Quick Overview
- 1#1: MasterControl - Delivers comprehensive QMS document control with automated workflows, version management, electronic signatures, and regulatory compliance features.
- 2#2: ETQ Reliance - Provides highly configurable document management for QMS, including approvals, audit trails, and integration with CAPA and training modules.
- 3#3: Veeva Vault - Offers cloud-based document lifecycle management tailored for life sciences with robust validation, versioning, and global compliance support.
- 4#4: ComplianceQuest - Salesforce-native QMS platform featuring intuitive document control, collaboration, and AI-driven search for quality processes.
- 5#5: Qualio - Streamlines eQMS document management for biotech with e-signatures, automated routing, and seamless integration for startups to enterprises.
- 6#6: Greenlight Guru - MedTech-focused QMS software excelling in design control documents, risk management, and FDA/ISO compliance tracking.
- 7#7: Intelex - Flexible EHSQ platform with powerful document control, revision control, and customizable workflows for quality management.
- 8#8: AssurX - Configurable QMS solution providing end-to-end document management, event tracking, and real-time collaboration across departments.
- 9#9: Arena (PTC) - Cloud PLM/QMS hybrid with strong document control for BOMs, change management, and supplier collaboration in manufacturing.
- 10#10: QT9 QMS - Cost-effective cloud QMS offering document storage, version history, approvals, and training matrix integration for small to mid-sized firms.
We evaluated these tools based on core features, reliability, user experience, and value, balancing power and practicality to suit organizations of varying scales and industry specializations.
Comparison Table
QMS document control software is essential for managing compliance, accuracy, and accessibility of critical documentation; this comparison table evaluates tools such as MasterControl, ETQ Reliance, Veeva Vault, ComplianceQuest, Qualio, and more, helping readers identify the best fit for their operational needs.
| # | Tool | Category | Overall | Features | Ease of Use | Value |
|---|---|---|---|---|---|---|
| 1 | MasterControl Delivers comprehensive QMS document control with automated workflows, version management, electronic signatures, and regulatory compliance features. | enterprise | 9.5/10 | 9.8/10 | 8.2/10 | 8.7/10 |
| 2 | ETQ Reliance Provides highly configurable document management for QMS, including approvals, audit trails, and integration with CAPA and training modules. | enterprise | 9.2/10 | 9.5/10 | 8.4/10 | 8.7/10 |
| 3 | Veeva Vault Offers cloud-based document lifecycle management tailored for life sciences with robust validation, versioning, and global compliance support. | enterprise | 8.7/10 | 9.3/10 | 7.9/10 | 8.2/10 |
| 4 | ComplianceQuest Salesforce-native QMS platform featuring intuitive document control, collaboration, and AI-driven search for quality processes. | enterprise | 8.4/10 | 9.1/10 | 7.6/10 | 8.0/10 |
| 5 | Qualio Streamlines eQMS document management for biotech with e-signatures, automated routing, and seamless integration for startups to enterprises. | specialized | 8.7/10 | 9.0/10 | 9.2/10 | 8.2/10 |
| 6 | Greenlight Guru MedTech-focused QMS software excelling in design control documents, risk management, and FDA/ISO compliance tracking. | specialized | 8.8/10 | 9.3/10 | 8.4/10 | 8.1/10 |
| 7 | Intelex Flexible EHSQ platform with powerful document control, revision control, and customizable workflows for quality management. | enterprise | 8.1/10 | 8.7/10 | 7.5/10 | 7.8/10 |
| 8 | AssurX Configurable QMS solution providing end-to-end document management, event tracking, and real-time collaboration across departments. | enterprise | 8.1/10 | 8.7/10 | 7.3/10 | 7.6/10 |
| 9 | Arena (PTC) Cloud PLM/QMS hybrid with strong document control for BOMs, change management, and supplier collaboration in manufacturing. | enterprise | 8.3/10 | 9.1/10 | 7.4/10 | 7.9/10 |
| 10 | QT9 QMS Cost-effective cloud QMS offering document storage, version history, approvals, and training matrix integration for small to mid-sized firms. | specialized | 8.0/10 | 8.5/10 | 7.8/10 | 7.5/10 |
Delivers comprehensive QMS document control with automated workflows, version management, electronic signatures, and regulatory compliance features.
Provides highly configurable document management for QMS, including approvals, audit trails, and integration with CAPA and training modules.
