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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 4,6 em 5 estrelas com base em 123 avaliações de usuários no Capterra.

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Filtrar avaliações (123)

Atul Pratap
Atul Pratap
Sales And Marketing Specialist, Índia
Usuário do LinkedIn Verificado
Serviços e tecnologia da informação, 2–10 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Great eQMS software

5,0 há 2 anos

Comentários: 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.

Vantagens:

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.

Desvantagens:

It's challenging to create documents with Qualio. The formatting options could be improved. Some areas lack audit trails.

Neil
Head of QA/RA, Reino Unido
Aparelhos médicos, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Alternativas consideradas anteriormente:

Easy to use eQMS

5,0 ano passado

Comentários: 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

Vantagens:

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.

Desvantagens:

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

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 ano passado

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.

Savneet
Senior Quality Manager, EUA
Cosmético, 51–200 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Alternativas consideradas anteriormente:

Qualio set up and execution

5,0 ano passado

Comentários: Training has become much easier.

Vantagens:

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.

Desvantagens:

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.

Michele
Head of Regulatory & Quality Assurance, EUA
Aparelhos médicos, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Qualio is the Perfect eQMS - Simple and easy to use

4,0 ano passado

Comentários: 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.

Vantagens:

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.

Desvantagens:

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.

Michael
QA Director, EUA
Aparelhos médicos, 51–200 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Excellent solution for most quality management systems

5,0 ano passado

Vantagens:

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

Desvantagens:

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.

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 6 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.

John
John
Quality Manager, EUA
Usuário do LinkedIn Verificado
Aparelhos médicos, 51–200 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Qualio helps lead the way through our MDSAP recertification audit.

4,0 há 3 anos

Comentários: 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!

Vantagens:

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

Desvantagens:

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!

Resposta do Qualio

há 3 anos

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

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 há 5 meses

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.

chandini
Clinical data associate, Índia
Redação e edição de texto, 51–200 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

The best app for using your and reviewing your documents during your work.

5,0 há 6 meses

Comentários: I must say that its the best and Excellent everyone must OWN.

Vantagens:

The things i like the most is the interface that the Qualio provides which is very user friendly and easy to access and its development through year is incredible

Desvantagens:

I never saw anything that is troubling me in Qualio till date thats what made me impressed to use this daily at work.

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 ano passado

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.

Robert
Quality, EUA
Aparelhos médicos, 2–10 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

AMM Qualio Review

5,0 ano passado

Comentários: My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's.

Vantagens:

The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good.

Desvantagens:

I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.

Cynthia
Vice President, Regulatory Affairs, EUA
Aparelhos médicos, 11–50 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Alternativas consideradas anteriormente:

Qualio Review

5,0 há 3 anos

Comentários: I am very satisfied with Qualio.

Vantagens:

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

Desvantagens:

Quality events feature is a little confusing.

Resposta do Qualio

há 3 anos

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.

Stephanie
Quality Consulting Service, EUA
Aparelhos médicos, 2–10 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Qualio review

5,0 ano passado

Comentários: Implementing Qualio was easy, especially with the prewritten SOP's that could be adapted to the client needs. Qualio has been great for maintaining the quality system from Complaints, NCR's, CAPA's etc.

Vantagens:

Templates are helpful in guiding content creation across the organization. Events are great for managing approvals and maintaining evidence.

Desvantagens:

Training module doesn't provide a matrix type status, i.e. Documents versus all used and training requirements/status. Document identification did not allow for using predicate quality system document numbers.

Santino
Student, Jamaica
Gestão da educação, 501–1.000 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio Review

4,0 há 2 anos

Vantagens:

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.

Desvantagens:

No issues have been experienced with the platform so far.

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 3 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 3 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.

Kristi
Associate Director of Quality, EUA
Aparelhos médicos, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Good for start ups

4,0 há 3 anos

Comentários: 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.

Vantagens:

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

Desvantagens:

Redline feature is not great right now.

Sharon
HR Manager, Índia
Software, 51–200 funcionários
Usou o software para: Mais de dois anos
Fonte da avaliação

Great way to manage quality

5,0 ano passado

Vantagens:

Ease of use. Data storage. Ease of access

Desvantagens:

The document creation can be improved...

Stephen
Senior Security Manager, EUA
Saúde, bem-estar e condicionamento físico, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio - Quality Control, Document Management and Traceability

4,0 há 3 anos

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

Vantagens:

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.

Desvantagens:

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.

Resposta do Qualio

há 3 anos

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

Inge
CRA, Austrália
Pesquisa, 201–500 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Good software for keeping up to date with documentation

5,0 há 3 anos

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

Vantagens:

Training and searching, ease of finding and dowloading forms

Desvantagens:

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

Resposta do Qualio

há 3 anos

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

Bonnie
Quality Coordinator, EUA
Aparelhos médicos, 51–200 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

Qualio review

4,0 ano passado

Comentários: Our company loves that the training of our entire company Nationwide can train all at once without having to use a separate program

Vantagens:

Getting used to this system was a challenge. But once I learned to navigate it became quite easy. I love that this program works as Quality should and is always improving.

Desvantagens:

The fact that I can not archive and retrieve expired supplier documents

Dominika
Quality Representative, Polônia
Serviços e tecnologia da informação, 11–50 funcionários
Usou o software para: 6 a 12 meses
Fonte da avaliação

SdNcenter's review

5,0 há 6 meses

Comentários: Very professional and nice support with documents migration

Vantagens:

A system that is user friendly, easy to set-up and meets all requirements of ISO 13485

Desvantagens:

documents structure (hierarchy) not visible, impossible to copy events configuration from Sandbox into PROD

Sasiporn
Clinical Quality and Training Manager, Tailândia
Pesquisa, 11–50 funcionários
Usou o software para: Mais de um ano
Fonte da avaliação

Always support, continuous improvement and system is really easy to use

5,0 ano passado

Vantagens:

flexible, able to customize as per company's requirments.

Desvantagens:

document editable format is still have some limit function

Nihal
Nihal
Ceo, Quênia
Usuário do LinkedIn Verificado
Indústria farmacêutica, 201–500 funcionários
Usou o software para: 1 a 5 meses
Fonte da avaliação

Qualio Review

5,0 há 3 anos

Comentários: 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!

Vantagens:

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!

Desvantagens:

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