time reporting. The platform emphasizes risk-based thinking and continuous improvement, integrating seamlessly with ERP systems for enhanced data flow.
Pros
- Comprehensive QMS modules covering end-to-end quality processes
- Highly configurable workflows without extensive coding
- Strong integration capabilities with ERP and MES systems
Cons
- Dated user interface compared to modern competitors
- Steep learning curve for full customization and setup
- Pricing can be prohibitive for small businesses
Best For
Mid-sized manufacturers in regulated industries needing a scalable, configurable QMS for complex compliance and supplier management.
Pricing
Custom quote-based pricing, typically starting at $500-$1,000 per month for mid-tier plans with per-user scaling.
QT9 QMS
otherSupplies an affordable, configurable QMS with over 30 modules for document control, training, and quality workflows.
Unlimited users at a flat rate, eliminating cost barriers for team growth
QT9 QMS is a cloud-based quality management system software tailored for manufacturing and regulated industries like medical devices and aerospace. It offers modules for document control, audits, CAPA, supplier management, nonconformance tracking, training, and complaints to ensure compliance with ISO 9001, FDA, and other standards. The platform provides real-time dashboards, automated workflows, and mobile access to streamline quality processes and reduce manual errors.
Pros
- Unlimited users with no per-user fees, ideal for scaling teams
- Fully configurable without coding or IT support
- Comprehensive modules covering full QMS needs like CAPA and audits
Cons
- Custom pricing lacks transparency and can escalate for advanced modules
- Integrations limited compared to enterprise competitors
- Reporting tools require some setup for complex custom needs
Best For
Mid-sized manufacturers in regulated industries seeking an affordable, user-friendly all-in-one QMS without per-user costs.
Pricing
Custom subscription quotes starting at ~$1,500-$3,000/month for unlimited users, based on modules and company size; no setup fees.
Conclusion
The roundup of top product quality management software confirms MasterControl as the leading choice, boasting a comprehensive QMS for document control, CAPA, and compliance across regulated sectors. ETQ Reliance follows closely, offering a configurable, no-code system that streamlines audits, complaints, and supplier quality for enterprises, while Qualio distinguishes itself with a modern, cloud-based eQMS optimized for life sciences. Each tool excels in distinct areas, collectively setting the benchmark for effective quality management.
Take the next step: explore MasterControl to harness its full range of features and enhance your quality processes and compliance efficiency.
Tools Reviewed
All tools were independently evaluated for this comparison