Qualio vs MasterControl Quality Excellence

KAWAK

Dot Compliance

MasterControl Quality Excellence

MasterControl is a quality management software (QMS) solution widely used in the life sciences industry, supporting compliance and efficiency for companies of all sizes. The platform provides integrated tools for managing audits, training, documents, and quality events, enhanced by data analytics and artificial intelligence (AI) capabilities. It is designed to help organizations streamline decision-making, accelerate product development, and maintain regulatory compliance.

kawak is a business management and document control solution that helps businesses manage audits, equipment, risks, human talent, and more from a centralized platform. It allows staff members to utilize the built-in customer service module to set up PQRS

Dot Compliance offers an AI-powered electronic Quality Management System (eQMS) built specifically for life sciences organizations. The Salesforce-native platform includes pre-validated quality processes covering document management, change control, CAPA, and risk management while maintaining compliance with industry standards including 21 CFR Part 11 and EU Annex 11. The system features Dottie, an AI assistant trained on compliance workflows to help organizations streamline operations.

Quality Assurance Specialist

There seems to be a lot of lack in the system actually being GMP compliant.

GM QA and RA

The second-best thing about Qualio is their support team.

Regulatory Affairs Representative

They are super responsive when it comes to new inquiries for product enhancements or general support questions.

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

Access Controls/Permissions

Activity Dashboard

Activity Tracking

Alerts/Escalation

Alerts/Notifications

Approval Process Control

Approval Workflow

Archiving & Retention

Assessment Management

Audit Management

Audit Planning

Audit Trail

Change Management

Change Planning

Collaboration Tools

Commenting/Notes

Communications Management

Complaint Management

Compliance Management

Compliance Tracking

Configurable Workflow

Content Management

Corrective and Preventive Actions (CAPA)

Course Management

Customizable Branding

Customizable Forms

Customizable Reports

Customizable Templates

Dashboard

Data Import/Export

Data Visualization

Defect Tracking

Document Automation

Document Capture

Document Coding & Control

Document Generation

Document Lifecycle Management

Document Management

Document Review

Document Storage

Document Templates

Drag & Drop

Electronic Signature

Email Alerts

Environmental Compliance

Equipment Management

FDA Compliance

File Management

File Sharing

Forms Management

Full Text Search

Governance

HIPAA Compliant

Incident Management

Inspection Management

ISO Compliance

ISO Standards Management

Issue Management

Maintenance Management

Monitoring

Nonconformance Tracking

Policy Management

Quality Control

Real-Time Analytics

Real-Time Data

Real-Time Notifications

Real-Time Reporting

Real-Time Updates

Reminders

Reporting & Statistics

Revision History

Risk Analysis

Risk Assessment

Risk Management

Role-Based Permissions

Root Cause Analysis

Rules-Based Workflow

Search/Filter

Secure Data Storage

Single Sign On

Status Tracking

Supplier Management

Supplier Quality Control

Tagging

Task Management

Third-Party Integrations

Training Administration

Training Management

Trend Analysis

User Management

Version Control

Workflow Management

By industry, Qualio reviewers are most commonly professionals in medical devices (36%). The most frequent use case for Qualio cited by reviewers is quality management (81% of reviewers).

Users and use cases

Qualio is a quality management solution offering key features such as document management, access controls/permissions, corrective and preventive actions (CAPA), and document storage, among others.

Open Source

Qualio

Web-based

QT9 QMS

Document Control

Foundation

Growth

Scale

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.

Administrative Director

I like that Qualio is secure and I can collaborate with my team to automate our workflow.

President

Qualio offers a unified and user-friendly platform to integrate our teams, tools, and data.

Resonance Health has faced a lot of issues when people with access to create drafts created drafts without prior permission and without any need of new document.

There is nothing I can point to that I did not like, other than I think the cloud storage could be larger

Manager of Islet Product Manufacturing

I have to constantly export the documents to ensure the worksheets I make aren't broken up between pages (I suggest some sort of preview of page alignment, so that I don't constantly have to DL a PDF when I'm formatting Worksheets).

Quality and Compliance Director

This experience also spills over to their events module allowing me to personalise an audit and risk functionality that fit the mould of my companies quality journey.  

The best thing about Qualio is that you can customise it according to you own operations.

Quality Assurance Manager

They are a team that strives to deliver a product that meets the needs of its clients and is continually improving upon past versions to deliver a product and experience that is unobtrusive to workflow at a reasonable cost.

