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Qualio vs MasterControl Quality Excellence Comparison (2026)

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Qualio logo

Qualio

MasterControl Quality Excellence logo

MasterControl Quality Excellence

Overview

Achieve 100% FDA/ISO/GxP compliance. 5x faster Document Control, Training, CAPA, NCRs, Audits and more. 2x faster accreditation.

Software to meet FDA, EMA, and ISO requirements, including quality event management (CAPA), document control, training, and more.

  • Platforms supported
  • Web-based
  • iPhone app
  • Android app
  • Windows Phone app
  • Typical customers
  • Freelancers
  • Small businesses
  • Mid size businesses
  • Large enterprises
  • Customer support
  • Phone
  • Online
  • Knowledge base
  • Video tutorials
  • Platforms supported
  • Web-based
  • iPhone app
  • Android app
  • Windows Phone app
  • Typical customers
  • Freelancers
  • Small businesses
  • Mid size businesses
  • Large enterprises
  • Customer support
  • Phone
  • Online
  • Knowledge base
  • Video tutorials

Video & Screenshots

Pricing

Starting from

Empty state illustration for "No pricing info"

No pricing info

  • Free trial available
  • Credit cardless trial
  • Free account
  • Subscription based

Starting from

12000

/user

  • Free trial available
  • Credit cardless trial
  • Free account
  • Subscription based

User reviews

4.6

138

5

4

3

2

1

89

38

9

2

0

  • Value for money
  • Ease of use
  • Features
  • Customer support
77%
would recommend this app

4.5

580

5

4

3

2

1

313

227

38

2

0

  • Value for money
  • Ease of use
  • Features
  • Customer support
68%
would recommend this app

Pros

“Security is another great feature, since you can adjust access depending on the user and apply watermarks across all documents.”
RV

Raymond V.

Cell and Gene Therapy Specialist

“Working in biopharmaceuticals has been a rewarding experience, requiring a strong focus on quality, compliance, and collaboration to ensure patient safety and product integrity.”
Verified reviewer profile picture

Genesis B.

Aseptic Technician

“One area where Qualio could improve is its overall flexibility, as some workflows can feel restrictive when trying to accommodate unique business processes.”
Verified reviewer profile picture

Genesis B.

Aseptic Technician

Pros

“It is a reliable and mature solution for managing quality systems in regulated environments and it supports digital transformation initiatives effectively. While there are areas that could be improved in terms of usability and flexibility, the platform provides strong compliance support and helps standardize quality processes across different functions and sites.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

“MasterControl Quality Excellence is a solid and comprehensive eQMS platform, particularly suitable for highly regulated industries such as pharmaceuticals and medical devices.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

“The supplier module has also been great for us so that we are able to keep track of our approved suppliers and which products they supply to us.”
KB

Karina B.

Manager, QMS system

Cons

“Collaboration was difficult because, until the collaborator feature was added, only the author and QA could see initiated/draft documents, which made for many accidental duplicates.”
AW

Abby W.

Quality Assurance Specialist

“Search limitations can feel clunky when looking for specific data.”
Verified reviewer profile picture

Loralie B.

Clinical Operations Consultant

“There is nothing I can point to that I did not like, other than I think the cloud storage could be larger”
Verified reviewer profile picture

Patricia M.

Administrative Director

Cons

“Some of the pain points are the cost of licensing, not having the ability for multiple collaborators to edit the same document simultaneously, and search functionality being tough for users who aren't as familiar with document numbers/names.”
JA

Johana A.

Jr MasterControl Sys Admin

“The performance on "on prem" version, pdf publishing time and constant issues with pdf not beeing generated, issues with custom forms created by MC.”
MM

Michal M.

IT QMS Software Administrator

“Additionally, controlled printing is a little bit of a hassle and is less flexible than the rest of Qx.”
AK

Aubrey K.

QC Project Support Specialist

  • Vendor responds to reviews
  • Last review2 months ago
  • Vendor responds to reviews
  • Last review13 days ago

