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QT9 QMS
¿Qué es QT9 QMS?
Software de gestión de calidad simplificado. QT9 QMS es un destacado eQMS fácil de usar. Esta plataforma integral y basada en la nube ofrece escalabilidad ilimitada. Centraliza el control de documentos, aprueba CAPA y automatiza el cumplimiento con las normas de ISO y FDA. Registra fácilmente las aprobaciones de firmas electrónicas según FDA 21 CFR Parte 11. Obtén una trazabilidad completa Obtén analíticas en tiempo real. QT9 QMS incluye una plataforma totalmente validada que es ideal para empresas de los sectores de ciencias biológicas, farmacéuticas, dispositivos médicos y biotecnología. Se puede usar de inmediato. Ofrece prueba gratis.
¿Quién usa QT9 QMS?
Cualquier organización que deba supervisar el cumplimiento normativo (como ISO 9001, ISO 13485, AS9100, cumplimiento con FDA, etc.) o cualquier organización que busque gestionar su sistema de calidad sin papel con una interfaz fácil de usar.
¿Tienes dudas sobre QT9 QMS?
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QT9 QMS
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Opinones de QT9 QMS
Alternativas consideradas:
QT9 QMS: La mejor opción para la gestión de calidad en linea
Comentarios: En general, QT9 QMS es una herramienta sólida y completa para la gestión de calidad en línea, con muchas características avanzadas y una amplia gama de integraciones. Sin embargo, puede haber algunas limitaciones en cuanto al precio y la complejidad de configuración e implementación, y las integraciones pueden ser limitadas en comparación con otras herramientas de gestión de calidad en línea.
Puntos a favor:
Ofrece una amplia gama de características de gestión de calidad, como control de documentos, gestión de no conformidades, gestión de riesgos, y auditorías, la interfaz es fácil de usar y personalizable para adaptarse a las necesidades de la empresa, ofreciendo una amplia gama de características de informes y análisis, incluyendo paneles de control en tiempo real y gráficos personalizables.
Contras:
El precio puede ser alto en comparación con otras herramientas de gestión de calidad en línea, la configuración inicial y la implementación pueden ser complejas para algunos usuarios nuevos y las integraciones pueden ser limitadas en comparación con otras herramientas de gestión de calidad en línea.
Respuesta de QT9 Software
el año pasado
Miguel Angel - Thank you for the positive review. We are happy to hear you like QT9's wide range of features and ease of use. Please reach out to us if your team needs help with anything.
Muy buen sistema de calidad
Comentarios: Lo implementamos para poder tener todo automatizado, sin tener que recurrir al trabajo manual, ya que se hacía muy tedioso.Al final, el cambio ha sido muy positivo.
Puntos a favor:
Software con una muy buena facilidad de uso y buen servicio al cliente antes dudas y resolución de problemas.Programa muy intuitivo, fácil de navegar.Módulos muy bien diseñados.Información recogida muy práctica.
Contras:
De momento no hemos encontrado ningún incoveniente en la utilización del programa. Tampoco echamos nada en falta. La verdad que es un programa muy completo.
Respuesta de QT9 Software
hace 2 años
Thank you for the 5-Star Review! That is awesome to hear you find QT9 QMS very intuitive and that you have been able to automate processes. That is important to us. • It is always great to hear from happy customers.
Highly customizable and efficient eQMS
Comentarios: QT9 is a very solid and dense software that can be tailored to the needs of any business. User access and admin controls are very deep and easy to use. The module and workflows are plentiful, and while they can be intimidating to implement, once you dig in a really understand what the software features can do, the reward is high as the software is able to create and track so much.
Puntos a favor:
The ability to creature user defined fields that could be tailored specifically to the record of document that was being created in the system was extremely useful when transitioning from established Quality processes from our previous paper-based QMS to this electronic software.
Contras:
Implementation was a bit of a challenge. While we did have support from the developer and implementation team, the training seminars available were not nearly as helpful as simply diving into the sandbox environment and see what the system could actually do.
Respuesta de QT9 Software
el año pasado
Dexter - Thank you for the 5-Star review! We are happy to hear you have been able to tailor the platform to meet your needs. I will pass the feedback onto our team on the training seminars.
Alternativas consideradas:
QT9 QMS
Comentarios: We have observed several benefits from moving to QT9. It has allowed us to move from a paper based/manual QMS system to an electronic system and reduce our paper consumption and record storage. QT9 has streamlined our internal auditing process, preparation for regulatory audits, document control and approval, and organizational training. We have been able to reduce our active documents by 30% as unnecessary/redundant documents and procedures have been made more visible through the document review process. QT9 made it possible for our organization to effectively maintain and continue operating our QMS system without interruption during the global pandemic when limits were placed on gathering size. All of our records are now in one location and it has reduced the time that the organization and Quality unit spend in locating records.