QA Director

Almost endless configuration capabilities allowing the creation of documents and events that fit your QMS instead of rebuilding your QMS to fit the software.

support engineer

Moreover the way it keeps me abreast with my training needs is also something I appreciate the most.

QARA Engineer

The inability to revision control templates directly. If templates update, changes within sections have to be applied manually to documents in draft.

QA RA

I appreciate that all of the main functionalities (document management, CAPA, Complaint, Supplier Management, etc.) are available in the system.

ACRM

Training vedio can not be watched in the platform.2) CAPA creation is make by special users. When I use VeevaVault before, it can be created by any users.3) For almorst due training, I do not see the reminder letters.

Moreover retrieving the current processes are also easy

Qualio still have some sticking points with the document creation journey and while they are improving every day, they are still sorely lacking ease with the creation, reviewer and approval experience.  

Quality Manager

Most everything in Qualio requires the same effort as a manual system (document control/life cycle is the exception, although some software offers version control!)

Firmware Engineer

Cannot exit an attachment preview unless scrolling to the top of the window and pressing the X. That can be frustrating when viewing multiple page word or PDFs.

software engineer

Qualio does not keep resolved comments. When someone completes review and click ‘Mark as reviewed’ in Qualio, no email notification is received.

DDMS

I like that it send an out reminders every Monday and helps us keep tabs of days and deadlines.

Director of Quality

I needed to ensure that employees are comfortable using a system and focusing on creating documentation and other items and not worrying about how to use the software.

Biomanufacturing Lead

Some of the permissions assignment are a bit cumbersome and the change control is a bit longer than it needs to be for our company at this stage.

The 'compare against' function is not very useful as often it highlights entire sections of text instead of the specific changes.

Production Manager

Perhaps there could be a feature which allows for smart linking to a specific version vs. most current version.

Mems test engineer

This software is very useful regarding providing security and organizing all the documents which can be very helpful for a company.

I like the version control of documents and that minor changes can be made without sending the document for re-training.

Sr PD Engineer

The e-QMS feature and pairing with Adobe makes this a eco-friendly and high quality QMS

Senior Quality Manager

Categorizing tags in the drop-down Template- linking a template in documents.

Director Quality Assurance and Regulatory Affairs

Inability to lock values and text fields in Events and documents.  

Quality 

Qualio also helps us organize our training and events such as CAPA's and NCMR's.

Training specalist

The electric sign off to ensure staff are completing Qualio along with being able to add test.

It would be a perfect A if the word processor built into the program was a little more user friendly when it comes to formatting things like Worksheets.

Quality Representative

documents structure (hierarchy) not visible, impossible to copy events configuration from Sandbox into PROD

Sr. Director of Quality

Lastly, their design control module is really a requirements management tool and does not actually assist with design control.

Sometimes it shows large chunks of text as removed and replaced when only a few changes were made.

Sometimes for training the documents are shaped in a complicated way, when they can deliver the point much easier way.

Quality control manager

It could be better for each lauch train to have an independent industry centric webinar for trainings

The file organization and linking abilities from documents within documents is very good.

Quality Coordinator

The fact that I can not archive and retrieve expired supplier documents

Head of Regulatory & Quality Assurance

The change control element and the Training module was a huge bonus - especially when this was originally done manually all those years.  

I like that Qualio let you keep all your documentation and training in one place, organized and easy to change when its required.

Plant Manager

We easily pass cGMP complaince audits utilizing all features of Qualio.  

Project Manager

We can easily manage documents version in with version history.

I also appreciate that they are regularly improving the system and that there is good attention on providing supporting validation documentation.

Head of QA/RA

At our most recent audit,  the auditor commented how much better structured our technical files were now that we had switched to Qualio

Head of Regulatory

should provide more consukting when needed by client, also the cost to run the system forward is quite high

Stamping a form with the form number automatically instead of a manual addition.

Reviewers indicate that Qualio's document management capabilities make it easy to trace, retrieve, and update documents, with helpful reminders for periodic reviews. Users report that Qualio supports compliance with ISO and FDA standards by providing audit trails, version control, and linking related documents. They find document templates and sorting options valuable for efficiency. However, users mention weak control over draft creation and difficulties in tracking proposed changes, suggesting Qualio's document management could improve in these areas. Of the 19 Qualio users who gave detailed accounts of their use of Document Management, 100% rated this feature as important or highly important.

Qualio vs MasterControl Quality Excellence Comparison (2026)

Qualio

MasterControl Quality Excellence

Overview

Video & Screenshots

Pricing

User reviews

Key features

Integrations

Alternatives