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MasterControl Quality Excellence vs Risk Hawk Comparison (2026)

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Good recommendations?

MasterControl Quality Excellence logo

MasterControl Quality Excellence

Risk Hawk logo

Risk Hawk

Overview

MasterControl Qx, the #1 QMS for life sciences, simplifies FDA, EMA, and ISO compliance, and speeds quality products to market.

Integrated Risk Management system to actively manage all risks & KRIs, controls, incidents, policies, audits, action plans, resources, compliance registers, case queues such as whistleblowing, complaints, SARs, media reports, and regulatory notifications and facilitates linking these to each other.

  • 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

No videos yet

Pricing

Starting from

12000

/user

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

Starting from

Empty state illustration for "No pricing info"

No pricing info

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

User reviews

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

4.8

56

5

4

3

2

1

47

7

2

0

0

  • Value for money
  • Ease of use
  • Features
  • Customer support
93%
would recommend this app

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

“Some modules could benefit from a more modern and user-friendly interface, and system performance may occasionally slow down when handling large processes or extensive datasets.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

Pros

“An effective and user-friendly audit tool that helps streamline audit procedures, documentation, and review.”
Verified reviewer profile picture

Midhun k.

Partner

“Some things that larger clients expect are not yet in place, like proper version control between test and live environments or automated event triggers for integrations.”
UT

Utkarsh T.

Program Manager

“Risk management, controls, audits, incidents, and compliance are all connected, which makes life much easier for small and mid-sized teams.”
UT

Utkarsh T.

Program Manager

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

“With the cloud and licensing model changes, we've seen a dramatic increase in licensing fees, while simultaneously losing the ability to implement custom solutions and assign user rights freely.”
Verified reviewer profile picture

Jeremy R.

Sr. Manager, SQA

Cons

“At times, system performance may feel slow while uploading data or generating reports.”
NM

Niranjan M.

Deputy Manager

“Navigation between some screens takes more clicks than it should.”
UT

Utkarsh T.

Program Manager

“It has already curtailed down our manual work.”
SN

Setu N.

Risk Manager

  • Vendor responds to reviews
  • Last review9 days ago
  • Vendor responds to reviews
  • Last review16 days ago

