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Un SGQ pour les entreprises d'appareils médicaux, pharmaceutiques et biotechnologiques. Conformité totale avec les normes ISO, de la FDA et GxP. Vérification cinq fois plus rapide des documents, formations, CAPA, NCR (Non-Compliance Report), audits, etc.
Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.
It is a bit tricky to understand the management of NCRs.
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Great eQMS software
Commentaires : This software is a quick and effective method of managing quality procedures. The system keeps track of everything. It is suitable for small businesses and is also scalable as they expand.
Avantages :
This software has a relatively simple learning curve. The programme has a lot of flexibility and lets you format procedures and records anyway you choose. The software contains useful features, easy-to-use interface, and finding documents is not too difficult either. Tech support is also excellent.
Inconvénients :
It's challenging to create documents with Qualio. The formatting options could be improved. Some areas lack audit trails.
Alternatives envisagées précédemment :
A Great Quality Management System to get you started.
Commentaires : I have been with Qualio for more than a year now and my company have bought into their first Quality Management System for the first time thanks to Qualios fantastic interface and ease of use. That is the priority for any QMS.
Avantages :
Qualio has a great user interface for anyone needing to create, edit, review, find and extract documents from a reliable document control system. This experience also spills over to their events module allowing me to personalise an audit and risk functionality that fit the mould of my companies quality journey. The Customer Service both supporting the induction of the platform and the every day query customer service is outstanding and could not compliment them more. The Help features of the platform make it easy for me to find quick assistance on what I need to do and the regular webinars are a blessing for me to understand what is in production to improve my experience with Qualio. Sandbox environment is great and much welcomes to play around before doing something you will regret in the live environment.
Inconvénients :
Qualio still have some sticking points with the document creation journey and while they are improving every day, they are still sorely lacking ease with the creation, reviewer and approval experience. Supplier event is also brand new and not quite the finished product yet. But its heading in the right direction.
Qualio is a great flexible QMS tool for small companies
Commentaires : 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.
Avantages :
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.
Inconvénients :
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.
Alternatives envisagées précédemment :
Customer Questionnaire
Commentaires : 100% document implementation into Qualio. Internal and third party audits directly from Qualio. Complete integration into Qualio for SD team and the sales and marketing team.
Avantages :
Aesthetically pleasing, Ease of use, ease of support, at a competitive cost. Qualio meets all expectations. Qualio gives us the ability to work remotely. This seems like the norm since Covid but the last few years cannot erase generations of employees being required to be in a brick in mortar location to work. Having our products available throughout the world keeps a little stability during a US economic downturn.
Inconvénients :
There is not a well defined way to get feedback to the Qualio team for improvement suggestions. The Qualio has addressed my ideas but there needs to be a ticket system with feedback from the suggestion. This just needs to be addressed as a system. A ticker could be made in Qualio and assigned to the IT department. The idea can be approved or denied. The ticket can be closed. Super simple.
Alternatives envisagées précédemment :
User friendly, sleek eQMS software
Commentaires : The implementation and support team from Qualio are knowledgeable, courteous and extremely helpful with the onboarding and implementation process making for a very smooth transition.The support team is also very responsive and open to suggestions for changes to the software, and software versions are implemented quickly and efficiently to improve based on customer feedback and needs.
Avantages :
The software is very intuitive and easy to use. We have little to no issues with implementation and understanding of how the system functions and documents/revisions move through the established workflows. New employees and users are onboarded into the program with relative ease.
Inconvénients :
The pricing and user license tiers/packages could use a bit of rethinking. It would be nice if Basic users (which are essentially read-only with access to Training and the Document Library only) did not take up a license from our annual subscription.Preferably, would like the user packages to be paid for only the Quality/Normal users that are actually creating and revising documents, or working on CAPAs, Nonconformances, Supplier Approval features, while Basic (read-only) users are able to login and view approved, effective documents for training purposes only without taking up a user license since they don't have access to the rest of the software's features.Other eQMS software and programs will have a separate training portal that can be accessed by any basic users without impacting the user licenses taken up.
