15 años ayudando a las empresas españolas
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Qualio
¿Qué es Qualio?
Plataforma de cumplimiento todo en uno para empresas de dispositivos médicos, farmacéuticas y biotecnología. Qualio te ayuda a lanzar productos en el mercado más rápido y lograr un cumplimiento al 100 % con FDA/ISO/GXP en las auditorías. Respaldado por equipos de control de calidad de todo el mundo para automatizar flujos de trabajo de cumplimiento críticos como el control de documentos, capacitación, NCR, CAPA, auditorías, proveedores, quejas y mucho más. ¡Inicia una conversación hoy mismo!
¿Quién usa Qualio?
Líderes de cumplimiento y calidad en empresas de Ciencias de la vida (biotecnología, dispositivos médicos, terapéutica, CxO) que se enfrentan a desafíos de cumplimiento y regulación (FDA, ISO, GXP)
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Opiniones de Qualio
Programa bastante útil
Comentarios: Gracias a este programa hemos incrementado la eficiencia en el área de calidad.
Puntos a favor:
Buena organización documental, buena estructura de organización, bastantes plantillas, registros, etc...
Puntos en contra:
Los comentarios que se realizan en los documentos, luego no están visibles para el personal que luego tiene que realizar la revisión.
Great eQMS software
Comentarios: 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.
Puntos a favor:
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.
Puntos en contra:
It's challenging to create documents with Qualio. The formatting options could be improved. Some areas lack audit trails.
Alternativas consideradas:
A Great Quality Management System to get you started.
Comentarios: 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.
Puntos a favor:
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.
Puntos en contra:
Qualio still have some sticking points with the document creation journey and while they are improving every day, they are still sorely lacking ease with the creation, reviewer and approval experience. Supplier event is also brand new and not quite the finished product yet. But its heading in the right direction.
Qualio is a great flexible QMS tool for small companies
Comentarios: 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.
Puntos a favor:
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.
Puntos en contra:
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.
Alternativas consideradas:
Customer Questionnaire
Comentarios: 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.
Puntos a favor:
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.
Puntos en contra:
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.
