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Über Qualio

QMS für medizinische Geräte, Pharma und Biotech. Vollständige FDA-/ISO-/GxP-Konformität. fünfmal schnellere Dokumentenkontrolle, Training, CAPA, NCRs, Audits und mehr.

Erfahre mehr über Qualio

Vorteile:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.

Nachteile:

It is a bit tricky to understand the management of NCRs.

Bewertungen zu Qualio

Durchschnittliche Bewertung

Benutzerfreundlichkeit
4,6
Kundenservice
4,8
Funktionen
4,3
Preis-Leistungs-Verhältnis
4,5

Weiterempfehlungsquote

8,7/10

Qualio hat eine Gesamtbewertung von 4,6 von 5 Sternen basierend auf 100 Nutzerbewertungen auf Capterra.

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Nutzerbewertungen filtern (100)

Mickey
Mickey
Controller in USA
Verifizierter Nutzer auf LinkedIn
Biotechnologie, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Great Software

5,0 vor 2 Jahren

Kommentare: It is very useful for anyone with or working towards ISO certification. Very audit friendly - would recommend.

Vorteile:

It is extremely straight forward to use. You can train managers quickly on it and use/adoption rate is very high.

Nachteile:

It is a bit pricey. However it is more versatile and easier to use than most major software - worth the extra costs.

Antwort von Qualio

vor 2 Jahren

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.

Dexter
Dexter
QA Document Speacialist in USA
Verifizierter Nutzer auf LinkedIn
Lebensmittelproduktion, 201–500 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

User friendly, sleek eQMS software

4,0 vor 7 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

In Betracht gezogene Alternativen: MasterControl Quality Excellence und QT9 QMS

Gründe für den Wechsel zu Qualio: Ease of use and features available for implementation.

Neil
Sr. Director of Quality in USA
Biotechnologie, 51–200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio is a great flexible QMS tool for small companies

3,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Karl
Quality and Compliance Director in UK
Pharmazeutika, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

A Great Quality Management System to get you started.

5,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

In Betracht gezogene Alternativen: MasterControl Quality Excellence und ServiceNow

Gründe für den Wechsel zu Qualio: Cost and the 'all in one' presentation was a huge reason.

Lowell
Director, Quality Assurance in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Customer Questionnaire

5,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

In Betracht gezogene Alternativen: Greenlight Guru

Gründe für den Wechsel zu Qualio: Ease of finding documents during an audit. Ease of change control for documents. Creating customizable forms. Reporting features. Assigning and keeping track of training records. Supplier ASL. One dashboard for all assignments.

David
Director Quality Assurance and Regulatory Affairs in USA
Medizinische Geräte, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Qualio as a Quality Management Software

5,0 vor 7 Monaten

Vorteile:

User interface and scalability/adaptability to business needs

Nachteile:

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.

In Betracht gezogene Alternativen: SAP S/4HANA Cloud und Greenlight Guru

Warum Qualio gewählt wurde: Compliance problems with current software and poor customer support to make required changes.

Gründe für den Wechsel zu Qualio: Best fit needs of business at the time.

Neil
Head of QA/RA in UK
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Easy to use eQMS

5,0 vor 6 Monaten

Kommentare: 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

Vorteile:

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.

Nachteile:

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

In Betracht gezogene Alternativen: SimplerQMS

Gründe für den Wechsel zu Qualio: Ease of use for infrequent users, ease of implementation

Savneet
Senior Quality Manager in USA
Kosmetik, 51–200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio set up and execution

5,0 vor 6 Monaten

Kommentare: Training has become much easier.

Vorteile:

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.

Nachteile:

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.

In Betracht gezogene Alternativen: QT9 QMS

Gründe für den Wechsel zu Qualio: Access to Qualio Quality staff and user-friendly system

Michele
Head of Regulatory & Quality Assurance in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Qualio is the Perfect eQMS - Simple and easy to use

4,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

In Betracht gezogene Alternativen: Polarion ALM

Gründe für den Wechsel zu Qualio: The price was a huge factor as well as the Design module.

Michael
QA Director in USA
Medizinische Geräte, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Excellent solution for most quality management systems

5,0 vor 6 Monaten

Vorteile:

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

Nachteile:

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.

Donna Lee
Director Toxicology in USA
Medizinische Geräte, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Medical Device/Pharma CRO

4,0 vor 2 Jahren

Vorteile:

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.

Nachteile:

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.

Antwort von Qualio

vor 2 Jahren

Hi Donna, thanks so much for your detailed review and insightful feedback regarding access control. This feature is in progress and we've relayed these details to our product team.

Thomas
QA Engineer in USA
Biotechnologie, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Qualio user

4,0 vor 2 Jahren

Kommentare: Very positive experience using Qualio. Qualio does offer weekly webinar trainings on many of the useful features. Qualio is easy to navigate.

Vorteile:

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.

Nachteile:

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.

Antwort von Qualio

vor 2 Jahren

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.

