Qualio Reviews & Insights

Score6.9 out of 10

22 Reviews and Ratings

Community insights

TrustRadius Insights for Qualio are summaries of user sentiment data from TrustRadius reviews and, when necessary, third party data sources.

Pros

Staged task module: Users appreciate the software's staged task module, which allows for the review and approval of individual stages of an activity. This feature has been mentioned by several reviewers as particularly useful for handling complaints and CAPAs.

Comprehensive training module: The training module in the software provides a comprehensive view of training completion by groups, individuals, and procedures. Many users have praised this feature for offering trending information and tracking overdue assignments.

Efficient document search engine: The software's search engine allows users to easily locate specific documents or groups of documents based on various criteria such as title, reference, template type, or attached tags. Several reviewers have mentioned how this flexibility and efficiency in document searching has been beneficial to their workflow.

Qualio Reviews

16 Reviews

Easy to use for managing daily office regulations and policies.

Rating: 8 out of 10

Incentivized

July 28, 2025

Use Cases and Deployment Scope

We can quickly access any office policy to support customers by searching with a single keyword. We advise new team members to use Qualio for instant and accurate policy and procedure information. I appreciate Qualio Team for this.

Pros

Readily available policy documents to access any at any time which we wanted to access.
Quickly identify, understand and compare the older and newer version difference of the SOPs and to understand the changes which have made.
all the SOPs DOPs at the same place with secured access.
Particularly the upgraded version of Qualio is so classic and the dashboard and menus are easily able to understand to any new user as well.

Cons

The dashboard currently does not provide a search box or export feature.
The current session timeout is too short.
We are often logged out while reviewing documents, forcing them to re-login when returning to Qualio.
add on more flexibility in defining user roles and permissions what is currently available for the companies for better manage the access and smoothen the working process.

Likelihood to Recommend

Once logged in, navigate to the dashboard to easily view the latest and upcoming policy changes. We rely on Qualio for our day-to-day operations, which significantly improves our ability to provide quick and accurate customer support. Qualio's user-friendly navigation system helps us locate documents efficiently. While searching, clicking on a desired flag name instantly shows all associated documents. I'd like to use Qualio often.

Hardik Bhatt

L2 Support Engineer in Information Technology at StayInFront (201-500 employees)

Vetted Review

3 years of experience

Verified on LinkedIn

With a little work and regulatory input this system can function

Rating: 2 out of 10

June 27, 2025

Use Cases and Deployment Scope

Qualio was used in our organization for a limited period of time. The system had originally been purchased in order to streamline processes and to create an electronic batch record. The organization had begun implementation of the document control module, but that is as far as we had gotten at the time of my arrival. We had also assessed training and custom modules as well.

Pros

User friendly
Searchability within documents
Navigation

Cons

Not compliant with FDA regulations
Audit trail issues
Metadata issues

Likelihood to Recommend

I think that Qualio can work for some organizations, but not all. I dont think it is well-suited for a pharmaceutical or medical device company, but this could work for a company that doesnt require FDA oversight, computer system compliance, audit trails, etc. Perhaps this would be useful at an organization where only storage and receipt of documents is tracked, but not necessarily to the level of detail that is expected in the industry

Verified User

Engineer in Research & Development (11-50 employees)

Vetted Review

1 year of experience

Great and diverse system.

Rating: 9 out of 10

Incentivized

June 26, 2025

Use Cases and Deployment Scope

We utilize Qualio for the management of all our quality documents, implementation of our training program, supplier approval, equipment-related documentation management, and investigation of quality events. Having all of these different services streamlined into one system has been a game-changer for us in terms of efficiency.

Pros

Integrates multiple services into one system.
Allows for collaboration through editing and review of documents.
Allows for customization to fit our particular organization's needs.

Cons

Formatting of documents often gets messy/tricky.
Supplier records should have a spot to set a Next Review Due Date.

Likelihood to Recommend

We find it to be very well suited for a small GMP contract laboratory. It meets many of our needs - document management, training, supplier records, and investigation events. I'm not sure how efficiently it would work for a large organization.

Verified User

Professional in Quality Assurance (11-50 employees)

Vetted Review

4 years of experience

I was very satisfied with Qualio!

Rating: 10 out of 10

Incentivized

July 28, 2022

Use Cases and Deployment Scope

Qualio enables us to create managed documents and records in a more integrated environment. With Qualio, we are able to create quality management documents such as forms, work instructions, policies, SOPs and other related content. Some of the key problems solved by Qualio in my organization include maintaining our Document Control, Quality Event, Training, and Supplier Programs.

Pros

Document control
Training
Integrating teams, processes, and documents throughout the organization

Cons

I would appreciate if similar documents are grouped together. For instance if engineering documents are put in one category and management document in a different category
Qualio has links to external documents but it would be helpful if it linked the user to sections within the document also
I would prefer that users be able to purchase licences directly without contacting a representative

Likelihood to Recommend

Based on my experience, Qualio is best suited in aiding document control, supplier programs, training, team collaboration, and overall compliance, besides, Qualio is best suited for an organization that wants to eliminate the use of paper and bring a more easy system onboard. Essentially, Qualio is best suited to eliminate human error and creating a more effective quality management system.

Maureen Njeru

Engineering Specialist in Engineering at Burns & McDonnell (5001-10,000 employees)

Vetted Review

2 years of experience

View profile

Qualio to the rescue!

Rating: 10 out of 10

Incentivized

July 1, 2022

Use Cases and Deployment Scope

My last company onboarded Qualio to assist with the maintenance of our Document Control, Training, Quality Event and Supplier programs

Pros

Supplier Control
Document Control
Event Notifications
Team Collaboration
Overall Compliance

Cons

Reporting exporting
Formatting of Documents
Nomenclature - allowing clients to use their own/already existing

Likelihood to Recommend

Qualio did a great job in really controlling our QMS with less labor on staff to follow up for things needed in a timely manner.

