Quick Overview
- 1#1: MasterControl - Provides a comprehensive quality management system with advanced audit tracking, CAPA, and compliance tools for regulated industries.
- 2#2: ETQ Reliance - Delivers flexible enterprise quality management software with robust audit management, risk assessment, and real-time analytics.
- 3#3: Qualio - Offers a modern eQMS platform designed for quality audits, document control, and compliance in life sciences.
- 4#4: AuditBoard - Streamlines audit, risk, and compliance processes with connected risk management and SOX compliance tools.
- 5#5: TeamMate+ - Provides end-to-end audit management software for planning, fieldwork, and reporting in internal audits.
- 6#6: Hyperproof - Automates compliance operations and audits with evidence collection, control mapping, and risk monitoring.
- 7#7: ComplianceQuest - Delivers Salesforce-powered QMS for quality audits, CAPA, and supplier management.
- 8#8: AssurX - Manages quality events, audits, and compliance with integrated workflow automation.
- 9#9: MetricStream - Offers an integrated GRC platform with quality audit, risk, and policy management capabilities.
- 10#10: Archer IRM - Provides a unified risk management platform supporting quality audits, assessments, and regulatory compliance.
Tools were ranked based on comprehensive feature sets (including audit tracking, compliance management, and risk integration), user-centric design, reliability, and overall value, ensuring alignment with the demands of modern regulated environments.
Comparison Table
Quality audit software simplifies compliance and operational oversight, with options varying in features, scalability, and industry focus. This comparison table outlines top tools like MasterControl, ETQ Reliance, Qualio, AuditBoard, and TeamMate+ to help readers evaluate suitability for their organization’s unique workflows and needs.
| # | Tool | Category | Overall | Features | Ease of Use | Value |
|---|---|---|---|---|---|---|
| 1 | MasterControl Provides a comprehensive quality management system with advanced audit tracking, CAPA, and compliance tools for regulated industries. | enterprise | 9.5/10 | 9.8/10 | 8.2/10 | 9.0/10 |
| 2 | ETQ Reliance Delivers flexible enterprise quality management software with robust audit management, risk assessment, and real-time analytics. | enterprise | 9.2/10 | 9.6/10 | 8.4/10 | 8.7/10 |
| 3 | Qualio Offers a modern eQMS platform designed for quality audits, document control, and compliance in life sciences. | specialized | 8.6/10 | 8.8/10 | 9.1/10 | 8.0/10 |
| 4 | AuditBoard Streamlines audit, risk, and compliance processes with connected risk management and SOX compliance tools. | enterprise | 8.7/10 | 9.2/10 | 8.4/10 | 7.9/10 |
| 5 | TeamMate+ Provides end-to-end audit management software for planning, fieldwork, and reporting in internal audits. | enterprise | 8.2/10 | 8.9/10 | 7.4/10 | 7.7/10 |
| 6 | Hyperproof Automates compliance operations and audits with evidence collection, control mapping, and risk monitoring. | enterprise | 8.3/10 | 9.0/10 | 8.0/10 | 7.5/10 |
| 7 | ComplianceQuest Delivers Salesforce-powered QMS for quality audits, CAPA, and supplier management. | enterprise | 8.2/10 | 8.7/10 | 7.6/10 | 7.9/10 |
| 8 | AssurX Manages quality events, audits, and compliance with integrated workflow automation. | enterprise | 8.0/10 | 8.4/10 | 7.6/10 | 7.8/10 |
| 9 | MetricStream Offers an integrated GRC platform with quality audit, risk, and policy management capabilities. | enterprise | 8.2/10 | 9.1/10 | 7.4/10 | 7.8/10 |
| 10 | Archer IRM Provides a unified risk management platform supporting quality audits, assessments, and regulatory compliance. | enterprise | 8.2/10 | 9.1/10 | 7.3/10 | 7.8/10 |
Provides a comprehensive quality management system with advanced audit tracking, CAPA, and compliance tools for regulated industries.
Delivers flexible enterprise quality management software with robust audit management, risk assessment, and real-time analytics.
Offers a modern eQMS platform designed for quality audits, document control, and compliance in life sciences.
Streamlines audit, risk, and compliance processes with connected risk management and SOX compliance tools.
Provides end-to-end audit management software for planning, fieldwork, and reporting in internal audits.
