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About

Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.

About

Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling

Platforms Supported

Windows Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Life science companies

Audience

Small and growing businesses in Life Sciences & Healthcare

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$25,000 / 1st year
25k for first year with a 5 license minimum
Free Version Not Supported
Free Trial Not Supported

Pricing

Qualio offers transparent, subscription-based pricing that scales with your users and needs. No hidden fees or per-module charges. Growth-stage companies benefit from fast time-to-value and significantly lower total cost of ownership than legacy platforms or consultant-heavy implementations. Contact us for a custom quote.n.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 4.5 / 5
ease 4.5 / 5
features 5.0 / 5
design 4.5 / 5
support 4.5 / 5

Reviews/Ratings

Pros & Cons from Real Users

Pros

  • Documents,training and quality all link up together. Has the ability to create custom web forms to meet the specific needs of the company. It enables business process workflow.
  • - The best feature is definitely the fact that this is a web based tool that stores everything in the cloud and has no system dependency.

Cons

  • Such function is good but simple searches can turn up too many unnecessary results.
  • The UI can definitely be further simplified to remove unnecessary buttons that might confuse the uninitiated. Currently, it's also a bit difficult to get help information from the UI.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Company Information

MasterControl
Founded: 1994
United States
www.mastercontrol.com

Company Information

Qualio
Founded: 2010
United States
www.qualio.com

Alternatives

Alternatives

Propel

Propel

Propel Software
Propel

Propel

Propel Software
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
CAQ.Net

CAQ.Net

CAQ AG Factory Systems
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Not Supported
Training Management Supported

Change Management Features

Approval Workflow Supported
Audit Trail Supported
Automated Notifications Not Supported
Change Calendar Not Supported
Change Planning Supported
Compliance Management Supported
Prioritization Not Supported
Release Management Supported
Task Management Supported
Tracking & Reporting Not Supported
Training Management Supported

Complaint Management Features

Case Management Not Supported
Complaint Classification Supported
Corrective Actions (CAPA) Supported
Customer Complaint Tracking Supported
Feedback Management Supported
Forms Management Supported
Issue Tracking Supported
Quality Assurance Management Supported
Routing Supported
Self Service Portal Not Supported
Social Media Monitoring Not Supported
Survey Management Not Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Not Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Supported
Email Management Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Supported
Full Text Search Supported
Offline Access Supported
Optical Character Recognition Supported
Print Management Supported
Version Control Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Supported
Audit Trail Supported
Commenting / Notes Supported
Document Check-in / Check-out Supported
For Engineering Documents Supported
Revision History Supported
Version Comparison Supported
Version Rollback Supported

Risk Management Features

Alerts/Notifications Supported
Auditing Supported
Business Process Control Supported
Compliance Management Supported
Corrective Actions (CAPA) Supported
Dashboard Supported
Exceptions Management Not Supported
Internal Controls Management Supported
IT Risk Management Not Supported
Legal Risk Management Not Supported
Mobile Access Supported
Operational Risk Management Supported
Predictive Analytics Supported
Reputation Risk Management Not Supported
Response Management Supported
Risk Assessment Supported

SPC Features

Corrective Actions (CAPA) Supported
Data Entry Not Supported
Data Linking Not Supported
Data Management Not Supported
Excel Loader Not Supported
Job Management Not Supported
OPC Data Collection Not Supported
Performance Metrics Not Supported
Point-of-Production Analysis Not Supported
Real Time Data Collection Not Supported
Regulatory Compliance Supported

Work Instructions Features

Branding & Style Sheets Not Supported
Content Management System Not Supported
Drag and Drop Not Supported
Dynamic Tags Not Supported
Employee Feedback Not Supported
Guide Approval Workflows Not Supported
Media Editor Not Supported
Multi-Brand Publishing Not Supported
Rich Text Editor Not Supported
SSO (SAML) Not Supported
Translations Not Supported
User Management Not Supported
Version Control Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Policy Management Features

Approval Process Control Supported
Attestation Supported
Audit Trails Supported
Policy Creation Supported
Policy Library Supported
Policy Metadata Management Supported
Policy Training Supported
Reporting / Analytics Supported
Version Control Supported
Workflow Management Supported

Integrations

Asana Not Supported
Auth0 Not Supported
Azure AI Anomaly Detector Not Supported
Azure DevOps Not Supported
Azure DevOps Labs Not Supported
Essenvia Not Supported
GitHub Advanced Security Not Supported
GitLab Not Supported
Google Cloud Operations Suite Not Supported
HubSpot CRM Not Supported
Intercom Not Supported
Microsoft 365 Not Supported
Microsoft OneDrive Not Supported
Microsoft PowerPoint Supported
Microsoft Word Supported
Okta Not Supported
SSOJet Not Supported
TestRail Not Supported
Xray Not Supported
Zendesk Not Supported

Integrations

Asana Supported
Auth0 Supported
Azure AI Anomaly Detector Supported
Azure DevOps Supported
Azure DevOps Labs Supported
Essenvia Supported
GitHub Advanced Security Supported
GitLab Supported
Google Cloud Operations Suite Supported
HubSpot CRM Supported
Intercom Supported
Microsoft 365 Supported
Microsoft OneDrive Supported
Microsoft PowerPoint Not Supported
Microsoft Word Not Supported
Okta Supported
SSOJet Supported
TestRail Supported
Xray Supported
Zendesk Supported
Claim MasterControl and update features and information
Claim MasterControl and update features and information