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Sobre Qualio

Sistema de gestão da qualidade (QMS, na sigla em inglês) para dispositivos médicos, farmacêuticos e biotecnológicos. Conformidade total com a FDA/ISO/GxP. Controle de documentos cinco vezes mais rápido, treinamento, CAPA, NCRs, auditorias e muito mais.

Saiba mais sobre o Qualio

Vantagens:

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

Desvantagens:

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

Notas do Qualio

Pontuação média

Praticidade
4,5
Atendimento ao cliente
4,7
Recursos
4,3
Relação qualidade/preço
4,5

Probabilidade de recomendação

8,5/10

O Qualio tem uma classificação geral de 4,5 em 5 estrelas com base em 124 avaliações de usuários no Capterra.

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Filtrar avaliações (124)

Mickey
Mickey
Controller, EUA
Usuário do LinkedIn Verificado
Biotecnologia, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Great Software

5,0 há 2 anos

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

Vantagens:

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

Desvantagens:

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

Resposta do Qualio

há 2 anos

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, EUA
Usuário do LinkedIn Verificado
Fabricação de alimentos, 201–500 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Alternativas consideradas anteriormente:

User friendly, sleek eQMS software

4,0 há 11 meses

Comentários: 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.

Vantagens:

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.

Desvantagens:

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.

Ben
Manager of Islet Product Manufacturing, EUA
Biotecnologia, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Good but could be great

4,0 há 2 meses Novo

Comentários: I'd rate Qualio an B+ to A-. It would be a perfect A if the word processor built into the program was a little more user friendly when it comes to formatting things like Worksheets.

Vantagens:

Super easy to use (with one exception which I'll describe below). Great at reminding me of tasks that need completion. Easy for people to pick up with a little instruction. Onboarding was easy.

Desvantagens:

The word processing portion is often frustrating. It is designed for ease of use, but coming from Microsoft word, Qualio's word processing unit is lacking in a few things. First, the toolbar is minimal. I'd like more tools when I'm formatting. Second, the formatting in the online word processing is atrocious. I have to constantly export the documents to ensure the worksheets I make aren't broken up between pages (I suggest some sort of preview of page alignment, so that I don't constantly have to DL a PDF when I'm formatting Worksheets).

Justin
Sr Director PD, EUA
Aparelhos médicos, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Needs to have watermarks

3,0 há 2 meses

Vantagens:

Simple tool. Not a lot of complexity,

Desvantagens:

limited ability to export content.

Melissa
QA RA, França
Aparelhos médicos, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Decent QMS support system

4,0 há 2 meses

Comentários: Overall I'm satisfied with the product but I don't love it enough to recommend strongly. It's getting the job done, but I feel like that's with a number of (minor) workarounds. However, based on the experience in the last 9 months, I do expect it to continue to improve.

Vantagens:

I appreciate that all of the main functionalities (document management, CAPA, Complaint, Supplier Management, etc.) are available in the system. The referencing between events and between documents works very well. It's also reasonably easy to customize templates and certain workflows. I also appreciate that they are regularly improving the system and that there is good attention on providing supporting validation documentation.

Desvantagens:

There are certain features that should have more control such as the implementation of new Event templates. This can be a major change to the quality system and essentially there is no workflow around it. Anyone with the access level can make the change with no review or approval. The formatting of documents is sometimes also very inconsistent and difficult to use. The final complaint is the inability to migrate from the sandbox to the production instance.

Brian
Quality Manager, EUA
Aparelhos médicos, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Qualio disappointing

4,0 há 2 meses Novo

Comentários: Poor - I came in late (hardly anything was done) with the implementation and just wasn't aware of the capabilities of Qualio, and Qualio was backing out of the on-boarding process. I don't believe Qualio provided me with a good understanding of the capabilities of the system and how best to set it up.

Vantagens:

I do like the Document Lifecycle management and the control of documents. Need the ability to have separate libraries, (i.e for Technical Documents) and not by tag!