Key features

  • Total features132
  • AI Summarization
  • AI Text Generation
  • AI Text Summarization
  • AI/Machine Learning
  • API
  • Access Controls/Permissions
  • Access Expiration Management
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Assessment Management
  • Asset Tracking
  • Attestation
  • Audit Management
  • Audit Performance
  • Audit Planning
  • Audit Trail
  • Automated Scheduling
  • Bills of Material
  • Business Process Automation
  • Business Process Control
  • Calendar Management
  • Calibration Management
  • Change Management
  • Checklists
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management
  • Compliance
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Configuration Management
  • Content Management
  • Contract/License Management
  • Corrective and Preventive Actions (CAPA)
  • Cost Tracking
  • Cross-system Integration
  • Customer Complaint Tracking
  • Customizable Branding
  • Customizable Fields
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard
  • Dashboard Creation
  • Data Import/Export
  • Data Visualization
  • Decision Making
  • Defect Tracking
  • Design Management
  • Digital Signature
  • Disaster Recovery
  • Document Analysis
  • Document Approval
  • 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
  • EDI
  • Electronic Signature
  • Email Alerts
  • Email Management
  • Enterprise Risk Management
  • Environmental Compliance
  • Equipment Management
  • Event Logs
  • Evidence Management
  • Exceptions Management
  • Execution
  • FDA Compliance
  • File Management
  • File Sharing
  • For Engineering Documents
  • Forms Automation
  • Forms Management
  • Full Text Search
  • Generative AI
  • Governance
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • IT Incident Management
  • IT Risk Management
  • Incident Management
  • Incident Reporting
  • Inspection Management
  • Internal Controls Management
  • Inventory Management
  • Investigation Management
  • Issue Management
  • Issue Tracking
  • KRI (Key Risk Indicator) Monitoring
  • Legal Risk Management
  • Lifecycle Management
  • MES
  • Machine and equipment
  • Maintenance
  • Maintenance Management
  • Maintenance Scheduling
  • Manufacturing Software
  • Mobile Access
  • Mobile Alerts
  • Monitoring
  • Multi-Channel Communication
  • Multi-Location
  • Multiple Format Support
  • Natural Language Interaction
  • No-Code
  • Nonconformance Tracking
  • On Call Scheduling
  • Operational Risk Management
  • Order Management
  • Performance Analysis
  • Performance Metrics
  • Policy Creation
  • Policy Library
  • Policy Management
  • Policy Metadata Management
  • Policy Training
  • Predictive Analytics
  • Prioritization
  • Problem Management
  • Process Change Tracking
  • Process Modeling & Designing
  • Process Overview
  • Process Repository
  • Procurement Management
  • Product Data Management
  • Production Scheduling
  • Project Management
  • Quality Assurance
  • Quality Control
  • Quality Management
  • Real-Time Analytics
  • Real-Time Data
  • Real-Time Monitoring
  • Real-Time Notifications
  • Real-Time Reporting
  • Real-Time Updates
  • Reminders
  • Reporting & Statistics
  • Reporting/Analytics
  • Reports
  • Reputational Risk Management
  • Requisition Management
  • 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 Incident Management
  • Safety Management
  • Sarbanes-Oxley Compliance
  • Scheduling
  • Search/Filter
  • Secure Data Storage
  • Security Auditing
  • Self Service Portal
  • Service Level Agreement (SLA) Management
  • Single Sign On
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Support Ticket Management
  • Surveys & Feedback
  • Task Management
  • Task Progress Tracking
  • Template Management
  • Templates
  • Third-Party Integrations
  • Traceability
  • Training Management
  • Trend Analysis
  • User Management
  • Vendor Management
  • Version Comparison
  • Version Control
  • Version Rollback
  • Vulnerability Assessment
  • Workflow Management
  • Total features147
  • AI Summarization
  • AI Text Generation
  • AI Text Summarization
  • AI/Machine Learning
  • API
  • Access Controls/Permissions
  • Access Expiration Management
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Assessment Management
  • Asset Tracking
  • Attestation
  • Audit Management
  • Audit Performance
  • Audit Planning
  • Audit Trail
  • Automated Scheduling
  • Bills of Material
  • Business Process Automation
  • Business Process Control
  • Calendar Management
  • Calibration Management
  • Change Management
  • Checklists
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management
  • Compliance
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Configuration Management
  • Content Management
  • Contract/License Management
  • Corrective and Preventive Actions (CAPA)
  • Cost Tracking
  • Cross-system Integration
  • Customer Complaint Tracking
  • Customizable Branding
  • Customizable Fields
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard
  • Dashboard Creation
  • Data Import/Export
  • Data Visualization
  • Decision Making
  • Defect Tracking
  • Design Management
  • Digital Signature
  • Disaster Recovery
  • Document Analysis
  • Document Approval
  • 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
  • EDI
  • Electronic Signature
  • Email Alerts
  • Email Management
  • Enterprise Risk Management
  • Environmental Compliance
  • Equipment Management
  • Event Logs
  • Evidence Management
  • Exceptions Management
  • Execution
  • FDA Compliance
  • File Management
  • File Sharing
  • For Engineering Documents
  • Forms Automation
  • Forms Management
  • Full Text Search
  • Generative AI
  • Governance
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • IT Incident Management
  • IT Risk Management
  • Incident Management
  • Incident Reporting
  • Inspection Management
  • Internal Controls Management
  • Inventory Management
  • Investigation Management
  • Issue Management
  • Issue Tracking
  • KRI (Key Risk Indicator) Monitoring
  • Legal Risk Management
  • Lifecycle Management
  • MES
  • Machine and equipment
  • Maintenance
  • Maintenance Management
  • Maintenance Scheduling
  • Manufacturing Software
  • Mobile Access
  • Mobile Alerts
  • Monitoring
  • Multi-Channel Communication
  • Multi-Location
  • Multiple Format Support
  • Natural Language Interaction
  • No-Code
  • Nonconformance Tracking
  • On Call Scheduling
  • Operational Risk Management
  • Order Management
  • Performance Analysis
  • Performance Metrics
  • Policy Creation
  • Policy Library
  • Policy Management
  • Policy Metadata Management
  • Policy Training
  • Predictive Analytics
  • Prioritization
  • Problem Management
  • Process Change Tracking
  • Process Modeling & Designing
  • Process Overview
  • Process Repository
  • Procurement Management
  • Product Data Management
  • Production Scheduling
  • Project Management
  • Quality Assurance
  • Quality Control
  • Quality Management
  • Real-Time Analytics
  • Real-Time Data
  • Real-Time Monitoring
  • Real-Time Notifications
  • Real-Time Reporting
  • Real-Time Updates
  • Reminders
  • Reporting & Statistics
  • Reporting/Analytics
  • Reports
  • Reputational Risk Management
  • Requisition Management
  • 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 Incident Management
  • Safety Management
  • Sarbanes-Oxley Compliance
  • Scheduling
  • Search/Filter
  • Secure Data Storage
  • Security Auditing
  • Self Service Portal
  • Service Level Agreement (SLA) Management
  • Single Sign On
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Support Ticket Management
  • Surveys & Feedback
  • Task Management
  • Task Progress Tracking
  • Template Management
  • Templates
  • Third-Party Integrations
  • Traceability
  • Training Management
  • Trend Analysis
  • User Management
  • Vendor Management
  • Version Comparison
  • Version Control
  • Version Rollback
  • Vulnerability Assessment
  • Workflow Management

Integrations

  • Total integrations12
  • ADP Workforce Now
  • Arena
  • ChatGPT
  • ClassMarker
  • ComplianceWire
  • Gmail
  • Google Authenticator
  • Google Calendar
  • Microsoft 365
  • Microsoft Outlook
  • Microsoft Power Apps
  • Microsoft Power Automate
  • Microsoft Power BI
  • Microsoft SQL Server
  • MySQL
  • NetSuite
  • OAuth Platform
  • Oracle Database
  • Oracle E-Business Suite
  • SAP BTP
  • ServiceNow
  • Snowflake
  • Tableau
  • UKG Pro
  • Workday HCM
  • Total integrations15
  • ADP Workforce Now
  • Arena
  • ChatGPT
  • ClassMarker
  • ComplianceWire
  • Gmail
  • Google Authenticator
  • Google Calendar
  • Microsoft 365
  • Microsoft Outlook
  • Microsoft Power Apps
  • Microsoft Power Automate
  • Microsoft Power BI
  • Microsoft SQL Server
  • MySQL
  • NetSuite
  • OAuth Platform
  • Oracle Database
  • Oracle E-Business Suite
  • SAP BTP
  • ServiceNow
  • Snowflake
  • Tableau
  • UKG Pro
  • Workday HCM