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 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
VU
Verified User
Engineer in Research & Development (11-50 employees)
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.
VU
Verified User
Professional in Quality Assurance (11-50 employees)
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.
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.
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.
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.
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.
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.
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.
Qualio is our primary electronic document management system. It houses our company's procedures and records and manages several regulated quality functions, such as complaint handling and CAPA. Because the software is part 11 compliant, it is compatible with our heavily regulated business. Users find it intuitive to navigate using the navigation bar, and the software employs a very capable search engine for conducting audits, locating files, and compiling "where used" documents. The business uses the employee training module that tracks and automatically sends training assignment notices. Since the training module is within the software program, any procedure update automatically triggers retraining when the option is selected. Custom templates are easy to create, update, and apply to keep up with evolving Quality Management systems and regulatory requirements. The software supports links extensively, including providing easy open task access through individual employee dashboards. A review and approval process is managed within the software using compliant e-signatures. New modules are introduced to continuously improve the capability of the software system. Our business is in the process of implementing a supplier management module. With updates to the software come notices of changes in an audit trail, and validation packets to support validations when appropriate. Employee addition, role, and status are readily managed by the system administrators.
Pros
The software has a staged task module that allows a review and approval of individual stages of an activity. This is very useful for complaints and CAPAs.
The training module provides a view of training completion by groups, individuals, and by procedures. It also provides trending information and tracks overdue assignments.
The dashboard is a personal view of all open tasks, what those tasks are, when the tasks are due, and provides a link to go directly to that task. It can be for a training assignment, a procedure to review or approve, or an open document draft under construction by the individual, for examples.
The search engine allows a search for a document or group of documents by a number of criteria, including part of the title, a reference in the document, the template type, and a tag that is attached (tags are configurable), as examples.
Cons
The editor for creating documents can sometimes prove challenging, as it operates differently than MS Word. Tables can be created but cannot be picked up and moved.
The document change history, which is on a separate tab in the document configuration, is sometimes forgotten by the person creating or updating a document. Although I personally like the arrangement of change history not being embedded within the document content, it would be good to steer people back through that history tab after editing a document, because not all changes may be captured initially when creating a new draft.
The metrics provided for training include open and overdue assignments in the calculation of completed assignments. I would like the option of considering just the overdue assignments in the metrics
Likelihood to Recommend
This is one of the most user-friendly QMS programs I have used because it does not require lengthy training to navigate the system. We are able to bring on a new employee and have them start their own initial onboard training in Qualio with only a simple introductory message that shares a few key instructions. The available training in Qualio Help has proved very effective when needed. An individual can pick whatever training is appropriate at that moment and there will be instructions on demand on any topic related to Qualio operations. Qualio is relatively new software and is maturing with a responsive staff that releases new updates on a monthly, weekly, or even daily basis. It has grown incapability in the two years I have used it and it continues to evolve through customer inputs and looking at other state-of-the-art products. The staff listen and respond quickly compared to my past experiences with other QMS software. There is an opportunity for them to provide more and better features, but the gap is closing and the Qualio engineers have been very collaborative to work with, providing us opportunities to participate in their directions for growth.