Desvantagens:

Cost....Not much of a value when compared to manual systems Most everything in Qualio requires the same effort as a manual system (document control/life cycle is the exception, although some software offers version control!) I also resent the price increase applied this past year and the inability of Qualio to negotiate or justify the increase. We are actively evaluating other suppliers.

Nesh
software engineer, EUA
Aparelhos médicos, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio review

4,0 há 2 meses

Vantagens:

I like that it is easy to use. Has good version control. It facilitates good review process

Desvantagens:

Qualio does not keep resolved comments. When someone completes review and click ‘Mark as reviewed’ in Qualio, no email notification is received. For an existing table, adding multiple rows at a time is not possible. Only one row can be added. Unable to copy the contents across multiple rows. There is no functionality to replace one character string with another. Doesn’t notify if a particular reviewer completed review. Doesn’t allow comments by a particular reviewer if that reviewer completed review. Not possible to filter for comments from a particular reviewer. Can not add multiple rows in table. All documents in all states should be visible to all users. Can not delete comments.

Hanifa
Quality Assurance Officer, Quênia
Indústria farmacêutica, 51–200 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

The solution to management of QMS activities and Events

5,0 mês passado Novo

Comentários: It has been an interesting learning experience and the solution to the tedious manual QMS.
Work is simplified and distributed evenly.
Is a fairly lean system.

Vantagens:

Qualio has been improving every quarter to satisfy customer needs by incorporating suggestions for improvements made by customers and advancement of the feature available for use as per the current GMP regulations.

Desvantagens:

One has to adapt very fast with the changes to enjoy the benefits. So much good not to miss out on the advantages.

Joel
Quality Manager, EUA
Alimentação e bebidas, 201–500 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Start up company with Qualio

5,0 há 2 meses

Comentários: Overall very happy, but it is my understand there may be some very significant price increases coming our way which could cause us to look at alternate systems

Vantagens:

*Customer Service *Ease of initial installation *Sandbox feature

Desvantagens:

*Suppliers module *Improvement suggestions not always acted up efficiently

Todd
VP of Quality Assurance, EUA
Semicondutores, 11–50 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Qualio Implementation, QMS Creation, and ISO Audit.

5,0 há 2 meses

Comentários: Great experience, allowed me implement a company wide QMS, passing ISO registration audits both times.

Vantagens:

Simple but complex at the same time, great features.

Desvantagens:

Docuemnt formatting could be improve, but very good currently.

Jonathan
Quality Assurance Manager, EUA
Biotecnologia, 11–50 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Quality is in it's name and it delivers!

5,0 há 2 meses

Comentários: I, and the company, have had a good experience with Qualio. Though there have been a few troubled spots we have always been reassured and received the improvements that have fixed issues. We are reassured that the Qualio team is working hard to give its clients the best quality management experience possible.

Vantagens:

Qualio is a platform that we've seen grow over the years. They are a team that strives to deliver a product that meets the needs of its clients and is continually improving upon past versions to deliver a product and experience that is unobtrusive to workflow at a reasonable cost. Their service team ensures you have what you need, and diligently works to implement needed changes if a feature is not available. It's clean and navigable. I highly recommend it for smaller businesses or startups.

Desvantagens:

We have waited on occasion past a couple of feature releases for much-needed editor and supplier management changes. The review process and audit trail are good, but change control (requesting approval to create drafts, risk assessment features, and tracking changes between versions) are lacking. Sometimes it shows large chunks of text as removed and replaced when only a few changes were made. Sometimes it shows all it's changes in rich text code which is unreadable for most.

Barbara
Sr Q Mgr, EUA
Aparelhos médicos, 51–200 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Qualio as a regulated quality management system

5,0 há 2 anos

Comentários: 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

Vantagens:

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.

Desvantagens:

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

Resposta do Qualio

há 2 anos

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.

Jigar
Quality Auditor, Índia
Serviços e tecnologia da informação, 201–500 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio Review

5,0 há 11 meses

Comentários: Yeah, it is good to use, good to show someone your documentation and completes the process flow with respect to the features and configurations.

