Qualio

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

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

93%
recommended this app
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124 Reviews

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!

Todd
Overall rating
  • Industry: Semiconductors
  • 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

Qualio Implementation, QMS Creation, and ISO Audit.

Reviewed on 2024-04-17

Great experience, allowed me implement a company wide QMS, passing ISO registration audits both...

Great experience, allowed me implement a company wide QMS, passing ISO registration audits both times.

Pros

Simple but complex at the same time, great features.

Cons

Docuemnt formatting could be improve, but very good currently.

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.

Robert
Overall rating
  • Industry: Medical Devices
  • Company size: 2–10 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

AMM Qualio Review

Reviewed on 2023-08-08

My overall experience with Qualio is good. It has helped our company grow and pass many audits. It...

My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's.

Pros

The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good.

Cons

I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.

Jigar
Overall rating
  • Industry: Information Technology & Services
  • Company size: 201–500 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

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

Qualio Review

Reviewed on 2023-08-07

Yeah, it is good to use, good to show someone your documentation and completes the process flow...

Yeah, it is good to use, good to show someone your documentation and completes the process flow with respect to the features and configurations.

Pros

It is the best document management system which consist of whatever things you required with respect to ISO standards and as well as the company standards. It can be configurable. Best interface, controlled documentation, easy to use and to show external parties.

Cons

There are no such thing that i dislike, but some sort of feature incorporation while releasing a patch or full release can be taken as feedback from current users so that the new feature or full release can contains the things which are mostly required by the end users.

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.

Joe
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 7.0 /10

Qualio for biotechnology

Reviewed on 2024-04-17

Pros

Ease of use. Compliance with FDA, CE, and TGA requirements for QMS.

Cons

Nothing. The team really listens and implements changes requested by the customer.

Sonia
Overall rating
  • Industry: Health, Wellness & Fitness
  • 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 user review

Reviewed on 2024-04-17

My experinece with Qualio has been fine so far. I like that it send an out reminders every Monday...

My experinece with Qualio has been fine so far. I like that it send an out reminders every Monday and helps us keep tabs of days and deadlines.

Pros

I like that it is really easy to navigate and help centre works great, it really helps in every step of the way.

Cons

I don’t like the fact that it’s less flexible and with terms of document control and user permissions.

Dominika
Overall rating
  • Industry: Information Technology & Services
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

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

SdNcenter's review

Reviewed on 2024-04-22

Very professional and nice support with documents migration

Very professional and nice support with documents migration

Pros

A system that is user friendly, easy to set-up and meets all requirements of ISO 13485

Cons

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

Neil
Overall rating
  • Industry: Biotechnology
  • 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 is a great flexible QMS tool for small companies

Reviewed on 2023-08-16

Overall, my experience with Qualio is positive and I would recommend other small business owners to...

Overall, my experience with Qualio is positive and I would recommend other small business owners to purchase this system. The system was fairly easy and quick to implement and covers the basics of what is needed to establish an ISO based QMS. The customer service is excellent and it appears that they are trying to improve both the quality of the product and the features.

Pros

Qualio has great customer service and and the onboarding team was incredibly helpful in setting up the system quickly. The system has great flexibility in setting up customized processes using their Events feature and I'm excited to implement their new analytics features. The process for change control is simple and intuitive.

Cons

As compared to other eQMS systems, there seems to be some basic functionality that is missing. For example, change control must be applied to one document at a time where most eQMS can revise multiple documents at a time. The system does unfortunately have bugs throughout all of their modules and the editing tool and tracking changes tool is quite tedious and burdensome. Lastly, their design control module is really a requirements management tool and does not actually assist with design control.

Drew
Overall rating
  • Industry: Biotechnology
  • 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

Qualio for Biotech

Reviewed on 2023-08-31

Qualio is an affordable option that includes all of the features you would want to see in an...

Qualio is an affordable option that includes all of the features you would want to see in an electronic quality management system.

Pros

Qualio provides a seamless transition from the first inquiry to the product handover. Qualio is easy to use and implement which was the most important thing when selecting a system to use at my company. 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.

Cons

As with any system there are always features that you wish existed. However, Qualio does a great job at accepting ideas and implementing them over time.

Hideyuki
Overall rating
  • Industry: Alternative Medicine
  • Company size: 51–200 Employees
  • Used Daily for 1-5 months
  • Review Source

Overall rating

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

My review for Qulaio

Reviewed on 2024-04-24

Pros

I have not been using it long and have not been able to use all of its features, but so far I have not had any major problems with it. It is good to know what changes have been made. We will be using it for training in the future and would appreciate your dedication and cooperation when needed.

Cons

Change control is better for us and your support.

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

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 6.0 /10

User experience

Reviewed on 2024-04-17

Pros

Easy to update changes to the event forms

Cons

Audit trail and compliance risk as cannot view comments and detailed trail of an activity.