Offers cloud-based document lifecycle management tailored for life sciences with robust validation, versioning, and global compliance support.
Salesforce-native QMS platform featuring intuitive document control, collaboration, and AI-driven search for quality processes.
Streamlines eQMS document management for biotech with e-signatures, automated routing, and seamless integration for startups to enterprises.
MedTech-focused QMS software excelling in design control documents, risk management, and FDA/ISO compliance tracking.
Flexible EHSQ platform with powerful document control, revision control, and customizable workflows for quality management.
Configurable QMS solution providing end-to-end document management, event tracking, and real-time collaboration across departments.
Cloud PLM/QMS hybrid with strong document control for BOMs, change management, and supplier collaboration in manufacturing.
Cost-effective cloud QMS offering document storage, version history, approvals, and training matrix integration for small to mid-sized firms.
MasterControl
enterpriseDelivers comprehensive QMS document control with automated workflows, version management, electronic signatures, and regulatory compliance features.
Connected Process Intelligence, which uses AI to link documents to real-time manufacturing data and quality events for proactive compliance and continuous improvement.
MasterControl is a comprehensive QMS platform renowned for its document control capabilities, enabling secure management of the entire document lifecycle from creation and collaboration to approval, distribution, and obsolescence. It features advanced workflow automation, version control, electronic signatures, and full audit trails to ensure compliance with regulations like FDA 21 CFR Part 11, ISO 13485, and GxP standards. Designed for regulated industries, it integrates document control with CAPA, training, audits, and manufacturing processes for a unified quality ecosystem.
Pros
- Unmatched regulatory compliance and validation support with pre-validated modules
- Seamless automation of workflows and electronic approvals reducing manual errors
- Deep integration across QMS modules for end-to-end quality management
Cons
- Complex initial setup and implementation requiring significant time and expertise
- Premium pricing that may be prohibitive for small organizations
- Steeper learning curve for non-technical users
Best For
Enterprise-level organizations in life sciences, medical devices, and manufacturing needing robust, compliant document control integrated with broader QMS processes.
Pricing
Quote-based enterprise licensing; typically starts at $50,000+ annually depending on users, modules, and deployment scale, with subscription or perpetual options.
ETQ Reliance
enterpriseProvides highly configurable document management for QMS, including approvals, audit trails, and integration with CAPA and training modules.
No-code configuration platform enabling rapid, user-driven customization of document workflows without IT dependency
ETQ Reliance is a robust enterprise quality management system (eQMS) with powerful document control features, managing the full document lifecycle including creation, review, approval, distribution, and archiving. It offers automated workflows, version control, electronic signatures, and audit trails to ensure regulatory compliance in industries like manufacturing, life sciences, and aerospace. The platform integrates document control seamlessly with other QMS modules such as CAPA, audits, and training for a holistic quality approach.
Pros
- Highly configurable no-code workflows for document processes
- Strong compliance tools with e-signatures and audit trails
- Scalable integration across enterprise QMS functions
Cons
- Steep initial learning curve for complex configurations
- Custom quote-based pricing can be expensive for smaller teams
- Implementation may require consulting support
Best For
Mid-to-large enterprises in regulated industries needing integrated, compliant document control within a full eQMS.
Pricing
Custom enterprise pricing via quote; typically $50,000+ annually depending on users, modules, and deployment (cloud or on-premise).
Veeva Vault
enterpriseOffers cloud-based document lifecycle management tailored for life sciences with robust validation, versioning, and global compliance support.
Object-based data model enabling dynamic relationships between documents, metadata, and quality processes for superior lifecycle management
Veeva Vault is a cloud-based Quality Management System (QMS) platform tailored for life sciences industries, offering robust document control capabilities including secure storage, automated workflows, versioning, and electronic signatures. It ensures compliance with regulations like FDA 21 CFR Part 11 and EMA Annex 11 through features like audit trails, redlining, and lifecycle management. The platform supports collaborative authoring and integrates seamlessly with other Veeva applications for comprehensive quality processes.
Pros
- Exceptional regulatory compliance tools with built-in validation
- Scalable for global enterprises with strong integration capabilities
- Unified platform combining document control with CAPA, training, and audits
Cons
- Steep learning curve and complex configuration
- High cost prohibitive for small organizations
- Primarily optimized for life sciences, less flexible for non-regulated industries
Best For
Large pharmaceutical, biotech, and medical device companies requiring enterprise-grade compliant document management.