Automates compliance operations and audits with evidence collection, control mapping, and risk monitoring.
Delivers Salesforce-powered QMS for quality audits, CAPA, and supplier management.
Manages quality events, audits, and compliance with integrated workflow automation.
Offers an integrated GRC platform with quality audit, risk, and policy management capabilities.
Provides a unified risk management platform supporting quality audits, assessments, and regulatory compliance.
MasterControl
enterpriseProvides a comprehensive quality management system with advanced audit tracking, CAPA, and compliance tools for regulated industries.
Connected Process Automation that links audits directly to CAPA, nonconformance, and training for proactive, closed-loop quality control.
MasterControl is a leading enterprise Quality Management System (QMS) platform specializing in audit management for regulated industries like life sciences and manufacturing. It streamlines the entire audit lifecycle—from planning and scheduling to execution, evidence collection, findings tracking, and corrective action integration—ensuring compliance with standards such as FDA 21 CFR Part 11, ISO 13485, and SOX. The software provides real-time dashboards, automated workflows, and advanced reporting to minimize risks and accelerate audit closure.
Pros
- Comprehensive audit workflows with electronic signatures and mobile access
- Seamless integration across full QMS modules like CAPA, training, and document control
- Robust compliance tools with configurable templates for global standards
Cons
- Steep learning curve for complex configurations
- High implementation and customization costs
- Interface feels dated compared to modern SaaS tools
Best For
Mid-to-large regulated organizations in pharma, biotech, and medical devices requiring end-to-end audit management within a validated QMS.
Pricing
Quote-based enterprise pricing; typically $50,000+ annually for base audit module, scaling with users, modules, and validation services.
ETQ Reliance
enterpriseDelivers flexible enterprise quality management software with robust audit management, risk assessment, and real-time analytics.
No-code configuration engine allowing business users to build and modify audit workflows without IT involvement
ETQ Reliance is a robust, cloud-based enterprise quality management system (QMS) designed to streamline audit processes, including planning, execution, reporting, and follow-up actions. It excels in risk-based auditing, supplier assessments, and compliance management for regulated industries like manufacturing, life sciences, and aerospace. The platform integrates seamlessly with other quality modules such as CAPA, complaints, and document control for a holistic approach to quality assurance.
Pros
- Highly configurable no-code workflows for custom audit processes
- Comprehensive audit analytics and risk-based prioritization tools
- Strong integration capabilities with ERP, MES, and other enterprise systems
Cons
- Steep learning curve for initial setup and configuration
- Premium pricing suitable mainly for mid-to-large enterprises
- Implementation can take several months for complex deployments
Best For
Large enterprises in regulated industries requiring scalable, highly customizable audit management within a full QMS suite.
Pricing
Custom enterprise pricing, typically starting at $50,000+ annually based on users, modules, and deployment scale; quotes required.
Qualio
specializedOffers a modern eQMS platform designed for quality audits, document control, and compliance in life sciences.
No-code configurable audit workflows that integrate seamlessly with document control and CAPA for end-to-end quality traceability
Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences companies, with robust tools for managing audits alongside documents, training, CAPA, and supplier quality. Its audit module supports planning, scheduling, execution, evidence collection, and reporting, all while maintaining full traceability and compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. Qualio streamlines quality audits by integrating them into a unified platform, reducing silos and enabling real-time collaboration.
Pros
- Intuitive, no-code interface for quick audit setup and execution
- Strong regulatory compliance with automated audit trails and e-signatures
- Integrated eQMS reduces need for multiple tools
Cons
- Higher pricing may deter small startups
- Limited advanced analytics in audit reporting
- Fewer native integrations than enterprise competitors
Best For
Mid-sized life sciences companies needing a compliant, user-friendly platform for end-to-end audit management within a full QMS.
Pricing
Custom quote-based pricing, typically starting at $1,000–$2,000/month for small teams (10–50 users), scaling with company size and modules.
AuditBoard
enterpriseStreamlines audit, risk, and compliance processes with connected risk management and SOX compliance tools.