Puntos a favor:
QT9 allowed us to replace our clunky paper based QMS and move completely to a streamlined, validated electronic platform. The ability to easily manage our document control, auditing, non-conformances, corrective actions, preventive actions, complaints, and calibrations in one location instead of having to spend time retrieving records from multiple locations. QT9 made it possible to maintain our organization's training needs during a global pandemic, when meeting face to face and in groups was restricted. QT9 made it possible to conduct remote training of our organization and evaluate effectiveness with a written test. It unknowingly prepared us to maintain all of our core Quality functions in the midst of a global pandemic without a mis-step. The report format (complaints, corrective/preventive actions, non-conformances, etc) look professional and they are able to quickly be downloaded and provided to either customers, suppliers, auditors, and internally. The consistency of the appearance of the screens in each module made training the organization to use very easy. It was easy to translate the learnings from one module to another. Implementation was similar as well. QT9 technical assistance in uploading of documents and gauges increased the speed in which were able to integrate it into our organization. The unlimited training was also critical especially for the calibration module as it took a bit longer for us to implement and understand how it functioned.
Contras:
One feature that would benefit from improving is the ability to create both corrective action and non-conformance records from a customer complaint. Currently, the software only allows the creation of one or the other, but not both. However, all records between complaints, corrective actions, and non-conformances are linked through a daisy chain scenario, but it can be awkward when retrieving records during an audit. The calibration module was the most difficult for us to implement as it operated a differently than the other modules. However, QT9 technical support assisted and provided us with all of the training that we requested without delay and worked with us to ensure that we implemented the module correctly for our organization's needs.
Respuesta de QT9 Software
hace 3 años
Jennifer - Thank you for the awesome and super detailed review! We really appreciate you taking the time to share your feedback. These are such great suggestions! We are sharing your feedback with our team.
Limited Flexability
Comentarios:
To be honest we do not use all the modules within QT9 but the ones we do use allow us to get by and pass our QMS audits, but for the power user like myself that wants to extract detailed performance data you’ll have to extract the data and pull it into excel and manipulate it to get metrics you need.
What you see is what you get, no customizing nothing. No overdue notifications or escalation process built in.
Puntos a favor:
Ease of rolling out the product. Built in forms are helpful for a beginner. There are some features if you dig into the settings that allow you minor custom uses. The Calibration and Prevenative Maintenance Modules are promising and somewhat helpful. The document control module has worked well for us.
Contras:
1. the biggest disappointment - No customability of modules and forms. Lots of tabs on the nonconforming product and corrective action forms and you cannot get rid of the tabs you do not need, You cannot even hide the tabs. Absolutely no customization to tailor to your organization. 2. No email reminders if you have overdue actions pending, you’ll have to look at the database daily. 3. No filtering of overdue items in perato analysis. You can filter: Open Items, Closed, Rejected, Submitted and deleted but nothing to tell you if an item is past due. No email notifications if an item goes past due. You can only disply the entire reports that are overdue. 4. Ad Hoc Reports are Lackluster for reporting performance data analysis (Perato Analysis, Bar Graphs, Line Graphs etc) Nothing here to help you determine how effective or ineffective your QMS is. 5. If you have more than one process approver (Risk, CA’s, NC’s etc) and one of them approves the action the other approvers cannot go back and make changes. Your locked out. I had myself and one other person approving a risk and the other approver approved the risk and I could not make any changes. I had to delete the entire risk action and start over. 6. Only exports to CSV files not Excel .xlsx extensions 7. Internal audit module - build a schedule only. No prefilled forms to use, no form development capabilities.
Respuesta de QT9 Software
hace 4 años
Hi Nacaro As soon as we saw the review, we had our team personally reach out to you. 1. Customizability: Unlimited custom fields are quick and easy to setup. Tabs cannot be hidden it is like an economy car vs a luxury car. The features are included. 2. Emails: QT9 automatically sends email reminders and overdue notifications to the responsible parties and/or administrators. 3. Filtering: Each individual user can customize their dashboard grids for each module to filter and display the content you want to see. It sounds like you have the "Status" column hidden. 4. Ad Hoc Reports: We include customizable filters for all canned reports and a customer report generator to create any report you could need for measurement. 5. Approvers: Simply change your settings to require 2 or more approvers. 6. Exports: We export to a universal CSV that can be easily be opened in Excel & other programs. 7. Audit Module: During implementation you build an electronic form and you attach related files.