Michelle
Overall rating
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 9.0 /10

Qualio Review

Reviewed on 2023-08-03

Pros

Qualio is the first cloud-based QMS I've used and it was relatively easy to learn due to its no frills UI. Their platform is updated from time to time which improves the experience (for example, document editing and reviewing has been improved over the past couple years).

Cons

Perhaps out of scope, but Qualio would be great if it could be linked to some form of inventory management system. For example, in quality events sometimes specific materials need to be identified and currently there is a lot of double-entry in our system (Qualio, then in another spreadsheet or software). Also, there are some minor inconveniences that continue to exist, such as links that go to a superceded document. Perhaps there could be a feature which allows for smart linking to a specific version vs. most current version.

Salvador
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 501–1,000 Employees
  • Used Monthly for 6-12 months
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 8.0 /10

Reviewing Qualio

Reviewed on 2024-04-15

Pros

I think Qualio is a good tool to improve the training of the company's staff.

Cons

I think Qualio could be more visually appealing.

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

Overall rating

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

A User-friendly and Efficient System

Reviewed on 2023-08-08

Pros

Qualio is extremely easy to use, with a streamlined interface that ancitipates the user's needs. In doing this, it streamlines the time required to create, edit, and access documentation in a secure way, and does not require a large amount of training or time to get used to.

Cons

Small cosmetic and quality of life improvements are needed in specific areas, yet they are the exception to the rule in most cases and do not seriously impact the system's value.

Sasiporn
Overall rating
  • Industry: Research
  • Company size: 11–50 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

Always support, continuous improvement and system is really easy to use

Reviewed on 2023-08-12

Pros

flexible, able to customize as per company's requirments.

Cons

document editable format is still have some limit function

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.

jocelyn
Overall rating
  • Industry: Medical Devices
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Likelihood to recommend 5.0 /10

Not efficient to run report

Reviewed on 2023-08-08

Fair

Fair

Pros

It documented all the changes and updates.

Cons

Can't run report or easy access to report even though the data are in Qualio. Will be great if user can run a table report and export the information into excel sheet.

Kathy
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 501–1,000 Employees
  • Used Monthly for 2+ years
  • Review Source

Overall rating

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

Qualio

Reviewed on 2023-08-11

Very satisfied

Very satisfied

Pros

The features I like the best is ease of use.

Cons

In my opinion, there are no cons in using Qualio

jared
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 9.0 /10

Excellent people supporting an excellent product

Reviewed on 2022-02-01

Our Design Control process is much tighter. Document Control requires less time and effort. We...

Our Design Control process is much tighter. Document Control requires less time and effort. We have elevated our Risk Management game. Our Quality people are happier using such a well integrated tool.

Pros

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive. The materials available for on-boarding and learning are very well done and thorough. The built-in chat function for fast support is excellent - so easy to use. The people of Qualio are high caliber and there is clearly a culture of Customer Service. There is a very good balance between structure and customization - Qualio has found the sweet-spot. The SOPs and templates offered as a starting point are well written and concise.

Cons

I am hard-pressed to describe an aspect of the platform or the company that I would like to see changed. We do more than Medical Devices. We are in the process of considering how we might use Qualio outside of Medical and what would have to happen to accomplish such a goal - this is perhaps something Qualio might consider as an evolutionary initiative.

Response from Qualio

Hi Jared, thank you for your fantastic review and we're so happy to hear that Qualio has made life easier for your Quality team! We'd love to get more of your thoughts on scaling usage of Qualio outside of Medical Device and your CS contact can answer any questions you might have on this.

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.

Daryl
Overall rating
  • Industry: Wholesale
  • Company size: 2–10 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

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

Qualio User Review

Reviewed on 2022-01-27

Has given our QMS a firm foundation

Has given our QMS a firm foundation

Pros

After the initial 'new interface' confusion which is normal for a new application, the product is actually very easy to use

Cons

Can't use existing documents as a template for new documents

Response from Qualio

Thank you for your input, Daryl! We've provided your feedback to our product team.

Gareth
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 11–50 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

Very efficient, user friendly tool for our QMS

Reviewed on 2022-02-08

Fantastic, coming from older clunky more expensive QMS at other Pharma companies, Qualio was a...

Fantastic, coming from older clunky more expensive QMS at other Pharma companies, Qualio was a breath of fresh air.

Pros

The workflows are very intuitive and with basic training a new user can navigate very easily.

Cons

There is huge potential within Qualio to add on things like calibration management or Internal audits management. So it would be great to see additional modules / use cases added.

The ability to integrate with other systems is not very visible.

Response from Qualio

Hi Gareth, thank you for your review and we're glad to hear Qualio has been efficient and easy to use thus far! We appreciate this insightful feedback and have shared with our product team.