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/month

  • 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, Belgium, Canada, Denmark, Finland and 18 others

Supported Languages

English

Pricing starting from:

US$0.00/month

  • 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: 91

  • API
  • Access Controls/Permissions
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Assessment Management
  • Audit Management
  • Audit Planning
  • Audit Trail
  • Change Management Software
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Content Management System (CMS) Software
  • Controls Audit
  • Corrective and Preventive Actions (CAPA)
  • 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
  • Process/Workflow Automation
  • Quality Assurance
  • Quality Control
  • Real Time Data
  • Real Time Reporting
  • Real-Time Analytics
  • Real-Time Notifications
  • 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 Management
  • Trend Analysis
  • User Management
  • Version Control
  • Workflow Management Software

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Document Control

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Greenlight Guru

4.5
#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
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Reviews

Overall rating

4.6 /5
(101)
Value for Money
4.5/5
Features
4.3/5
Ease of Use
4.6/5
Customer Support Software
4.8/5

Already have Qualio?

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

Showing 5 reviews of 101
Verified Reviewer
Overall rating
  • Industry: Biotechnology
  • Company size: 11–50 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

The perfect system for startups and young organizations

Reviewed on 2019-01-17

Pros

I like the simplicity of the software, and the ease of configuration for the user. If a new document type is needed, it's literally just a few clicks away. I like the intuitive navigation and the ease of adoption by the end users.

Cons

At this time, the only place I can fault Qualio is in the data reporting capabilities. Running basics like how many open/closed NCRs or how many SOPs approved is fine, but without more capability built out, or an external API (like a BI report or crystal intelligence tool), I can't get to more data within records. I do know they are working on this however, and generally at the start up level, you're not yet in need of super detailed reporting within your QMS yet anyway. The basics they provide will more than get you off the ground!

Response from Qualio

An intuitive and simple interface is at the core of Qualio's software, so it's fantastic that you've really benefited from this. Thank you for your feedback on our data reporting capabilities too we are looking to rollout improvements to this functionality soon.

Barbara
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 as a regulated quality management system

Reviewed on 2022-02-02

Tech support is superior. They listen to suggestions and resolve problems quickly. I fully exercise...

Tech support is superior. They listen to suggestions and resolve problems quickly. I fully exercise the flexibility of the software without having to worry about obsolescence. The help videos and FAQ's are excellent

Pros

The software has flexibility in its use of configurable templates that allows custom formatting of procedures and records, although a basic set of templates is provided if customization is not needed. The audit trails are easily accessible and provide good detail. The Events module allows documenting actions that require staged approvals and tracking progress. Event types can be created and customized. The Dashboard is a quick view of all open tasks. Qualio is constantly improving and expanding their SW features.

Cons

Training metrics are not customizable. There is not a suspended status for people on extended leave, such as for pregnancy. the arrangement to provide limited access to some records could be better designed

Response from Qualio

Thank you for your thorough and excellent review, Barbara! We're happy to hear that our support team and customer resources have been helpful to you. Your feedback on training metrics and access customization has been relayed to our product team.

Jessica
Overall rating
  • Industry: Medical Devices
  • Company size: 2–10 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 0.0 /10

Beware, Qualio is not a Turnkey Solution

Reviewed on 2023-08-03

The drafted documents and form templates make starting easier, but they must be tailored to the...

The drafted documents and form templates make starting easier, but they must be tailored to the company's needs, which requires a quality person. Plus, just having the documents does not create a quality system. Please don't be fooled by the pitch that Qualio is a turnkey solution. Be aware that Qualio will not let you out of your contracted commitment.

Cons

It is not easy to create QMS with the documents alone.

Stephanie
Overall rating
  • Industry: Medical Devices
  • Company size: 2–10 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

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

Qualio review

Reviewed on 2023-08-09

Implementing Qualio was easy, especially with the prewritten SOP's that could be adapted to the...

Implementing Qualio was easy, especially with the prewritten SOP's that could be adapted to the client needs. Qualio has been great for maintaining the quality system from Complaints, NCR's, CAPA's etc.

Pros

Templates are helpful in guiding content creation across the organization. Events are great for managing approvals and maintaining evidence.

Cons

Training module doesn't provide a matrix type status, i.e. Documents versus all used and training requirements/status. Document identification did not allow for using predicate quality system document numbers.

Michael
Overall rating
  • Industry: Biotechnology
  • Company size: 2–10 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

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

An excellent software for newer startups focused on Quality.

Reviewed on 2023-08-09

Overall, feel like value for dollars spent, an excellent system for first implementation. Qualio...

Overall, feel like value for dollars spent, an excellent system for first implementation. Qualio staff are reachable.

Pros

The e-QMS feature and pairing with Adobe makes this a eco-friendly and high quality QMS. Drafting, review, approval and change management are intuitive.

Cons

Inability to view what the exported PDF looks like. Makes it difficult when working with data table entries.

Showing 5 reviews of 101 Read all reviews

Qualio FAQs

Below are some frequently asked questions for Qualio.

Qualio offers the following pricing plans:

  • Starting from: US$0.00/month View Pricing Plans
  • Pricing model: Subscription
  • Free Trial: Not Available

Please contact Qualio for pricing details.

Qualio has the following typical customers:

Self Employed, 2–10, 11–50, 51–200

Qualio supports the following languages:

English

Qualio supports the following devices:

Qualio integrates with the following applications:

Asana, Azure DevOps Services, ComplianceWire, Confluence, Jira, Jira Work Management, 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.