Verified User

Manager in Quality Assurance (11-50 employees)

Vetted Review

3 years of experience

Great fit for a software medical device company

Rating: 8 out of 10

Incentivized

May 31, 2022

Use Cases and Deployment Scope

We use Qualio as a software medical device quality management system as well as a document management system for other quality and information security applications.

Pros

Is flexible enough to customize for use for different types of medical devices, enabling us to integrate it into our processes and support our quality automation initiatives.
Supports a distributed/remote workforce by enabling electronic record-keeping and signatures.
Generally supportive of the quality system regulations we are subject to.

Cons

The search function is poorly implemented and should be improved.
There is a tendency to rollout new features before they are robustly tested. We would prefer not to be the user acceptance testing.

Likelihood to Recommend

Qualio is much better than a manual QMS system, especially for a distributed/remote workforce and for medical devices. It is flexible enough to adapt well to a pure software medical device. Qualio's strength is that it enables customization/adaptation to fit the users' needs and is not overly prescriptive in most cases.

Jen Baird

Co-Founder, Chief Executive Officer, Director in Corporate at Fifth Eye Inc. (11-50 employees)

Vetted Review

3 years of experience

View profile

Qualio User

Rating: 9 out of 10

Incentivized

May 31, 2022

Use Cases and Deployment Scope

The platform Qualio Is the Quality Management System used At the Dot Corporation, a contract Labeler / Manufacturer company, in the Fulfillment and Distribution department, to control the manufacture, labeling, and distribution processes, and aftermarket vigilance activities for medical devices and to maintain the organization's compliance with the ISO13485 and ISO 9001 Standards.

Pros

Qualio Plus offers excellent professional counseling and expertise in Regulatory and Quality assurance areas.
The platform is very intuitive and easy to use.
The reporting tools are excellent, easy to pull out reports of KPIs, and makes it very easy to read data.

Cons

By the time I used the platform one area that needed more development was the supplier management tools. This may have changed by now.
At the beginning the text editing tools were very limited.
No mobile app

Likelihood to Recommend

For a small-sized company that is starting in a heavily regulated field like pharmaceuticals or medical devices, Qualio is without a doubt the best choice. It is very easily tailored to the organization's specific needs and the customer success teams are very professional and talented, they will make the adoption and deployment of the QMS a very easy task. It may be difficult for a bigger organization with a more embedded quality culture to transition to a system like Qualio as it has scalability challenges.

Verified User

Manager in Quality Assurance (51-200 employees)

Vetted Review

1 year of experience

Quality is Qualio!

Rating: 9 out of 10

Incentivized

May 27, 2022

Use Cases and Deployment Scope

Good software for using QMS, easy to set up and use.

Pros

Qualio is a really simple and easy to use program.
Users require very minimal training to navigate the system.
Possibility of easily writing and editing documents from the software.
In the dashboard, you can see all of your pending and completed trainings.

Cons

The search tool is just not efficient.
A number of users have a maximum limit. It is not possible to select a seasonal employee or intern.

Likelihood to Recommend

The user interface of Qualio is pretty simple. The Qualio Plus subscription is an excellent value. With users dispersed and working from different locations, a web-hosted QMS with a certified electronic signature is a necessity. For revision control, smart links eliminate the requirement for cross-references across documents. It's a good all-in-one QMS platform.

Verified User

Representative in Corporate (51-200 employees)

Vetted Review

1 year of experience

Happy to utilize Qualio as our eQMS system.

Rating: 10 out of 10

Incentivized

May 25, 2022

Use Cases and Deployment Scope

We utilize Qualio as our electronic quality management system. Prior to Qualio we had utilized a paper-based system and upgraded to Qualio. The reason we moved to Qulaio was to eliminate paper, bring an easy-to-use system in-house, and ultimately eliminate human error which can be a result of using a paper system.

Pros

Training
Document creation, reviews, revisions
Events (deviations, equipment complaints, customer complaints, etc.)
Reporting
An easy to use dashboard custom to each user

Cons

Qualio does not currently offer electronic batch record capabilities. However, we are still able to generate paper batch record and upload then into Qualio.

Likelihood to Recommend

During my initial phase of selecting an eQMS system to utilize, we evaluated 4 systems and ended up selecting Qualio. I needed to select a system that was easy to use to ensure all employees could be trained quickly and so that the system had all of the major functions that any quality management system would require. We also required a system that could be validated and would hold up when audits are conducted.

Drew Mateya

Director of Quality in Quality Assurance at ECM Therapeutics Inc. (11-50 employees)

Vetted Review

3 years of experience

View profile

How does Qualio stack up as an eQMS solution for QMS implementation for medical devices?

Rating: 7 out of 10

Incentivized

May 25, 2022

Use Cases and Deployment Scope

The company is a startup with no prior experience with medical device development or quality management. It is being implemented to support ISO 13485:2016 and 21 CFR 820 certifications for obtaining CE for EU and ARTG listing in Australia. The scope is a full implementation, training, and maintenance, and as a consultant, I have been given that responsibility.

Pros

Document and record control
Risk management
Design and Development

Cons

Attachment of records without need to change revisions or keep in Draft
Training records for groups
CAPA escalation process and review of metrics

Likelihood to Recommend

Very suited to managing documents and records although cannot download word versions of documents and records but can with forms.
Well suited to managing D&D and risk assessments.
Not so good at managing training or suppliers.

Verified User

Consultant in Quality Assurance (11-50 employees)

Vetted Review

Reseller

1 year of experience