Qualio

Life Sciences Quality Management and Compliance

5 /5 (26 reviews) Write a Review!

Qualio Overview

What is Qualio?

Qualio is the easiest way for businesses in Healthcare & Life Sciences to manage Quality and Compliance.

Qualio automates the painful paperwork and processes required by regulators like the FDA for 2x faster accreditation and approval. It helps you work 5x faster than paper or traditional solutions to manage Document Control, Training, NCRs, CAPAs, Audits, Suppliers, Complaints and more.

Define workflows for approval and review. Create records with automated numbering and easy linking of related content. Capture approvals with digital signature and automatically notify users of approved documents. You can use Qualio to manage training with automated notifications, reminders and training lists. Ensure compliance with any regulatory body and generate comprehensive audit trails to further meet compliance.

All your data is securely stored and backed-up through Qualio. Using Qualio, you can reduce costs through streamlining time consuming workflows by 5x and lowering risk through automating the recording of key compliance information.

In addition, Qualio's simple and powerful reporting makes it easy to see what's happening in real-time. Utilize Qualio's partner network of experts to work with you through the software and provide you with the key knowledge you need. Qualio provides an intuitive interface and live support so you can get started immediately.

Qualio Overview

Pricing

Starting from
US$800,00/month

Pricing options

Free Trial
Subscription
Open Source
Value for money

Qualio's simple pricing starts at $800 per month and scales with your business.


Qualio Features

Devices
Business size
S M L
Markets
United States, Canada, United Kingdom, Australia, Germany
Supported Languages
English

Media

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Qualio Reviews

Qualio Reviews

Overall rating
5
/
5
Excellent
26

Very good
0

Average
0

Poor
0

Terrible
0

Value for Money
4,7
Features
4,8
Ease of Use
4,9
Customer Support
4,9
100% recommended this app
Andrew E.

Easy to use and implement eQMS

Qualio team was very supportive with the transition to an eQMS system.


Rob T.

This is one of the most often used apps and was selected for its ease of use and compliance...


Jonas T.

Perfect for Medical Device startups

Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark.


Pamela R.

Overall Experience

I find Qualio a brilliant software.


Drew M.

Perfect Start-up QMS System

My experience with Qualio has been positive. Everything from the initial communication, to the validation work, to the migration of existing documents into the system. The training and implementation to my team members was very easy as well. The system is extremely easy to use while maintaining the high level of quality that the biotech industry demands.


Andrew E.
Industry: Medical Devices
Company size: 11-50 Employees

Easy to use and implement eQMS

Used Daily for 6-12 months
Reviewed on 2020/04/30
Review Source: Capterra

Qualio team was very supportive with the transition to an eQMS system.

Pros

- Qualio team was awesome helping us migrate to their system
- streamlined employee quality training, SOPs, and overall QMS efficiency
- clear audit trail for signatures and approvals
- east to navigate and simple interface

Cons

- none thus far, we continue to find more and more value from this eQMS system

Response from Qualio

Thanks for the review, Andrew! So happy to hear you've enjoyed your experience so far.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Rob T.
Industry: Health, Wellness & Fitness
Company size: 201-500 Employees

This is one of the most often used apps and was selected for its ease of use and compliance focus

Used Daily for 2+ years
Reviewed on 2018/06/11
Review Source: Capterra

Pros

- ease of use! It's all right there, easy to find and easy to teach!
- compliance: we pull multiple reports from Qualio for our compliance audits and they are never questioned
- reporting: very thorough, detailed reports for training completion and distribution
- support listens to both feature requests and existing changes that are needed and addresses all promptly

Cons

- one feature that is missing is automatic reminders of incomplete assigned training (supposed to be on the roadmap, though!)
- most software will encounter an error now and then. While it is infrequent with Qualio, the error messages can be vague, prompting support calls that could be avoided with better detail.

Response from Qualio

Ease of use and compliance are key parts of Qualio's offering, so it's great to hear you're benefiting from these in particular. We're also pleased that you've found our support department so valuable. We will be continuing with this approach to customer service, and will take on board the improvements you have suggested. Thank you so much for your feedback Rob!

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Jonas T.
Industry: Information Technology & Services
Company size: 2-10 Employees

Perfect for Medical Device startups

Used Daily for 1+ year
Reviewed on 2016/08/10
Review Source: Capterra

Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark.

Pros

Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation

Cons

Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.

