Quick Overview
- 1#1: MasterControl - Comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries.
- 2#2: ETQ Reliance - Highly configurable cloud-based QMS for enterprise-wide quality management, risk, and continuous improvement.
- 3#3: Qualio - Modern eQMS tailored for life sciences with streamlined workflows for document control, training, and CAPA.
- 4#4: Veeva QualityOne - Cloud QMS integrated with Veeva Vault for quality processes, audits, and compliance in life sciences.
- 5#5: Greenlight Guru - Purpose-built eQMS for medical device companies focusing on design controls, risk management, and FDA compliance.
- 6#6: ComplianceQuest - Salesforce-native QMS for CAPA, audits, complaints, supplier quality, and non-conformance management.
- 7#7: AssurX - Integrated QMS that automates quality event resolution, CAPA, and regulatory compliance across enterprises.
- 8#8: Ideagen Quality Management - Modular QMS suite for audits, incident management, risk assessment, and supplier compliance.
- 9#9: Intellect - No-code configurable QMS platform for automating inspections, CAPA, audits, and quality workflows.
- 10#10: QT9 QMS - Affordable cloud QMS with features for document control, training, non-conformances, and supplier management.
We evaluated tools based on feature depth, user experience, industry relevance, reliability, and value, ensuring they deliver actionable, scalable solutions for modern quality management challenges.
Comparison Table
Navigating the landscape of Quality Management System (QMS) software is key for modern organizations aiming to enhance compliance, collaboration, and operational efficiency; this comparison table details top tools like MasterControl, ETQ Reliance, Qualio, Veeva QualityOne, Greenlight Guru, and more, outlining their core features, industry focus, and unique capabilities to help readers find the right fit for their needs.
| # | Tool | Category | Overall | Features | Ease of Use | Value |
|---|---|---|---|---|---|---|
| 1 | MasterControl Comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries. | enterprise | 9.4/10 | 9.6/10 | 8.7/10 | 9.0/10 |
| 2 | ETQ Reliance Highly configurable cloud-based QMS for enterprise-wide quality management, risk, and continuous improvement. | enterprise | 9.2/10 | 9.5/10 | 8.7/10 | 8.9/10 |
| 3 | Qualio Modern eQMS tailored for life sciences with streamlined workflows for document control, training, and CAPA. | specialized | 8.7/10 | 9.0/10 | 9.2/10 | 8.0/10 |
| 4 | Veeva QualityOne Cloud QMS integrated with Veeva Vault for quality processes, audits, and compliance in life sciences. | enterprise | 8.7/10 | 9.4/10 | 8.1/10 | 8.2/10 |
| 5 | Greenlight Guru Purpose-built eQMS for medical device companies focusing on design controls, risk management, and FDA compliance. | specialized | 8.7/10 | 9.2/10 | 8.5/10 | 8.0/10 |
| 6 | ComplianceQuest Salesforce-native QMS for CAPA, audits, complaints, supplier quality, and non-conformance management. | enterprise | 8.3/10 | 8.7/10 | 7.6/10 | 8.0/10 |
| 7 | AssurX Integrated QMS that automates quality event resolution, CAPA, and regulatory compliance across enterprises. | enterprise | 8.1/10 | 8.7/10 | 7.2/10 | 7.8/10 |
| 8 | Ideagen Quality Management Modular QMS suite for audits, incident management, risk assessment, and supplier compliance. | enterprise | 8.3/10 | 8.7/10 | 7.6/10 | 8.0/10 |
| 9 | Intellect No-code configurable QMS platform for automating inspections, CAPA, audits, and quality workflows. | enterprise | 8.7/10 | 9.2/10 | 8.4/10 | 8.0/10 |
| 10 | QT9 QMS Affordable cloud QMS with features for document control, training, non-conformances, and supplier management. | enterprise | 8.4/10 | 8.7/10 | 8.5/10 | 8.2/10 |
Comprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries.
Highly configurable cloud-based QMS for enterprise-wide quality management, risk, and continuous improvement.
Modern eQMS tailored for life sciences with streamlined workflows for document control, training, and CAPA.
Cloud QMS integrated with Veeva Vault for quality processes, audits, and compliance in life sciences.
Purpose-built eQMS for medical device companies focusing on design controls, risk management, and FDA compliance.
