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About Qualio

QMS for Medical Devices, Pharma and Biotech. 100% FDA/ISO/GxP compliance. 5x faster Document Control, Training, CAPA, NCRs, Audits and more.

Learn more about Qualio

Pros:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.

Cons:

It is a bit tricky to understand the management of NCRs.

Qualio ratings

Average score

Ease of Use
4.5
Customer Service
4.7
Features
4.3
Value for Money
4.5

Likelihood to recommend

8.5/ 10

Qualio has an overall rating of 4.6 out 5 stars based on 124 user reviews on Capterra.

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Filter reviews (124)

Mickey
Mickey
Controller in US
Verified LinkedIn User
Biotechnology, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Great Software

5.0 3 years ago

Comments: It is very useful for anyone with or working towards ISO certification. Very audit friendly - would recommend.

Pros:

It is extremely straight forward to use. You can train managers quickly on it and use/adoption rate is very high.

Cons:

It is a bit pricey. However it is more versatile and easier to use than most major software - worth the extra costs.

Alternatives Considered: Greenlight

Reasons for Switching to Qualio: Greenlight also seemed like a great product but the implementation speed and ease of Qualio was out deciding factor.

Qualio Response

3 years ago

Hi Mickey, thank you for your review and we're happy to hear that Qualio has made your audit processes simpler and easier to manage.

Savneet
Senior Quality Manager in US
Cosmetics, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio set up and execution

5.0 2 years ago

Comments: Training has become much easier.

Pros:

User Friendly, Team that helps you onboard and provides help along the way is amazing!! Having access to Quality specialist is a big plus and both the onboarding manager and Quality specialist have been knowledgeable, patient and great. Feedback is taken positively and shared with internal teams.

Cons:

Complaints module - having editable udf's (feedback shared with Qualio team). Document collaboration could be improved. Tag- ability to type in a tag instead of selecting from a drop-down list. Categorizing tags in the drop-down Template- linking a template in documents. Sending a template for review prior to approval Forms- Revision control. Stamping a form with the form number automatically instead of a manual addition.

Alternatives Considered: QT9 QMS

Reasons for Switching to Qualio: Access to Qualio Quality staff and user-friendly system

Arslan
QARA Manager in Canada
Medical Devices, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Customer Support

3.0 10 months ago

Pros:

Customer Support is Amazing as I used to do regulars meeting with them

Cons:

Not user friendly as my CS team didn't like their complex processes

Hanifa
Quality Assurance Officer in Kenya
Pharmaceuticals, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

The solution to management of QMS activities and Events

5.0 9 months ago

Comments: It has been an interesting learning experience and the solution to the tedious manual QMS.
Work is simplified and distributed evenly.
Is a fairly lean system.

Pros:

Qualio has been improving every quarter to satisfy customer needs by incorporating suggestions for improvements made by customers and advancement of the feature available for use as per the current GMP regulations.

Cons:

One has to adapt very fast with the changes to enjoy the benefits. So much good not to miss out on the advantages.

Jonathan
Quality Assurance Manager in US
Biotechnology, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Quality is in it's name and it delivers!

5.0 10 months ago

Comments: I, and the company, have had a good experience with Qualio. Though there have been a few troubled spots we have always been reassured and received the improvements that have fixed issues. We are reassured that the Qualio team is working hard to give its clients the best quality management experience possible.

Pros:

Qualio is a platform that we've seen grow over the years. 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. Their service team ensures you have what you need, and diligently works to implement needed changes if a feature is not available. It's clean and navigable. I highly recommend it for smaller businesses or startups.

Cons:

We have waited on occasion past a couple of feature releases for much-needed editor and supplier management changes. The review process and audit trail are good, but change control (requesting approval to create drafts, risk assessment features, and tracking changes between versions) are lacking. Sometimes it shows large chunks of text as removed and replaced when only a few changes were made. Sometimes it shows all it's changes in rich text code which is unreadable for most.

Muhammad
GM QA and RA in Australia
Medical Devices, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Quality Review

4.0 10 months ago

Comments: Overall, the experience with Qualio is good so far.