Pricing
Custom enterprise subscription pricing; typically starts at $100,000+ annually based on users and modules—contact sales for quote.
ComplianceQuest
enterpriseSalesforce-native QMS platform featuring intuitive document control, collaboration, and AI-driven search for quality processes.
Deep Salesforce integration linking document control directly to CRM and customer data for holistic quality processes
ComplianceQuest is a cloud-based Quality Management System (QMS) platform built on Salesforce, offering robust document control capabilities for regulated industries. It streamlines document lifecycle management with features like version control, automated workflows, electronic signatures, and advanced search functionality. The software ensures compliance with standards such as ISO 9001, FDA 21 CFR Part 11, and supports integration with other enterprise systems for seamless operations.
Pros
- Highly customizable workflows and automation via Salesforce low-code platform
- Strong regulatory compliance tools including audit trails and e-signatures
- Scalable for enterprise use with seamless CRM integration
Cons
- Steep learning curve due to Salesforce complexity
- Custom pricing can be expensive for small teams
- Implementation requires significant setup time and expertise
Best For
Mid-to-large enterprises in regulated sectors like manufacturing, life sciences, and automotive needing integrated QMS document control.
Pricing
Quote-based subscription starting around $50-100/user/month, depending on modules and scale; contact sales for details.
Qualio
specializedStreamlines eQMS document management for biotech with e-signatures, automated routing, and seamless integration for startups to enterprises.
Accelerated validation and go-live process, enabling teams to be compliant and operational in weeks rather than months
Qualio is a cloud-based eQMS platform tailored for life sciences companies, specializing in document control, version management, approvals, and training to ensure regulatory compliance. It provides electronic signatures, automated workflows, full audit trails, and real-time collaboration to replace spreadsheets and legacy systems. Ideal for agile teams, it supports FDA 21 CFR Part 11, ISO 13485, and other standards while integrating with tools like Google Workspace and Slack.
Pros
- Intuitive, modern interface with minimal training required
- Robust compliance tools including e-signatures and audit trails
- Fast setup and deployment, often live in weeks
Cons
- Pricing can be steep for very small teams
- Limited advanced customization for complex enterprise needs
- Integrations are good but not as extensive as some competitors
Best For
Growing life sciences startups and mid-sized companies needing a user-friendly, compliant document control solution without heavy IT overhead.
Pricing
Custom quote-based pricing starting around $1,200/month for small teams (up to 10 users); scales with users and features (Starter, Pro, Enterprise tiers).
Greenlight Guru
specializedMedTech-focused QMS software excelling in design control documents, risk management, and FDA/ISO compliance tracking.
Interconnected QMS ecosystem linking documents directly to risks, CAPAs, and change controls for medtech-specific compliance
Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform tailored for the medical device industry, with robust document control at its core. It enables secure version control, automated approval workflows, electronic signatures, and comprehensive audit trails to maintain compliance with FDA 21 CFR Part 820 and ISO 13485 standards. The software integrates document management seamlessly with other QMS modules like risk management, CAPA, and training, providing a unified platform for quality processes.
Pros
- Industry-specific compliance tools for medtech
- Integrated QMS modules beyond just documents
- Strong automation and audit trail capabilities
Cons
- High enterprise-level pricing
- Primarily suited for life sciences, less flexible elsewhere
- Initial setup and configuration can be time-intensive
Best For
Medical device companies needing a compliant eQMS with advanced document control integrated into full quality workflows.
Pricing
Custom quote-based pricing; typically starts at $5,000+ per month for mid-sized teams, scaling with users and modules.
Intelex
enterpriseFlexible EHSQ platform with powerful document control, revision control, and customizable workflows for quality management.
No-code configuration for building tailored document approval workflows integrated across EHSQ processes
Intelex is a comprehensive EHSQ (Environment, Health, Safety, and Quality) management platform with robust document control capabilities tailored for QMS needs. It provides centralized storage, version control, automated workflows for approvals and reviews, and ensures compliance with standards like ISO 9001. The software integrates seamlessly with other Intelex modules for audits, incidents, and training, making it ideal for holistic quality management.
Pros
- Comprehensive document lifecycle management with automated routing and electronic signatures
- Strong compliance and audit trail features for regulated industries
- Highly configurable no-code platform for custom workflows
Cons
- Steep learning curve due to extensive customization options
- Interface feels somewhat dated compared to modern SaaS tools
- Pricing is enterprise-focused and can be prohibitive for small teams
Best For
Mid-to-large enterprises in regulated sectors like manufacturing or pharma needing integrated EHSQ with advanced document control.
