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About Qualio

Cloud-based QMS to optimize processes and ensure regulatory compliance.

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

Alternatives Considered:

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.

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

Alternatives Considered:

Qualio set up and execution

5.0 last year

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.

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

Customer Support

3.0 8 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 7 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 8 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 7 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.

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 8 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.

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

Qualio review

4.0 8 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.

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

Qualio disappointing

4.0 7 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.

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 8 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.

Michael
QA Director in US
Medical Devices, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Excellent solution for most quality management systems

5.0 last year

Pros:

Almost endless configuration capabilities allowing the creation of documents and events that fit your QMS instead of rebuilding your QMS to fit the software.

Cons:

Inability to hot-swap an approver when they are not available. Instead the document needs to be reverted to draft, the approver changed, and then the document rerouted.

Laura
VP, Quality in US
Pharmaceuticals, 201–500 Employees
Used the Software for: 2+ years
Reviewer Source

Choose Qualio for your eQMS needs

5.0 last year

Comments: They have been a wonderful partner for over 5 years. I have worked with many QMS and Qualio is by far the easiest and most useful system I have ever worked with. A really important fact is that the support team at Qualio is about the best I have seen in the industry. They are responsive, well trained, and understand the criticality of getting you answers and assistance ASAP. Can't say enough about the support team... they are wonderful.

Pros:

Qualio is simple to implement, maintain, deploy and use. It has a very straightforward administration and implementation.

Cons:

As with any QMS, there are small things that could be improved. The editor is constantly being improved - which is great. One of the things that might have the most impact is if they could tailor it to "manager" users... so managers could see their employees training on procedures... assign documents for training, etc. instead of needing to go through the system administrators.

Michael
Sr PD Engineer in US
Biotechnology, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

An excellent software for newer startups focused on Quality.

5.0 last year

Comments: 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.

Caldin
Quality control manager in Kenya
Pharmaceuticals, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Best eQMS

5.0 last year

Comments: It's the best eQMS I have used so far

Pros:

The access controls , events segmentation and the audit trail feature.

Cons:

It could be better for each lauch train to have an independent industry centric webinar for trainings

Khyati
Quality Assurance in UK
Pharmaceuticals, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

User experience

3.0 8 months ago

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
Production Manager in Canada
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Qualio Review

4.0 last year

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.

TAYDIS
Regulatory Affairs and Document Control in US
Medical Devices, 51–200 Employees
Used the Software for: 6-12 months
Reviewer Source

Easy to use

5.0 8 months ago

Pros:

User friendly. Training, electronic signatures.

Cons:

Good experience so far. I like everything about Qualio.

Sasiporn
Clinical Quality and Training Manager in Thailand
Research, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

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

5.0 last year

Pros:

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

Cons:

document editable format is still have some limit function

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 last year

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.

Peggy
ACRM in Taiwan
Biotechnology, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

User

5.0 last year

Pros:

The plamform is simple. It can be sorted and search by keyword. Any new training, it will release letter to inform users.

Cons:

1) Training vedio can not be watched in the platform.2) CAPA creation is make by special users. When I use VeevaVault before, it can be created by any users.3) For almorst due training, I do not see the reminder letters. (maybe I missed them.)

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 last year

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

Alternatives Considered:

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.

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.