Key features

  • Total features93
  • API
  • Access Controls/Permissions
  • Access Expiration Management
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Approval Workflow
  • Archiving & Retention
  • Assessment Management
  • Audit Management
  • Audit Performance
  • Audit Planning
  • Audit Trail
  • Automated Scheduling
  • Bills of Material
  • Business Process Control
  • Calibration Management
  • Change Management
  • Change Planning
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management
  • Compliance
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Content Management
  • Corrective and Preventive Actions (CAPA)
  • Course Management
  • Cross-system Integration
  • Customer Complaint Tracking
  • Customizable Branding
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard
  • Data Import/Export
  • Data Visualization
  • Defect Tracking
  • Design Management
  • Digital Signature
  • Document Automation
  • Document Capture
  • Document Check-in/Check-out
  • Document Classification
  • Document Coding & Control
  • Document Control
  • Document Generation
  • Document Lifecycle Management
  • Document Management
  • Document Review
  • Document Storage
  • Document Templates
  • Drag & Drop
  • EDI
  • Electronic Signature
  • Email Alerts
  • Environmental Compliance
  • Equipment Management
  • Execution
  • FDA Compliance
  • File Management
  • File Sharing
  • For Engineering Documents
  • Forms Management
  • Full Text Search
  • Generative AI
  • Governance
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • Incident Management
  • Inspection Management
  • Internal Controls Management
  • Inventory Management
  • Issue Management
  • Issue Tracking
  • MES
  • Machine and equipment
  • Maintenance
  • Maintenance Management
  • Maintenance Scheduling
  • Manufacturing Software
  • Mobile Access
  • Monitoring
  • Multi-Location
  • Multiple Format Support
  • Nonconformance Tracking
  • Operational Risk Management
  • Order Management
  • Performance Analysis
  • Policy Management
  • Predictive Analytics
  • Prioritization
  • Product Data Management
  • Production Scheduling
  • Project Management
  • Quality Assurance
  • Quality Control
  • Quality Management
  • Real-Time Analytics
  • Real-Time Data
  • Real-Time Notifications
  • Real-Time Reporting
  • Real-Time Updates
  • Reminders
  • Reporting & Statistics
  • Reporting/Analytics
  • Response Management
  • Revision History
  • Risk Alerts
  • Risk Analysis
  • Risk Assessment
  • Risk Management
  • Risk Methodology
  • Risk Reporting
  • Risk Scoring
  • Role-Based Permissions
  • Root Cause Analysis
  • Routing
  • Rules-Based Workflow
  • Safety Management
  • Scheduling
  • Search/Filter
  • Secure Data Storage
  • Single Sign On
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Tagging
  • Task Management
  • Third-Party Integrations
  • Traceability
  • Training Administration
  • Training Management
  • Trend Analysis
  • User Management
  • Version Comparison
  • Version Control
  • Version Rollback
  • Workflow Management
  • Total features132
  • API
  • Access Controls/Permissions
  • Access Expiration Management
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Approval Workflow
  • Archiving & Retention
  • Assessment Management
  • Audit Management
  • Audit Performance
  • Audit Planning
  • Audit Trail
  • Automated Scheduling
  • Bills of Material
  • Business Process Control
  • Calibration Management
  • Change Management
  • Change Planning
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management
  • Compliance
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Content Management
  • Corrective and Preventive Actions (CAPA)
  • Course Management
  • Cross-system Integration
  • Customer Complaint Tracking
  • Customizable Branding
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard
  • Data Import/Export
  • Data Visualization
  • Defect Tracking
  • Design Management
  • Digital Signature
  • Document Automation
  • Document Capture
  • Document Check-in/Check-out
  • Document Classification
  • Document Coding & Control
  • Document Control
  • Document Generation
  • Document Lifecycle Management
  • Document Management
  • Document Review
  • Document Storage
  • Document Templates
  • Drag & Drop
  • EDI
  • Electronic Signature
  • Email Alerts
  • Environmental Compliance
  • Equipment Management
  • Execution
  • FDA Compliance
  • File Management
  • File Sharing
  • For Engineering Documents
  • Forms Management
  • Full Text Search
  • Generative AI
  • Governance
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • Incident Management
  • Inspection Management
  • Internal Controls Management
  • Inventory Management
  • Issue Management
  • Issue Tracking
  • MES
  • Machine and equipment
  • Maintenance
  • Maintenance Management
  • Maintenance Scheduling
  • Manufacturing Software
  • Mobile Access
  • Monitoring
  • Multi-Location
  • Multiple Format Support
  • Nonconformance Tracking
  • Operational Risk Management
  • Order Management
  • Performance Analysis
  • Policy Management
  • Predictive Analytics
  • Prioritization
  • Product Data Management
  • Production Scheduling
  • Project Management
  • Quality Assurance
  • Quality Control
  • Quality Management
  • Real-Time Analytics
  • Real-Time Data
  • Real-Time Notifications
  • Real-Time Reporting
  • Real-Time Updates
  • Reminders
  • Reporting & Statistics
  • Reporting/Analytics
  • Response Management
  • Revision History
  • Risk Alerts
  • Risk Analysis
  • Risk Assessment
  • Risk Management
  • Risk Methodology
  • Risk Reporting
  • Risk Scoring
  • Role-Based Permissions
  • Root Cause Analysis
  • Routing
  • Rules-Based Workflow
  • Safety Management
  • Scheduling
  • Search/Filter
  • Secure Data Storage
  • Single Sign On
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Tagging
  • Task Management
  • Third-Party Integrations
  • Traceability
  • Training Administration
  • Training Management
  • Trend Analysis
  • User Management
  • Version Comparison
  • Version Control
  • Version Rollback
  • Workflow Management

Integrations

  • Total integrations21
  • ADP Workforce Now
  • Arena
  • Asana
  • Azure DevOps
  • Box
  • ComplianceWire
  • Confluence
  • GitHub
  • GitLab
  • Google Workspace
  • HubSpot CRM
  • HubSpot Service Hub
  • Jira
  • Microsoft 365
  • Microsoft Entra ID
  • Microsoft SQL Server
  • NetSuite
  • Okta
  • OneDrive
  • SAP BTP
  • Salesforce Sales Cloud
  • ServiceNow
  • Slack
  • Snowflake
  • Tableau
  • TestRail
  • UKG Pro
  • Workday HCM
  • Xray
  • Zendesk Suite
  • Zephyr Scale
  • Total integrations12
  • ADP Workforce Now
  • Arena
  • Asana
  • Azure DevOps
  • Box
  • ComplianceWire
  • Confluence
  • GitHub
  • GitLab
  • Google Workspace
  • HubSpot CRM
  • HubSpot Service Hub
  • Jira
  • Microsoft 365
  • Microsoft Entra ID
  • Microsoft SQL Server
  • NetSuite
  • Okta
  • OneDrive
  • SAP BTP
  • Salesforce Sales Cloud
  • ServiceNow
  • Slack
  • Snowflake
  • Tableau
  • TestRail
  • UKG Pro
  • Workday HCM
  • Xray
  • Zendesk Suite
  • Zephyr Scale