Salesforce-native QMS for CAPA, audits, complaints, supplier quality, and non-conformance management.
Integrated QMS that automates quality event resolution, CAPA, and regulatory compliance across enterprises.
Modular QMS suite for audits, incident management, risk assessment, and supplier compliance.
No-code configurable QMS platform for automating inspections, CAPA, audits, and quality workflows.
Affordable cloud QMS with features for document control, training, non-conformances, and supplier management.
MasterControl
enterpriseComprehensive QMS platform for document control, CAPA, audits, training, and compliance in regulated industries.
Connected Quality platform that unifies disconnected quality processes across the entire value chain for holistic visibility and control
MasterControl is a comprehensive cloud-based Quality Management System (QMS) software tailored for regulated industries like life sciences, manufacturing, and medical devices. It offers an integrated suite of modules for document control, CAPA, audit management, training, complaints, and supplier management, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The platform automates workflows, provides real-time analytics, and supports digital transformation to reduce risks and improve operational efficiency.
Pros
- Extensive compliance tools with pre-built validations for FDA and ISO standards
- Scalable architecture supporting global enterprises with seamless integrations
- Advanced automation and AI-driven insights for proactive quality management
Cons
- High implementation costs and lengthy onboarding for complex deployments
- Steep learning curve for non-technical users despite intuitive interfaces
- Customization often requires professional services
Best For
Large enterprises in highly regulated industries needing an end-to-end, compliant QMS platform.
Pricing
Custom enterprise pricing via quote; subscription model typically starts at $50,000+ annually based on users, modules, and deployment scale.
ETQ Reliance
enterpriseHighly configurable cloud-based QMS for enterprise-wide quality management, risk, and continuous improvement.
No-code Dynamic Workflow Builder enabling infinite customization of quality processes without developer involvement
ETQ Reliance is a cloud-based Quality Management System (QMS) software that provides end-to-end solutions for managing quality processes, including audits, CAPA, complaints, document control, supplier management, and training. It excels in regulated industries like manufacturing, life sciences, and automotive by ensuring compliance with standards such as ISO 9001, FDA 21 CFR Part 11, and IATF 16949. The platform's no-code configurability allows users to tailor workflows, forms, and dashboards to specific business needs, while AI-powered analytics deliver actionable insights for continuous improvement.
Pros
- Highly configurable no-code platform for custom workflows and forms
- Comprehensive modules with strong compliance and risk management tools
- Advanced AI-driven analytics and real-time reporting for proactive quality control
Cons
- Higher pricing suitable mainly for mid-to-large enterprises
- Initial implementation and configuration can be time-intensive
- Learning curve for maximizing advanced customization features
Best For
Mid-to-large enterprises in regulated industries like manufacturing and life sciences needing a scalable, highly customizable QMS.
Pricing
Custom quote-based pricing; annual subscriptions typically start at $30,000+ for smaller deployments, scaling to $100,000+ for enterprise with full modules and users.
Qualio
specializedModern eQMS tailored for life sciences with streamlined workflows for document control, training, and CAPA.
Connected quality lifecycle that unifies documents, training, CAPA, and change control in one platform for end-to-end automation
Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, streamlining document control, training, CAPA, non-conformances, audits, and supplier management. It ensures compliance with FDA 21 CFR Part 11, ISO 13485, EU MDR, and other regulations through automated workflows and electronic signatures. Qualio's modern interface fosters collaboration between quality and R&D teams, enabling faster product launches with reduced administrative burden.
Pros
- Intuitive, modern UI with minimal training required
- Robust compliance tools and audit-ready reporting
- Fast implementation and seamless scalability for growing teams
Cons
- Higher pricing may deter very small startups
- Primarily optimized for life sciences, less flexible for non-regulated industries
- Advanced custom reporting often needs add-ons or integrations
Best For
Mid-sized life sciences and biotech firms needing a user-friendly, compliant eQMS to accelerate quality processes without heavy IT overhead.
Pricing
Custom pricing upon request; typically starts at $1,200/month for 10 users, with tiers scaling to enterprise levels based on features and users.
Veeva QualityOne
enterpriseCloud QMS integrated with Veeva Vault for quality processes, audits, and compliance in life sciences.