Alternatives envisagées précédemment :
Qualio as a Quality Management Software
Avantages :
User interface and scalability/adaptability to business needs
Inconvénients :
Inability to lock values and text fields in Events and documents. Inability to run reports, or export data for tracking/reporting outside of Qualio. Interface with other data sets.
Alternatives envisagées précédemment :
Easy to use eQMS
Commentaires : Qualio has made our document management must simpler and easier to access. At our most recent audit, the auditor commented how much better structured our technical files were now that we had switched to Qualio
Avantages :
We've found Qualio is easy and intuitive for non-expert users to work with. Moving our most common forms directly into Qualio has cut out a lot of minor errors which in turn saves QA a lot of time.
Inconvénients :
It took us a bit of time to get our training set up properly although that was partly because we weren't clear what our aims were. When we first started the timings and content of updates was somewhat confusing, however the new system of planned and notified release schedules has made this much simpler and easier for users
Alternatives envisagées précédemment :
Qualio set up and execution
Commentaires : Training has become much easier.
Avantages :
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.
Inconvénients :
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 envisagées précédemment :
Qualio is the Perfect eQMS - Simple and easy to use
Commentaires : Experience overall has been great. Qualio has been super responsive to all questions and issues. They recognize where problems exist and where improvements can be made. They pay attention to the customer's requirements (needs and wants) and they implement them to improve the functionality and performance of the eQMS' features. Qualio is always working on new things to help facility the end user's IeQMS and remain compliant within the industry.
Avantages :
The ability to have all documents maintained electronically in one system. I managed a manual QMS for 13+ years...it was manageable, but Qualio made it so much easier! The change control element and the Training module was a huge bonus - especially when this was originally done manually all those years.
Inconvénients :
The cumbersome document editor seemed old and outdated and was not easy to use. However, Qualio has made many improvements to the document editor making it much easier to create and edit documents.
Excellent solution for most quality management systems
Avantages :
Almost endless configuration capabilities allowing the creation of documents and events that fit your QMS instead of rebuilding your QMS to fit the software.
Inconvénients :
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.
Qualio as a regulated quality management system
Commentaires : 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
Avantages :
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.
Inconvénients :
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
Réponse de l'équipe de Qualio
il y a 2 ans
Thank you for your thorough and excellent review, Barbara! We're happy to hear that our support team and customer resources have been helpful to you. Your feedback on training metrics and access customization has been relayed to our product team.
This is one of the most often used apps and was selected for its ease of use and compliance focus
Avantages :
- 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
Inconvénients :
- 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.
Réponse de l'équipe de Qualio
il y a 4 ans
Ease of use and compliance are key parts of Qualio's offering, so it's great to hear you're benefiting from these in particular. We're also pleased that you've found our support department so valuable. We will be continuing with this approach to customer service, and will take on board the improvements you have suggested. Thank you so much for your feedback Rob!
A true QMS for the Cloud
Avantages :
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.
Inconvénients :
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.
Réponse de l'équipe de Qualio
il y a 2 ans
Hi Karthi, thank you for your review. We're happy to hear of your team's smooth onboarding process and have shared feedback regarding documentation with our product team.
Perfect for Medical Device startups
Commentaires : 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.
Avantages :
Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation
Inconvénients :
Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.
Réponse de l'équipe de Qualio
il y a 4 ans
Thank you for your feedback Jonas we're pleased that Qualio was so key in achieving your ISO 13487 certification in such a short timeframe. Our software has since been updated with CAPA-handling capabilities, and we are always utilizing our customer feedback to enhance Qualio's features.
Qualio User Review
Commentaires : Has given our QMS a firm foundation
Avantages :
After the initial 'new interface' confusion which is normal for a new application, the product is actually very easy to use
Inconvénients :
Can't use existing documents as a template for new documents
Réponse de l'équipe de Qualio
il y a 2 ans
Thank you for your input, Daryl! We've provided your feedback to our product team.
