Qualio

4.6 (124)
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Life science quality software for start-ups and scale-ups

About Qualio

Qualio is a cloud-based quality management software system designed for growing life science start-ups and scale-ups.

Qualio empowers medical device, pharmaceutical, biotech and contract organizations to get to market faster, boost revenue and cut risk. Over 650 companies in 80 countries trust Qualio to embed and automate unshakeable compliance with the demands of GxP, the FDA, ISO standards and more. Qualio unites your teams, processes and data in a single source of truth that supports a culture of quality and makes your business stronger, fitter and more competitive.

Pricing starting from:

US$0.00

  • Free Version
  • Free Trial
  • Subscription

Key benefits of Qualio

- Built for medical device, pharmaceutical, biotech and contract research/manufacturing organizations

- Designed for start-ups and scale-ups who need to optimize their quality maturity

- Manage quality documentation, training, CAPAs, deviations, change control, suppliers, medical device design controls and more

- Voted the #1 easiest eQMS to set up and use

- The only eQMS with in-app document editing for total control of your document lifecycle

- Connect your entire business to a single source of quality trust backed by powerful analytics and full audit traceability

- Stay compliant with real-time and detailed insights into documents, people and actions. Monitor content sent for review, approval and training. Track change controls in progress and completed training.

- Create your own templates for documents, forms and records - or access pre-built industry-ready Qualio+ templates for accelerated compliance

- Used by over 650 companies to comply with:
- ISO 9001
- ISO 13485
- ISO 14971
- GxP, from GCP to cGMP and GDocP
- The EU MDR/IVDR
- UK Medical Devices Regulations
- ICH Qx guidelines

And more!

Typical Customers

  • Freelancers
  • Small Businesses (2-50)
  • Mid-size Companies (51-500)
  • Large enterprises (500 and more)

Deployment

  • Cloud-based
  • On-premise

Markets

Australia, Austria, Belgium, Canada, Denmark and 19 others

Supported Languages

English

Pricing starting from:

US$0.00

  • Free Version
  • Free Trial
  • Subscription

Images

Qualio Software - Automate document and record control
Qualio Software - Effortlessly capture training progress
Qualio Software - Track any kind of quality event to completion
Qualio Software - Configure and manage suppliers with ease
Qualio Software - See and track your entire quality landscape
Qualio Software - Control all your medical device's design elements
Qualio Software - All your change control reports in one place
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Qualio Software - Automate document and record control
Qualio Software - Effortlessly capture training progress
Qualio Software - Track any kind of quality event to completion
Qualio Software - Configure and manage suppliers with ease
Qualio Software - See and track your entire quality landscape
Qualio Software - Control all your medical device's design elements
Qualio Software - All your change control reports in one place

Features

Total features of Qualio: 92

  • API
  • 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 Software
  • Change Planning
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Content Management System (CMS) Software
  • Corrective and Preventive Actions (CAPA)
  • Course Management
  • Customizable Branding
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard Software
  • Data Import/Export
  • Data Visualization Software
  • Defect Tracking
  • Document Automation
  • Document Capture
  • Document Coding & Control
  • Document Generation Software
  • Document Lifecycle Management
  • Document Management Software
  • Document Review
  • Document Storage
  • Document Templates
  • Drag & Drop
  • Electronic Signature
  • Email Alerts
  • Environmental Compliance
  • Equipment Management
  • FDA Compliance
  • File Management
  • Forms Management
  • Full Text Search
  • Governance
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • Incident Management Software
  • Inspection Management
  • Issue Management
  • Maintenance Management Software
  • Monitoring
  • Nonconformance Tracking
  • Policy Management Software
  • 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 Software
  • Role-Based Permissions
  • Root Cause Analysis
  • Rules-Based Workflow
  • Search/Filter
  • Secure Data Storage
  • Single Sign On Software
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Tagging
  • Task Management Software
  • Third-Party Integrations
  • Training Administration
  • Training Management
  • Trend Analysis
  • User Management
  • Version Control
  • Workflow Management Software

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Document Control

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Greenlight Guru

4.4
#3 Alternative to Qualio
Greenlight Guru helps medical device businesses create, launch, and manage custom workflow templates to streamline...

Gavel

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#4 Alternative to Qualio
Gavel is legal document automation software that allows you to create custom webforms that populate data into your form...

Reviews

Overall rating

4.6 /5
(124)
Value for Money
4.5/5
Features
4.3/5
Ease of Use
4.5/5
Customer Support Software
4.7/5

Already have Qualio?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 124
John
John
Overall rating
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Qualio helps lead the way through our MDSAP recertification audit.

Reviewed on 2022-02-01

Qualio serves as my document repository, my "source of truth" for all required records within our...

Qualio serves as my document repository, my "source of truth" for all required records within our 13485/MDSAP compliant QMS. Recertification was completed in 2021 and the auditor noted the speed with which all document records were presented, without a backroom runner!

Pros

Software is easy to use and navigate, and to train others to use at different levels.
Record and report output is quick and organized.

Cons

Software has presented with many fix opportunities. That said the Qualio team is quick to remediate bugs and provide module upgrades that address new user needs!

Response from Qualio

Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well!

Pam
Overall rating
  • Industry: Medical Devices
  • Company size: 501–1,000 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Qualio Implementation

Reviewed on 2024-04-22

It is mainly positive, still early days, it would have been good to have more training and a more...

It is mainly positive, still early days, it would have been good to have more training and a more global presence for Qualio

Pros

Document control, supplier control, CAPA control

Cons

Setting up the system for our use was more complex than expected

Claire
Overall rating
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

Qualio has potential

Reviewed on 2024-04-12

Overall I think Qualio has a lot of potential. It has a lot of functions which just need slight...

Overall I think Qualio has a lot of potential. It has a lot of functions which just need slight improvements before they can be fully effective.

Pros

I like the version control of documents and that minor changes can be made without sending the document for re-training. Customer service is exceptional with issue and queries being addressed as soon as possible.

Cons

The 'compare against' function is not very useful as often it highlights entire sections of text instead of the specific changes. It also shows code when changes are made to tables or images.
The inability to revision control templates directly.
If templates update, changes within sections have to be applied manually to documents in draft.

Joel
Overall rating
  • Industry: Food & Beverages
  • Company size: 201–500 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Start up company with Qualio

Reviewed on 2024-04-17

Overall very happy, but it is my understand there may be some very significant price increases...

Overall very happy, but it is my understand there may be some very significant price increases coming our way which could cause us to look at alternate systems

Pros

*Customer Service
*Ease of initial installation
*Sandbox feature

Cons

*Suppliers module
*Improvement suggestions not always acted up efficiently

Kim
Overall rating
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

I would choose Qualio every time!

Reviewed on 2023-08-03

The speed of being able to receive comments or suggestions within the change control process has...

The speed of being able to receive comments or suggestions within the change control process has made the process of getting documents and events approved much more quickly and efficiently.

Pros

I like that it is easy to use and understand. The training documents and virtual assistance has been extremely useful in teaching new staff how to use the program.

Cons

The formatting capability of documents and information contained in events.

Showing 5 reviews of 124 Read all reviews

Qualio FAQs

Below are some frequently asked questions for Qualio.

Qualio offers the following pricing plans:

Please contact Qualio for pricing details.

Qualio has the following typical customers:

11–50, 51–200, 201–500

Qualio supports the following languages:

English

Qualio supports the following devices:

Qualio integrates with the following applications:

Asana, Azure DevOps Services, ComplianceWire, Confluence, Jira, Okta, TestRail, Xray

Qualio offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support, 24/7 (Live rep), Chat

Related categories

See all software categories found for Qualio.