Unified platform integration with Veeva Vault QualityDocs for a single source of truth across quality processes and controlled documents
Veeva QualityOne is a cloud-native Quality Management System (QMS) tailored for life sciences industries, including pharmaceuticals, biotech, and medical devices. It streamlines end-to-end quality processes such as CAPA, complaints handling, audits, training, document control, supplier management, and risk assessments. Deeply integrated with Veeva Vault, it ensures regulatory compliance with standards like FDA 21 CFR Part 11, EU Annex 11, and ISO 13485, while offering configurable workflows and real-time analytics.
Pros
- Highly specialized for life sciences with robust compliance tools and validation support
- Seamless integration with Veeva Vault for unified document and quality management
- Mobile-first design with AI-driven insights for proactive quality risk management
Cons
- Enterprise pricing is opaque and expensive, best suited for large organizations
- Steeper learning curve due to industry-specific complexity and configurations
- Less flexible for non-life sciences industries without heavy customization
Best For
Mid-to-large life sciences companies needing a compliant, scalable QMS integrated with content management systems.
Pricing
Subscription-based enterprise pricing; starts at $50,000+ annually depending on modules, users, and deployment—contact sales for quote.
Greenlight Guru
specializedPurpose-built eQMS for medical device companies focusing on design controls, risk management, and FDA compliance.
Built-in medtech-specific risk register with automated linkages to design history files and quality events
Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies. It streamlines compliance with standards like ISO 13485, FDA 21 CFR Part 820, and EU MDR through integrated modules for document control, CAPA, risk management, audits, training, and design controls. The software emphasizes traceability and connectivity across the product lifecycle, reducing manual work and audit risks.
Pros
- Highly specialized for medtech regulations and workflows
- Excellent traceability linking design controls to quality events
- Modern, intuitive interface with strong collaboration tools
Cons
- Premium pricing may be prohibitive for small startups
- Primarily focused on life sciences, less flexible for other industries
- Initial setup and customization require expertise
Best For
Medical device manufacturers prioritizing regulatory compliance and integrated quality processes.
Pricing
Quote-based subscription starting at around $20,000 annually for small teams, scaling with users and modules.
ComplianceQuest
enterpriseSalesforce-native QMS for CAPA, audits, complaints, supplier quality, and non-conformance management.
Native Salesforce platform integration enabling seamless QMS-CRM unification
ComplianceQuest is a cloud-based Quality Management System (QMS) software built natively on the Salesforce platform, designed to streamline compliance, quality processes, and risk management for regulated industries. It offers comprehensive modules for CAPA, audits, complaints handling, document control, supplier quality, nonconformance, and training management. The platform leverages Salesforce's scalability and no-code customization to integrate quality workflows seamlessly with CRM and other enterprise systems.
Pros
- Native integration with Salesforce CRM for unified operations
- Highly customizable workflows without extensive coding
- Robust compliance tools tailored for regulated industries like life sciences and manufacturing
Cons
- Steep learning curve due to Salesforce foundation
- Custom pricing can be expensive for smaller teams
- Lengthy implementation and setup process
Best For
Mid-to-large enterprises in highly regulated sectors needing scalable QMS integrated with Salesforce CRM.
Pricing
Custom enterprise pricing, typically starting at $100+ per user per month based on modules, users, and implementation needs; quotes required.
AssurX
enterpriseIntegrated QMS that automates quality event resolution, CAPA, and regulatory compliance across enterprises.
Patented interconnected process engine that links quality events across CAPA, complaints, audits, and training for holistic risk management
AssurX is a robust enterprise Quality Management System (QMS) software tailored for highly regulated industries like life sciences, manufacturing, and medical devices. It streamlines processes such as CAPA management, complaint handling, audits, training, supplier quality, and risk assessment with configurable workflows and real-time analytics. The platform ensures compliance with standards like FDA 21 CFR Part 11, ISO 13485, and GxP through automated controls and audit trails.
Pros
- Highly configurable workflows that adapt to specific business processes
- Strong compliance tools with built-in support for regulatory standards and e-signatures
- Excellent integration capabilities with ERP, LIMS, and other enterprise systems
Cons
- Steep learning curve and complex initial setup requiring significant training
- Enterprise pricing model lacks transparency and can be costly for mid-sized firms
- User interface feels dated compared to modern SaaS QMS solutions
Best For
Large enterprises in regulated industries such as pharmaceuticals and medical devices that require deeply customizable compliance management.