Pricing
Custom enterprise pricing via quote; typically SaaS subscriptions starting at $5,000+ per month based on users and modules.
AssurX
enterpriseConfigurable QMS solution providing end-to-end document management, event tracking, and real-time collaboration across departments.
Unified Quality Intelligence platform that automatically links documents to quality events, risks, and actions for proactive compliance
AssurX is an enterprise-grade Quality Management System (QMS) platform with robust document control capabilities tailored for regulated industries like life sciences and manufacturing. It manages the full document lifecycle, including authoring, review, approval workflows, version control, electronic signatures, and secure distribution while ensuring compliance with FDA 21 CFR Part 11, ISO 13485, and other standards. The software integrates document control with CAPA, audits, training, and complaints for a holistic quality ecosystem.
Pros
- Advanced compliance tools with e-signatures and audit trails
- Seamless integration across QMS modules like CAPA and audits
- Scalable for large enterprises with strong search and retrieval
Cons
- Steep learning curve and complex interface
- High implementation and customization costs
- Less intuitive for small teams or non-enterprise users
Best For
Large organizations in highly regulated industries such as pharmaceuticals, medical devices, and biotech needing integrated QMS document control.
Pricing
Custom enterprise pricing via quote; typically annual subscriptions starting at $50,000+ with implementation fees.
Arena (PTC)
enterpriseCloud PLM/QMS hybrid with strong document control for BOMs, change management, and supplier collaboration in manufacturing.
Integrated PLM-QMS platform with BOM-linked document control for end-to-end visibility in regulated product development
Arena by PTC is a cloud-based Quality Management System (QMS) and Product Lifecycle Management (PLM) platform specializing in document control for regulated industries like medical devices and aerospace. It offers secure document storage, automated revision control, workflow approvals, electronic signatures, and full audit trails to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and AS9100 standards. The software integrates document management with change control, CAPA, and supplier quality processes, enabling real-time collaboration across global teams.
Pros
- Comprehensive compliance tools with robust audit trails and e-signatures
- Seamless integration of QMS document control with PLM and BOM management
- Scalable cloud platform supporting global teams and real-time collaboration
Cons
- Steeper learning curve for non-enterprise users
- Custom enterprise pricing can be costly for smaller organizations
- Limited flexibility in UI customization compared to niche doc control tools
Best For
Mid-to-large manufacturers in highly regulated industries requiring integrated PLM-QMS document control.
Pricing
Quote-based enterprise pricing; typically starts at $5,000-$10,000/month for mid-sized deployments, scaling with users and modules.
QT9 QMS
specializedCost-effective cloud QMS offering document storage, version history, approvals, and training matrix integration for small to mid-sized firms.
Unlimited users and storage included, scaling effortlessly without per-user fees
QT9 QMS is a cloud-based Quality Management System software with robust document control features, enabling centralized storage, version control, automated approval workflows, and electronic signatures for compliance with ISO 9001, FDA, and other standards. It supports the full document lifecycle from creation to obsolescence, including training matrices and distribution lists. The platform integrates seamlessly with other QMS modules like CAPA, audits, and non-conformances for holistic quality management.
Pros
- Unlimited users at a flat subscription rate
- Strong compliance tools with full audit trails and e-signatures
- Integrated QMS modules reduce need for multiple tools
Cons
- Pricing can be high for very small teams
- Limited native integrations with non-QMS enterprise software
- Interface feels dated compared to modern SaaS tools
Best For
Mid-sized manufacturers in regulated industries needing integrated document control within a full QMS.
Pricing
Quote-based; starts at around $1,600/month for unlimited users, billed annually.
Conclusion
With a spectrum of top-tier solutions, MasterControl leads as the top choice, offering comprehensive QMS document control with automated workflows and regulatory support. ETQ Reliance follows closely, excelling in configurable processes and integration with critical modules, while Veeva Vault stands out for its tailored lifecycle management, ideal for life sciences needs. Each tool addresses unique requirements, but MasterControl’s holistic approach makes it a standout.
Don’t miss out—explore MasterControl to unlock its seamless, end-to-end document control features and elevate your quality management processes.
Tools Reviewed
All tools were independently evaluated for this comparison