Pros:

The best thing about Qualio is that you can customise it according to you own operations. The second-best thing about Qualio is their support team.

Cons:

Document management needs to be improved a bit. 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. This hinders the log control in Qualio.

Nesh
software engineer in US
Medical Devices, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio review

4.0 10 months ago

Pros:

I like that it is easy to use. Has good version control. It facilitates good review process

Cons:

Qualio does not keep resolved comments. When someone completes review and click ‘Mark as reviewed’ in Qualio, no email notification is received. For an existing table, adding multiple rows at a time is not possible. Only one row can be added. Unable to copy the contents across multiple rows. There is no functionality to replace one character string with another. Doesn’t notify if a particular reviewer completed review. Doesn’t allow comments by a particular reviewer if that reviewer completed review. Not possible to filter for comments from a particular reviewer. Can not add multiple rows in table. All documents in all states should be visible to all users. Can not delete comments.

chandini
Clinical data associate in India
Writing & Editing, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

The best app for using your and reviewing your documents during your work.

5.0 10 months ago

Comments: I must say that its the best and Excellent everyone must OWN.

Pros:

The things i like the most is the interface that the Qualio provides which is very user friendly and easy to access and its development through year is incredible

Cons:

I never saw anything that is troubling me in Qualio till date thats what made me impressed to use this daily at work.

Todd
VP of Quality Assurance in US
Semiconductors, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio Implementation, QMS Creation, and ISO Audit.

5.0 10 months ago

Comments: 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.

Brian
Quality Manager in US
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio disappointing

4.0 10 months ago

Comments: Poor - I came in late (hardly anything was done) with the implementation and just wasn't aware of the capabilities of Qualio, and Qualio was backing out of the on-boarding process. I don't believe Qualio provided me with a good understanding of the capabilities of the system and how best to set it up.

Pros:

I do like the Document Lifecycle management and the control of documents. Need the ability to have separate libraries, (i.e for Technical Documents) and not by tag!

Cons:

Cost....Not much of a value when compared to manual systems 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!) I also resent the price increase applied this past year and the inability of Qualio to negotiate or justify the increase. We are actively evaluating other suppliers.

Drew
Director of Quality in US
Biotechnology, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio for Biotech

5.0 last year

Comments: 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
Managing Director in Japan
Alternative Medicine, 51–200 Employees
Used the Software for: 1-5 months
Reviewer Source

My review for Qulaio

5.0 10 months ago

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.

Neil
Sr. Director of Quality in US
Biotechnology, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

Qualio is a great flexible QMS tool for small companies

3.0 2 years ago

Comments: 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.

Adrianna
Training specalist in US
Nonprofit Organization Management, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio is AMAZING!

5.0 10 months ago

Pros:

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

Cons:

I wish you could have document folders to separate materials

Riikka
Ho Regulatory and Scientific Affairs in Finland
Medical Devices, 2–10 Employees
Used the Software for: 6-12 months
Reviewer Source

Extremely satisfied with Qualio

4.0 2 years ago

Comments: Overall very satisfied

Pros:

The whole management of quality system became so pleasant with Qualio compared to manual QMS. All the way from the purchase to implementation to going live all the needed support was available.

Cons:

The process of implementing experienced some hick-ups with Qualio's change of employees... Document creation and management is still a bit non-optimal because text modification as in e.g., Microsoft Word is quite limited

Judson
Plant Manager in US
Chemicals, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Outstanding eQMS!

5.0 2 years ago

Comments: We control almost every aspect of our manufacturing business in Qualio along with our MES. We love the system.

Pros:

We easily pass cGMP complaince audits utilizing all features of Qualio. The ease of use and being able to quickly pull up any documents requested has impressed many auditors.

Cons:

Initially the search feature was a bit clunky, but there has been improvements. No issues now.

Janelle
Biomanufacturing Lead in Canada
Biotechnology, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Easy to Use

5.0 2 years ago

Pros:

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

Cons:

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.