Connected Risk framework that unifies audits, risks, controls, and issues across the organization in a single platform
AuditBoard is a cloud-based governance, risk, and compliance (GRC) platform that streamlines audit management, risk assessment, and regulatory compliance processes. It supports the full audit lifecycle from planning and fieldwork to reporting and analytics, with customizable workflows suitable for internal and operational audits including quality audits. The tool is particularly strong in SOX compliance and enterprise risk management, helping organizations track controls, issues, and remediation in regulated environments.
Pros
- Comprehensive end-to-end audit lifecycle management
- Powerful analytics and real-time dashboards
- Strong integrations with ERP, HRIS, and other enterprise systems
Cons
- High cost prohibitive for small to mid-sized teams
- Steep learning curve for complex configurations
- Less specialized for pure quality management systems like ISO 9001
Best For
Mid-to-large enterprises in regulated industries needing integrated GRC and audit capabilities for compliance-heavy quality audits.
Pricing
Custom quote-based pricing; typically starts at $50,000+ annually for enterprise plans based on users and modules.
TeamMate+
enterpriseProvides end-to-end audit management software for planning, fieldwork, and reporting in internal audits.
Fully configurable audit methodologies and workflows that adapt to ISO quality standards and custom audit frameworks
TeamMate+ is a robust enterprise-grade audit management platform designed to handle the full audit lifecycle, from planning and scoping to fieldwork, reporting, and follow-up. It excels in supporting internal audits, risk assessments, compliance checks, and quality auditing processes through customizable workflows, evidence storage, and analytics. Primarily targeted at large organizations, it integrates with data analytics tools to provide actionable insights for quality control and assurance.
Pros
- Comprehensive end-to-end audit lifecycle management
- Advanced analytics and customizable reporting dashboards
- Strong collaboration tools for distributed audit teams
Cons
- Steep learning curve for new users
- High implementation and licensing costs
- Limited out-of-the-box simplicity for smaller audits
Best For
Large enterprises and audit teams managing complex, high-volume quality and compliance audits across multiple locations.
Pricing
Quote-based enterprise pricing, typically starting at $20,000+ annually for mid-sized deployments, scaling with users and modules.
Hyperproof
enterpriseAutomates compliance operations and audits with evidence collection, control mapping, and risk monitoring.
Automated evidence gathering and mapping across 50+ integrations for continuous audit readiness
Hyperproof is a compliance operations platform designed to automate evidence collection, continuous monitoring, and audit management for frameworks like SOC 2, ISO 27001, and quality standards such as ISO 9001. It centralizes control libraries, risk assessments, and remediation workflows to keep organizations audit-ready. While strong in GRC, it supports quality audits through customizable evidence mapping and reporting.
Pros
- Automated evidence collection from cloud integrations reduces manual work
- Comprehensive control libraries and real-time monitoring for ongoing compliance
- Strong collaboration tools for audit teams and stakeholders
Cons
- Enterprise-focused pricing may be prohibitive for smaller teams
- Steeper learning curve for non-compliance experts
- Less specialized for manufacturing-specific quality audits like CAPA or defect tracking
Best For
Mid-sized to large enterprises managing compliance-heavy quality audits across IT and operational frameworks.
Pricing
Custom enterprise pricing; typically starts at $20,000+ annually based on users and modules (contact sales for quote).
ComplianceQuest
enterpriseDelivers Salesforce-powered QMS for quality audits, CAPA, and supplier management.
Seamless Salesforce-native integration that unifies audit data with CRM, ERP, and other enterprise systems for holistic compliance visibility
ComplianceQuest is a comprehensive Quality Management System (QMS) built on the Salesforce platform, with robust audit management capabilities for planning, executing, and tracking internal, supplier, and customer audits. It streamlines audit workflows by integrating them seamlessly with CAPA, non-conformance, complaints, and supplier quality processes, ensuring end-to-end compliance. The platform provides real-time dashboards, automated notifications, and advanced reporting to drive continuous improvement in regulated industries like manufacturing, life sciences, and aerospace.
Pros
- Deep integration of audits with full QMS modules like CAPA and supplier management
- Customizable workflows and Salesforce scalability for enterprise needs
- Strong analytics, mobile access, and AI-driven insights for audit efficiency
Cons
- Steep learning curve due to Salesforce-based interface and customization requirements
- Enterprise pricing may be prohibitive for small to mid-sized organizations
- Overkill for companies needing standalone audit tools without broader QMS
Best For
Mid-to-large enterprises in highly regulated industries seeking an integrated QMS with advanced audit management.