Vantagens:

It is the best document management system which consist of whatever things you required with respect to ISO standards and as well as the company standards. It can be configurable. Best interface, controlled documentation, easy to use and to show external parties.

Desvantagens:

There are no such thing that i dislike, but some sort of feature incorporation while releasing a patch or full release can be taken as feedback from current users so that the new feature or full release can contains the things which are mostly required by the end users.

Neil
Sr. Director of Quality, EUA
Biotecnologia, 51–200 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio is a great flexible QMS tool for small companies

3,0 há 10 meses

Comentários: 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.

Vantagens:

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.

Desvantagens:

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.

Rob
Sr Director of IT and Security Officer, EUA
Saúde, bem-estar e condicionamento físico, 201–500 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

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

5,0 há 6 anos

Vantagens:

- 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

Desvantagens:

- 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.

Resposta do Qualio

há 5 anos

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!

Thomas
QA Engineer, EUA
Biotecnologia, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Qualio user

4,0 há 2 anos

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

Vantagens:

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.

Desvantagens:

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.

Resposta do Qualio

há 2 anos

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.

Claire
QARA Engineer, Reino Unido
Aparelhos médicos, 51–200 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio has potential

3,0 há 2 meses

Comentários: Overall I think Qualio has a lot of potential. It has a lot of functions which just need slight improvements before they can be fully effective.

Vantagens:

I like the version control of documents and that minor changes can be made without sending the document for re-training. Customer service is exceptional with issue and queries being addressed as soon as possible.

Desvantagens:

The 'compare against' function is not very useful as often it highlights entire sections of text instead of the specific changes. It also shows code when changes are made to tables or images. The inability to revision control templates directly. If templates update, changes within sections have to be applied manually to documents in draft.

Karthi
Head of Manufacturing, Austrália
Aparelhos médicos, 2–10 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

A true QMS for the Cloud

4,0 há 2 anos

Vantagens:

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.

Desvantagens:

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.

Resposta do Qualio

há 2 anos

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.

Jonas
Quality Manager, Noruega
Serviços e tecnologia da informação, 2–10 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Perfect for Medical Device startups

5,0 há 8 anos

Comentários: 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.

Vantagens:

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

Desvantagens:

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

Resposta do Qualio

há 5 anos

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.

Bastien
Production lead, Canadá
Aparelhos médicos, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio for the win !

5,0 há 2 anos

Comentários: 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.

Vantagens:

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

Desvantagens:

- 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.

Resposta do Qualio

há 2 anos

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, EUA
Pesquisa, 501–1.000 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Great software for Required Training

5,0 há 2 anos

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

Vantagens:

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.

Desvantagens:

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

Richard
Director, Data Analytics, Países Baixos
Pesquisa, 201–500 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Qualio review by CRO director

4,0 há 2 anos

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

Vantagens:

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

Desvantagens:

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

Resposta do Qualio

há 2 anos

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

jocelyn
Materials Manager, EUA
Aparelhos médicos, 51–200 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Not efficient to run report

4,0 há 10 meses

Comentários: Fair

Vantagens:

It documented all the changes and updates.

Desvantagens:

Can't run report or easy access to report even though the data are in Qualio. Will be great if user can run a table report and export the information into excel sheet.

Caldin
Quality control manager, Quênia
Indústria farmacêutica, 51–200 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Best eQMS

5,0 há 11 meses

Comentários: It's the best eQMS I have used so far

Vantagens:

The access controls , events segmentation and the audit trail feature.

Desvantagens:

It could be better for each lauch train to have an independent industry centric webinar for trainings

Jessica
Chief Commerical Officer, EUA
Aparelhos médicos, 2–10 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Beware, Qualio is not a Turnkey Solution

2,0 há 11 meses

Comentários: The drafted documents and form templates make starting easier, but they must be tailored to the company's needs, which requires a quality person. Plus, just having the documents does not create a quality system. Please don't be fooled by the pitch that Qualio is a turnkey solution. Be aware that Qualio will not let you out of your contracted commitment.

Desvantagens:

It is not easy to create QMS with the documents alone.