Jessica
Chief Commerical Officer in US
Medical Devices, 2–10 Employees
Used the Software for: 6-12 months
Reviewer Source

Beware, Qualio is not a Turnkey Solution

2.0 2 years ago

Comments: 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.

Fabio
VP Technology in Switzerland
Pharmaceuticals, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Very good user interface, ease of access and responsive tool

4.0 2 years ago

Comments: Overall QMS management efficacious and well used by the whole company

Pros:

Easiness to find the documents and manage deviations/CAPAs

Cons:

Customizing reminders not possible, this is useful to increase compliance and respect deadlines

Verified Reviewer
Verified LinkedIn User
Information Technology & Services, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio to manage SOP DOP

4.0 last year

Comments: Used for Documents Controlling and ISO certificates management. Train all the users on SOP and DOP through Qualio

Pros:

Document Control is at best. We can easily manage documents version in with version history.

Cons:

When you see version difference, it sometimes show html code level changes of document, which looks irritate.

Syed Aamir Ali
Mems test engineer in Finland
Semiconductors, 11–50 Employees
Used the Software for: 1-5 months
Reviewer Source

A useful tool

4.0 2 years ago

Comments: the overall experience is positive.

Pros:

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

Cons:

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

Thomas
QA Engineer in US
Biotechnology, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio user

4.0 3 years ago

Comments: Very positive experience using Qualio. Qualio does offer weekly webinar trainings on many of the useful features. Qualio is easy to navigate.

Pros:

Qualio is very customizable. We have built our QMS using Qualio and being that it is cloud based it is available in house or remotely. Documents are easily shared with other members of the team. The support staff at Qualio is outstanding.

Cons:

I feel if Qualio had a bulk download feature where you are able to do a download of all of the documents to a secondary location for data redundancy, that would be helpful. Currently you can download the documents, but is is a single download, and not the entire QMS.

Qualio Response

3 years ago

Hi Thomas, thank you for your wonderful review and we're so happy to hear you're enjoying Qualio's customizable features and easy navigation. We're sharing your feedback regarding bulk downloads to our product team.

Kristi
Associate Director of Quality in US
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Good for start ups

4.0 3 years ago

Comments: Overall, as a small startup it worked for our needs. As we grew and more people from larger companies joined, there were struggles. I think if you are open to making Qualio work for you and you have stakeholders onboard during implementation its great. If you bring people in who are used to expensive widely used tools its a learning curve. I would use it again if I were starting a company.

Pros:

I liked the ability to build and edit the event flows (NCR, CAPA, etc).

Cons:

Redline feature is not great right now.

Nihal
Nihal
Ceo in Kenya
Verified LinkedIn User
Pharmaceuticals, 201–500 Employees
Used the Software for: 1-5 months
Reviewer Source

Qualio Review

5.0 3 years ago

Comments: We have a very high Qa workload and especially during inspections were reliant on a couple of people. One thing forgotten or not done on time can lead to critical or major reviews. We want to avoid that and also ensure the QA managers are using their time effectively and not chasing paper. We are still
Completing implementation and will be able to measure the efficiency, time saved and capacity developed by end of the year!

Pros:

I think the ease of implementation and support. Ease of use… “does what it says”. We still need more time with it but my employees seem excited about it!

Cons:

I am not sure at the moment. There were some Minor hitches with implementation . But no feedback on this yet!

Cynthia
Vice President, Regulatory Affairs in US
Medical Devices, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

Qualio Review

5.0 3 years ago

Comments: I am very satisfied with Qualio.

Pros:

Ease of use, search feature, and the dashboards for overdue training, deviations.

Cons:

Quality events feature is a little confusing.

Alternatives Considered: Veeva QualityOne EQMS

Reasons for Switching to Qualio: Cost and ease of use.

Qualio Response

3 years ago

Hi Cynthia, we're happy to hear that so many of Qualio's features are enabling your QMS processes. If you'd like to provide any additional details on improvements to our Events feature, please feel free to reach out to me directly.