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
4,6

Weiterempfehlungsquote

8,8/10

Qualio hat eine Gesamtbewertung von 4,7 von 5 Sternen basierend auf 60 Nutzerbewertungen auf Capterra.

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Nutzerbewertungen filtern (60)

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 6 Monaten

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.

In Betracht gezogene Alternativen: Greenlight

Gründe für den Wechsel zu Qualio: Greenlight also seemed like a great product but the implementation speed and ease of Qualio was out deciding factor.

Antwort von Qualio

vor 6 Monaten

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.

Barbara
Sr Q Mgr in USA
Medizinische Geräte, 51-200 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Qualio as a regulated quality management system

5,0 vor 6 Monaten

Kommentare: 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

Vorteile:

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.

Nachteile:

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

Antwort von Qualio

vor 6 Monaten

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.

Irma
Director of Quality Assurance in USA
Biotechnologie, 11-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Needs basic improvements

3,0 vor 6 Monaten

Kommentare: Document Management works well

Vorteile:

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

Nachteile:

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.

In Betracht gezogene Alternativen: Document Control

Gründe für den Wechsel zu Qualio: Price

Antwort von Qualio

vor 6 Monaten

We appreciate your feedback regarding change control and periodic review reports and have provided this to our product team.

Santino
Student in Jamaika
Bildungsmanagement, 501-1.000 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio Review

4,0 vor 2 Monaten

Vorteile:

Qualio is an awesome document manager especially for persons looking to transition from paper to electronic record keeping. This platform has an excellent user interface that is easy to navigate with practice. Excellent customer support from the team made implementation easier.

Nachteile:

No issues have been experienced with the platform so far.

jared
Director, Strategic Projects in USA
Medizinische Geräte, 501-1.000 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Excellent people supporting an excellent product

5,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Antwort von Qualio

vor 6 Monaten

Hi Jared, thank you for your fantastic review and we're so happy to hear that Qualio has made life easier for your Quality team! We'd love to get more of your thoughts on scaling usage of Qualio outside of Medical Device and your CS contact can answer any questions you might have on this.

Cynthia
Vice President, Regulatory Affairs in USA
Medizinische Geräte, 11-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Qualio Review

5,0 vor 6 Monaten

Kommentare: I am very satisfied with Qualio.

Vorteile:

Ease of use, search feature, and the dashboards for overdue training, deviations.

Nachteile:

Quality events feature is a little confusing.

In Betracht gezogene Alternativen: Veeva QualityOne EQMS

Gründe für den Wechsel zu Qualio: Cost and ease of use.

Antwort von Qualio

vor 6 Monaten

Hi Cynthia, we're happy to hear that so many of Qualio's features are enabling your QMS processes. If you'd like to provide any additional details on improvements to our Events feature, please feel free to reach out to me directly.

John
John
Quality Manager in USA
Verifizierter Nutzer auf LinkedIn
Medizinische Geräte, 51-200 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Qualio helps lead the way through our MDSAP recertification audit.

4,0 vor 6 Monaten

Kommentare: 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!

Vorteile:

Software is easy to use and navigate, and to train others to use at different levels. Record and report output is quick and organized.

Nachteile:

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!

Antwort von Qualio

vor 6 Monaten

Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well!

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 6 Monaten

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 6 Monaten

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 6 Monaten

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 6 Monaten

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.

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 6 Monaten

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!

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 6 Monaten

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 6 Monaten

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.

Rob
Sr Director of IT and Security Officer in USA
Gesundheit, Wellness & Fitness, 201-500 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

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

5,0 vor 4 Jahren

Vorteile:

- 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

Nachteile:

- 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.

Antwort von Qualio

vor 3 Jahren

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!

Verifizierter Rezensent
Senior Quality Assurance Manager in USA
Verifizierter Nutzer auf LinkedIn
Biotechnologie, 11-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

The perfect system for startups and young organizations

5,0 vor 4 Jahren

Vorteile:

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.

Nachteile:

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!

Antwort von Qualio

vor 3 Jahren

An intuitive and simple interface is at the core of Qualio's software, so it's fantastic that you've really benefited from this. Thank you for your feedback on our data reporting capabilities too we are looking to rollout improvements to this functionality soon.

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 6 Monaten

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 6 Monaten

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.

Jonas
Quality Manager in Norwegen
Informationstechnologie & -dienste, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Perfect for Medical Device startups

5,0 vor 6 Jahren

Kommentare: 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.

Vorteile:

Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation

Nachteile:

Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.

Antwort von Qualio

vor 3 Jahren

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.

Karthi
Head of Manufacturing in Australien
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

A true QMS for the Cloud

4,0 vor 6 Monaten

Vorteile:

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.

Nachteile:

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.

Antwort von Qualio

vor 6 Monaten

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.

Mallory
Clinical Trial Associate in USA
Forschung, 51-200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

User friendly platform

5,0 vor 2 Jahren

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

Vorteile:

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!

Nachteile:

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.

Antwort von Qualio

vor 2 Jahren

Thank you, Mallory! We're so glad you can get to what you need in Qualio. Excellent feedback too! We'll get that shared with the product team for review.

Daryl
Director in UK
Groߟhandel, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Qualio User Review

4,0 vor 6 Monaten

Kommentare: Has given our QMS a firm foundation

Vorteile:

After the initial 'new interface' confusion which is normal for a new application, the product is actually very easy to use

Nachteile:

Can't use existing documents as a template for new documents

Antwort von Qualio

vor 6 Monaten

Thank you for your input, Daryl! We've provided your feedback to our product team.

Kristi
Associate Director of Quality in USA
Medizinische Geräte, 11-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Good for start ups

4,0 vor 6 Monaten

Kommentare: 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.

Vorteile:

I liked the ability to build and edit the event flows (NCR, CAPA, etc).

Nachteile:

Redline feature is not great right now.

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 6 Monaten

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.

Richard
Director, Data Analytics in Niederlande
Forschung, 201-500 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Qualio review by CRO director

4,0 vor 6 Monaten

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

Vorteile:

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

Nachteile:

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

Antwort von Qualio

vor 6 Monaten

Thanks for your review, Richard! We appreciate and have submitted your feedback to our product team.

Stephen
Senior Security Manager in USA
Gesundheit, Wellness & Fitness, 11-50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio - Quality Control, Document Management and Traceability

4,0 vor 6 Monaten

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

Vorteile:

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.

Nachteile:

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.

Antwort von Qualio

vor 6 Monaten

Hi Stephen, we are always looking to improve our product and appreciate your feedback.

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 6 Monaten

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 6 Monaten

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

Kristinn
Regulatory and Compliance Officer in Island
Medizinische Geräte, 51-200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Focus on being a QMS

4,0 vor 6 Monaten

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

Vorteile:

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

Nachteile:

It’s a little difficult to navigate at first

In Betracht gezogene Alternativen: Greenlight Guru und MasterControl Quality Excellence

Gründe für den Wechsel zu Qualio: More focused on the needs we had.

Antwort von Qualio

vor 6 Monaten

Thank you Kristinn, we're happy to hear you've had a positive experience with the Qualio team.

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 6 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 3 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.