Response from Qualio

Thank you for your feedback Jonas we're pleased that Qualio was so key in achieving your ISO 13487 certification in such a short timeframe. Our software has since been updated with CAPA-handling capabilities, and we are always utilizing our customer feedback to enhance Qualio's features.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 9.0/10

Pamela R.
Industry: Medical Devices
Company size: 11-50 Employees

Overall Experience

Used Daily for 6-12 months
Reviewed on 2020/10/23
Review Source: Capterra

I find Qualio a brilliant software.

Pros

The software is very user friendly and simplified compared to other quality systems I used in the past.

Cons

During the initial set up phase some of the features weren't streamlined to get the validation completed but with Qualio's great customer service and technical support concerns were resolved fast.

Response from Qualio

Thank you for the great review and feedback, Pamela. We look forward to continuing to serve you.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Drew M.
Industry: Biotechnology
Company size: 2-10 Employees

Perfect Start-up QMS System

Used Daily for 1-5 months
Reviewed on 2020/08/27
Review Source: Capterra

My experience with Qualio has been positive. Everything from the initial communication, to the validation work, to the migration of existing documents into the system. The training and implementation to my team members was very easy as well. The system is extremely easy to use while maintaining the high level of quality that the biotech industry demands.

Pros

All required aspects of a quality management system are present in Qualio. Everything from the initial software validation, to the implementation and in software features like version control, track changes, electronic signatures, etc.

Cons

To date I have no cons to mention. Qualio is an incredible product for the price.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

User recommendation
9,8/10
Based on 26 user ratings
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Qualio Pricing

Qualio Pricing

Starting from
US$800,00/month
Free Trial
Subscription
Open Source
Value for money

Qualio's simple pricing starts at $800 per month and scales with your business.

Qualio's simple pricing starts at $800 per month and scales with your business.

Value for Money
4,7/5
Based on 26 user ratings
Compare value for money rating with alternatives
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Qualio Features

Qualio Features

API
Access Control
Activity Dashboard
Activity Tracking
Automatic Notifications
Chat
Collaboration Tools
Collaborative Workspace
Commenting
Customizable Branding
Document Management
Document Storage
Drag & Drop Interface
File Management
Permission Management
Projections
Reporting & Statistics
Search Functionality
Third Party Integration
Workflow Management
Features
4,8/5
Based on 26 user ratings
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Categories

Additional information for Qualio

Additional information for Qualio

Key features of Qualio

  • Action management
  • Activity tracking
  • Audit trail
  • Automatic reminders
  • Change management
  • Collaborative review
  • Corrective actions
  • Document review
  • HIPAA compliance

Benefits

- Designed for Medical Devices, Biotech, Pharma, Digital health and CxOs (Manufacturing, Testing Laboratories, Research Orgs)

- Maintain 100% compliance and audit readiness at all times.

- Set up automatic email notifications to reviewers and approvers.

- Real-time parallel approval process. All reviewers can view the same document and previous versions can be compared against each other.

- Easily collaborate. You can add comments and mark documents as reviewed to immediately notify the author.

- Send automatic training notifications via email to your team at any time.

- Stay compliant with 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.

- Everything is fully customizable. Create your own templates for documents, forms and records. You can even specify document numbering and approval processes.

Designed to help you comply with important quality standards Including:
- Quality management systems (ISO 9001)
- Medical Devices (ISO 13485)
- FDA Quality Systems Regulations (QSR)
- e-record keeping (FDA 21 CFR p11, Annex 11)

Qualio FAQs

Qualio FAQs

Below are some frequently asked questions for Qualio.

Q. What type of pricing plans does Qualio offer?

Qualio offers the following pricing plans:

Starting from: US$800,00/month

Pricing model: Subscription, Open Source

Free Trial: Available

Qualio's simple pricing starts at $800 per month and scales with your business.

Q. What are the main features of Qualio?

Qualio offers the following features:

  • Action management
  • Activity tracking
  • Audit trail
  • Automatic reminders
  • Change management
  • Collaborative review
  • Corrective actions
  • Document review
  • HIPAA compliance

Q. Who are the typical users of Qualio?

Qualio has the following typical customers:

Small Business, Mid Size Business

Q. What languages does Qualio support?

Qualio supports the following languages:

English

Q. What type of pricing plans does Qualio offer?

Qualio has the following pricing plans:

Subscription, Open Source

Q. Does Qualio support mobile devices?

We do not have any information about what devices Qualio supports

Q. What other apps does Qualio integrate with?

We do not have any information about what integrations Qualio has

Q. What level of support does Qualio offer?

Qualio offers the following support options:

FAQs, Knowledge Base, Online Support, Phone Support, Video Tutorials