Pricing
Quote-based enterprise pricing, typically starting at $75-$150 per user/month with minimum commitments, plus Salesforce licensing.
AssurX
enterpriseManages quality events, audits, and compliance with integrated workflow automation.
No-code configuration engine that allows non-technical users to fully customize audit workflows, forms, and processes without programming.
AssurX is a robust enterprise Quality Management System (QMS) platform that excels in audit management, compliance tracking, and risk mitigation for regulated industries like manufacturing, healthcare, and life sciences. It enables users to conduct audits, inspections, and assessments with configurable workflows, automated notifications, and real-time reporting to ensure regulatory adherence. The software integrates quality processes such as CAPA, complaints, and supplier management into a unified system, reducing silos and improving operational efficiency.
Pros
- Highly configurable no-code workflows for custom audit processes
- Strong integration with ERP and other enterprise systems
- Comprehensive reporting and analytics for audit insights
Cons
- Steep learning curve for initial setup and customization
- Pricing lacks transparency and is quote-based only
- Mobile app functionality is limited compared to desktop
Best For
Mid-to-large enterprises in highly regulated industries requiring a scalable, integrated QMS for complex audit and compliance needs.
Pricing
Custom enterprise pricing upon request, typically starting at $50-$100 per user/month depending on modules, users, and deployment (cloud or on-premise).
MetricStream
enterpriseOffers an integrated GRC platform with quality audit, risk, and policy management capabilities.
Unified GRC platform that embeds quality audits within a broader risk and compliance ecosystem for interconnected insights
MetricStream is an enterprise-grade Governance, Risk, and Compliance (GRC) platform with a dedicated Audit Management module that excels in quality audits by automating planning, fieldwork, reporting, and follow-up actions. It supports compliance with standards like ISO 9001, FDA regulations, and SOX through integrated risk assessment and issue tracking. The solution provides real-time dashboards and AI-driven insights to enhance audit efficiency and quality control across global operations.
Pros
- Comprehensive end-to-end audit lifecycle automation including quality-specific checklists and evidence management
- Seamless integration with risk, compliance, and policy modules for holistic GRC
- Advanced analytics and AI-powered risk prioritization for proactive quality improvements
Cons
- Steep learning curve and complex initial setup for non-enterprise users
- High implementation costs and long deployment timelines
- Overly robust for small to mid-sized organizations focused solely on quality audits
Best For
Large enterprises in regulated industries like manufacturing, pharma, and finance needing integrated GRC with advanced quality audit capabilities.
Pricing
Quote-based enterprise licensing; typically starts at $50,000+ annually depending on modules and users.
Archer IRM
enterpriseProvides a unified risk management platform supporting quality audits, assessments, and regulatory compliance.
Unified data model that connects quality audits with enterprise risk and compliance for holistic visibility.
Archer IRM is a comprehensive enterprise governance, risk, and compliance (GRC) platform that includes robust audit management capabilities specifically suited for quality audits. It supports the full audit lifecycle from planning and fieldwork to reporting and remediation, with customizable workflows and real-time dashboards. The software integrates quality audit processes with broader risk management, enabling organizations to maintain ISO 9001 compliance and drive continuous improvement.
Pros
- Highly customizable audit workflows and templates
- Advanced analytics and real-time reporting for audit insights
- Seamless integration across GRC functions including risk and compliance
Cons
- Steep learning curve due to enterprise complexity
- Lengthy and costly implementation process
- Pricing not ideal for small to mid-sized businesses
Best For
Large enterprises requiring an integrated GRC platform with enterprise-grade quality audit management.
Pricing
Custom enterprise subscription pricing; typically starts at $50,000+ annually depending on modules and users.
Conclusion
The reviewed quality audit software options, spanning comprehensive QMS platforms to industry-specific tools, highlight diverse strengths. MasterControl stands out as the top choice, offering advanced audit tracking, CAPA, and compliance tools for regulated sectors. ETQ Reliance and Qualio follow closely, with flexible enterprise features and life sciences focus, respectively, each excelling in distinct areas.
To optimize your quality management processes, start with MasterControl—the top-ranked tool—for its robust capabilities in audit management and compliance support.
Tools Reviewed
All tools were independently evaluated for this comparison