Qualio review by CRO director
Commentaires : Overall the system looks good, easy to work with, not completely fulfulling all our needs though.
Avantages :
tracking of documents and CAPAs as well as ease of navigation in the system are great.
Inconvénients :
missing a project specific documents training tracker / training sign-off module
Réponse de l'équipe de Qualio
il y a 2 ans
Thanks for your review, Richard! We appreciate and have submitted your feedback to our product team.
Alternatives envisagées précédemment :
Focus on being a QMS
Commentaires : It’s been great, especially the team behind it. They have been super helpful.
Avantages :
That it’s focused on being a QMS and is not trying to solve all the world problems.
Inconvénients :
It’s a little difficult to navigate at first
Réponse de l'équipe de Qualio
il y a 2 ans
Thank you Kristinn, we're happy to hear you've had a positive experience with the Qualio team.
Qualio Review
Commentaires :
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!
Avantages :
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!
Inconvénients :
I am not sure at the moment. There were some Minor hitches with implementation . But no feedback on this yet!
A quick path to SOC II type II
Commentaires : 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.
Avantages :
User interface, ease of use, ability to get staff to love using it.
Inconvénients :
Nothing.
Réponse de l'équipe de Qualio
il y a 4 ans
It's always great to be told there are no cons to our software, so thank you very much for your positive feedback Colin! We're glad that we've enabled you to gain certifications quicker and unlock business growth.
Review of Qualio
Commentaires : Fast efficient way to manage quality processes.
Avantages :
Event and training managing is extremely useful.
Inconvénients :
Comments that are made to disapproving and retiring a document needs to be shown in the audit trail.
Réponse de l'équipe de Qualio
il y a 2 ans
Thank you for your review, Sandra! We've shared your feedback with our product team.
Very good user interface, ease of access and responsive tool
Commentaires : Overall QMS management efficacious and well used by the whole company
Avantages :
Easiness to find the documents and manage deviations/CAPAs
Inconvénients :
Customizing reminders not possible, this is useful to increase compliance and respect deadlines
Qualia is the Best Software for Documentation
Commentaires : Good Software for Good Documentation Practice (GDP).
Avantages :
It has a good login/ access process. It can be customized as per our Protocol Needs. The training part is also good, once the training is completed then you will come to know about the score. We can search documents easily. Good Software for Good Documentation Practice (GDP).
Inconvénients :
Switching from one page to another page while reading the document.
The greatest thing since sliced bread !!!!!
Commentaires : 5 STARS !!!
Avantages :
I liked the fact that it helps you meet requirements of ISO accreditation.
Inconvénients :
I can't think of a single issue that I have had.
Réponse de l'équipe de Qualio
il y a 4 ans
It's always great to be told there are no cons to our software, so thank you very much for your positive feedback David! We're glad that we've enabled you to meet the requirements for ISO accreditation quicker and unlock business growth.
Easy to use, hard to do wrong.
Commentaires : Better control of our documentation. Easy when the requirements from FDA is automatically handled.
Avantages :
Easy to make document updates and to send for review and approval.
Inconvénients :
It is a bit tricky to understand the management of NCRs . But I think it will be easier once you have used the system a bit more.
Réponse de l'équipe de Qualio
il y a 4 ans
Thanks for such great feedback Lisa. Our QMS is the only one that incorporates the latest practices like FDA, so it's fantastic that you're benefiting from this particular feature. We're sorry to hear you've had trouble with managing NCRs there's guidance available over in our docs section to assist: docs.qualio.com/functionailty-overviews/quality-events-overview
Still an immature product that limits item sizes.
Commentaires : It is decent, but needs improvement to be competitive.
Avantages :
The ability to assign training and create quizes.
Inconvénients :
The interface is not intuitive and document size is limited to only 100mbs. I create training decks that have AV content that is required for training. I always have to convert to pdf and the direct training outside of Qualio. Why use Qualio at all then?
Réponse de l'équipe de Qualio
il y a 2 ans
Thank you for your review, we've passed along feedback regarding document size to our product team.