Pricing
Custom enterprise licensing with quote-based pricing; typically starts at $50,000+ annually depending on modules and users.
Ideagen Quality Management
enterpriseModular QMS suite for audits, incident management, risk assessment, and supplier compliance.
Integrated risk-based auditing that links quality events directly to enterprise risk management for proactive compliance.
Ideagen Quality Management is a robust, cloud-based Quality Management System (QMS) software suite that helps organizations in regulated industries manage compliance, audits, corrective actions, and continuous improvement processes. It provides modular tools for document control, non-conformance tracking, CAPA management, supplier quality, and risk assessment, all integrated into a unified platform. The solution emphasizes automation, real-time reporting, and scalability for complex quality workflows.
Pros
- Comprehensive modular toolkit covering full QMS lifecycle from audits to CAPA
- Strong compliance support for standards like ISO 9001, FDA, and AS9100
- Advanced analytics and customizable dashboards for actionable insights
Cons
- Steep learning curve due to extensive customization options
- Interface feels somewhat dated compared to modern SaaS competitors
- Pricing can be prohibitive for small to mid-sized organizations
Best For
Mid-to-large enterprises in highly regulated sectors like manufacturing, aerospace, and pharmaceuticals needing scalable, compliance-focused QMS.
Pricing
Quote-based enterprise pricing; typically starts at $5,000+ annually for basic modules, scaling with users and add-ons.
Intellect
enterpriseNo-code configurable QMS platform for automating inspections, CAPA, audits, and quality workflows.
Patented no-code eTNQA (electronic Techno-Native QMS Apps) builder for rapid deployment of tailored quality applications
Intellect is a cloud-based Quality Management System (QMS) platform designed for regulated industries like life sciences, manufacturing, and aerospace. It provides a comprehensive suite of modules for CAPA, audits, complaints, document control, supplier management, training, and risk management, all configurable without coding. The platform emphasizes compliance with standards such as ISO 9001, FDA 21 CFR Part 11, and GDPR through automated workflows and robust reporting.
Pros
- Highly configurable no-code platform for custom workflows
- Comprehensive QMS module library covering all key processes
- Strong compliance tools with e-signatures and audit trails
Cons
- Pricing can be steep for smaller organizations
- Initial setup and configuration require expertise
- Limited out-of-the-box integrations with some ERP systems
Best For
Mid-to-large enterprises in highly regulated industries needing a flexible, scalable QMS solution.
Pricing
Custom enterprise pricing, typically starting at $100/user/month or $20,000+ annually based on modules and users.
QT9 QMS
enterpriseAffordable cloud QMS with features for document control, training, non-conformances, and supplier management.
Unlimited users, storage, and custom forms with zero additional fees, enabling cost-effective scaling for any team size.
QT9 QMS is a fully web-based Quality Management System software tailored for manufacturers, enabling streamlined management of quality processes including document control, CAPA, audits, training, and supplier management. It supports compliance with standards like ISO 9001, AS9100, and IATF 16949 through modular tools that automate workflows and reporting. The platform emphasizes scalability with no limits on users, storage, or forms, making it suitable for growing organizations without hidden costs.
Pros
- Unlimited users, storage, and forms included at no extra charge
- Comprehensive modular design covering all core QMS needs
- Intuitive dashboards and mobile accessibility for real-time tracking
Cons
- Pricing requires custom quotes with less transparency
- Limited native integrations with ERP or other enterprise systems
- Advanced customization may need professional services
Best For
Small to mid-sized manufacturers seeking an affordable, scalable QMS with strong compliance tools and no user limits.
Pricing
Custom pricing via quote, typically starting at $1,500/month for base modules, scaling with add-ons; unlimited users included.
Conclusion
The reviewed quality management system tools showcase diverse strengths, with each addressing specific industry needs—from regulated sectors to cloud-native efficiency. MasterControl leads as the top choice, offering a comprehensive platform for cross-industry compliance, document control, and continuous improvement. ETQ Reliance and Qualio follow as strong alternatives, with the former excelling in enterprise configurability and the latter tailored for life sciences workflows, ensuring robust support across varied operational requirements.
Take the next step in enhancing your quality management by exploring MasterControl—its unified suite is designed to streamline processes, boost compliance, and drive consistent growth for any regulated or dynamic organization.
Tools Reviewed
All tools were independently evaluated for this comparison