What are Qualio users saying about the software?

Easy to use and implement eQMS

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

Great Software

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.

Needs basic improvements

Document Management works well

Pros

Training process works well. The system can generate reports for each employee.

Cons

Change control and periodic review reports need improvement. I cannot generate proper reports that provide visibility of these processes. The change control report is less than acceptable. Please fix this. I have explained this in the past.

Qualio as a regulated quality management system

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

Excellent people supporting an excellent product

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.

Qualio Review

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 helps lead the way through our MDSAP recertification audit.

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!

Very efficient, user friendly tool for our QMS

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.

Qualio Review

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!

Qualio EO

Pros

It is also very easy to learn because it is very easy to use. The interface is simple and very understandable.

Cons

It's a little more expensive than other software, but that's because it has better features.

Medical Device/Pharma CRO

Pros

This software is easy to use, intuitive, and straight forward. the search functions work well. The dash board is comprehensive and is critical is assessing status of activities.

Cons

The inability for a manger (such as myself) to have visibility to my direct reports training status as well as the status of other assigned activities for items that I have to manage. Our Quality group has full access but there is no intermediate option to control access to certain areas while allowing operational managers to be able to manage applicable information. So I have to resort to asking QA "where is this SOP in the approval process" , "who's training is outstanding", or " who started the draft version for a SOP?" etc. Since we are so restricted, it hurts work flow. Another layer, just below full access, to allow us to manage our over arching responsibilities, would be helpful.

The perfect system for startups and young organizations

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!

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

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.

Qualio user

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.

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.

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.

A true QMS for the Cloud

Pros

The level of learning required to understand Qualio is very light and I have noted that new staff learn how to use it very quickly. Being able to access the software over a browser is powerful without requiring special installations and access installed and setup on a PC.

Cons

It is not easy or flexible to create a document in Qualio. I still find myself reaching for Microsoft Word for the first draft of a document as I am familiar with page setup options, formatting and layout in that application. Qualio is useable but highly annoying to use.

User friendly platform

Being able to easily access crucial training documents and processes is paramount. Qualio makes it easy to locate and review said documents.

Pros

Our company uses Qualio to house our Quality Management System. The homepage is simple with links that are appropriate for diving into the system. The documents are clean and easy to read. Overall, I enjoy logging into Qualio and navigating the system to quickly get what I need!

Cons

The login process is split into two pages, enter email first then the password page appears. If the email and password pages could be grouped and the extra page eliminated, that would be ideal! Along with the option to remember the login credentials.

Qualio for the win !

We transitioned from a paper qms to Qualio and we save so much time for archiving, tracking and finding documents ! It is also much more easy and efficient to update documents.

Pros

Very nice users interface Easy to use contains mostly everything we need for an eQMS review and approval process flows well

Cons

- it would be nice if the NCR and CAPA module could be linked to in documents (hyperlink) - Currently the comments can only be placed at the end of each document section, however if a section is long it is not the most efficient way to put comment. Comment applicable directly to the text would be ideal.

Qualio User Review

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

Good for start ups

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.

Qualio review by CRO director

Overall the system looks good, easy to work with, not completely fulfulling all our needs though.

Pros

tracking of documents and CAPAs as well as ease of navigation in the system are great.

Cons

missing a project specific documents training tracker / training sign-off module

Qualio - Quality Control, Document Management and Traceability

Overall, the Qualio product has improved our workflow processing ability with excellent artifact collection and retention.

Pros

Qualio is a robust document management system with the ability to link documents and evidence for healthcare GRC needs as well as traceability in the process from cradle to grave.

Cons

The text editing features in Qualio are basic but strides are being taken to improve the features to meet most document composition and updating standards.

Good software for keeping up to date with documentation

Easy to use. Easy to find documents that you are looking for with search function

Pros

Training and searching, ease of finding and dowloading forms

Cons

I am not sure what liked least as for what ever I am using it it is doing a good job.

Focus on being a QMS

It’s been great, especially the team behind it. They have been super helpful.

Pros

That it’s focused on being a QMS and is not trying to solve all the world problems.

Cons

It’s a little difficult to navigate at first

A quick path to SOC II type II

With Qualio we were able to get SOC 2 Type II certified in about a year and a half, which is very impressive. This has lead to increased trust with our customers and helps us grow our business faster.

Pros

User interface, ease of use, ability to get staff to love using it.

Cons

Nothing.