Gareth
Head of Quality in Neuseeland
Pharmazeutika, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Very efficient, user friendly tool for our QMS

5,0 vor 2 Jahren

Kommentare: Fantastic, coming from older clunky more expensive QMS at other Pharma companies, Qualio was a breath of fresh air.

Vorteile:

The workflows are very intuitive and with basic training a new user can navigate very easily.

Nachteile:

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.

Antwort von Qualio

vor 2 Jahren

Hi Gareth, thank you for your review and we're glad to hear Qualio has been efficient and easy to use thus far! We appreciate this insightful feedback and have shared with our product team.

Bastien
Production lead in Kanada
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio for the win !

5,0 vor 2 Jahren

Kommentare: 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.

Vorteile:

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

Nachteile:

- 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.

Antwort von Qualio

vor 2 Jahren

Bastien, we love to hear that you were able to successfully transition from paper to Qualio's eQMS! We appreciate the detailed feedback and have passed this along to our product team.

Melanie
CLinical Research Associcate in USA
Forschung, 501–1.000 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Great software for Required Training

5,0 vor 2 Jahren

Kommentare: I use Qualio daily to sign off on required training provided by my employer. It is easy to use and find documents.

Vorteile:

Qualio is very easy to navigate. The library of stored documents is easy to find. The main tab showing your assigned tasks on the homepage is a nice feature.

Nachteile:

N/A Very easy to use and find documents in the library.

Inge
CRA in Australien
Forschung, 201–500 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Good software for keeping up to date with documentation

5,0 vor 2 Jahren

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

Vorteile:

Training and searching, ease of finding and dowloading forms

Nachteile:

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

Antwort von Qualio

vor 2 Jahren

Hi Inge, we're happy to hear that Qualio is meeting all your needs and more! Thank you for your input.

Warrick
sys eng in Australien
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

simple and effective

4,0 vor 7 Monaten

Kommentare: Overall a huge improvement from the previous Sharepoint/paper based system.

Vorteile:

Qualio was quick to get used to for most of the workflows.

Nachteile:

Search functions are clunky. Document builder is ok but can be improved. Slow load time sometimes. Is there the ability to see other users draft docs? Need to be able to output the design controls into a doc and trace matrix.

Nihal
Nihal
Ceo in Kenia
Verifizierter Nutzer auf LinkedIn
Pharmazeutika, 201–500 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Qualio Review

5,0 vor 2 Jahren

Kommentare: 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!

Vorteile:

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!

Nachteile:

I am not sure at the moment. There were some Minor hitches with implementation . But no feedback on this yet!

Colin
CTO/CIO in USA
Krankenhausversorgung & Gesundheitswesen, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

A quick path to SOC II type II

5,0 vor 8 Jahren

Kommentare: 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.

Vorteile:

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

Nachteile:

Nothing.

Antwort von Qualio

vor 5 Jahren

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.

Sandra
Director of Quality in USA
Biotechnologie, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Review of Qualio

5,0 vor 2 Jahren

Kommentare: Fast efficient way to manage quality processes.

Vorteile:

Event and training managing is extremely useful.

Nachteile:

Comments that are made to disapproving and retiring a document needs to be shown in the audit trail.

Antwort von Qualio

vor 2 Jahren

Thank you for your review, Sandra! We've shared your feedback with our product team.

Fabio
VP Technology in Schweiz
Pharmazeutika, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Very good user interface, ease of access and responsive tool

4,0 vor 7 Monaten

Kommentare: Overall QMS management efficacious and well used by the whole company

Vorteile:

Easiness to find the documents and manage deviations/CAPAs

Nachteile:

Customizing reminders not possible, this is useful to increase compliance and respect deadlines

Achal
Project Manager in Indien
Forschung, 501–1.000 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualia is the Best Software for Documentation

5,0 vor 7 Monaten

Kommentare: Good Software for Good Documentation Practice (GDP).

Vorteile:

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).

Nachteile:

Switching from one page to another page while reading the document.

David
QA Manager in USA
Baumaterial, 10.000+ Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

The greatest thing since sliced bread !!!!!

5,0 vor 5 Jahren

Kommentare: 5 STARS !!!

Vorteile:

I liked the fact that it helps you meet requirements of ISO accreditation.

Nachteile:

I can't think of a single issue that I have had.

Antwort von Qualio

vor 5 Jahren

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.

Lisa
Head of QA/RA in Schweden
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Easy to use, hard to do wrong.

5,0 vor 6 Jahren

Kommentare: Better control of our documentation. Easy when the requirements from FDA is automatically handled.

Vorteile:

Easy to make document updates and to send for review and approval.

Nachteile:

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.

Antwort von Qualio

vor 5 Jahren

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

Max
Principal Field Clinical Specialist in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Still an immature product that limits item sizes.

3,0 vor 2 Jahren

Kommentare: It is decent, but needs improvement to be competitive.

Vorteile:

The ability to assign training and create quizes.

Nachteile:

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?

Antwort von Qualio

vor 2 Jahren

Thank you for your review, we've passed along feedback regarding document size to our product team.