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Sierra QMS
Description de Sierra QMS
Sierra QMS est un QMS (Quality Management System) hautement configurable et personnalisable qui exploite des fonctionnalités d'automatisation et technologiques agiles pour s'alléger des contraintes de la conformité réglementaire.
La solution simplifie la mise en conformité réglementaire et vous permet de vous concentrer davantage sur vos innovations, tout en vous assurant une commercialisation plus rapide et à moindre coût.
Un QMS est conçu pour s'adapter à vos pratiques organisationnelles en vigueur et non l'inverse. C'est la raison pour laquelle Sierra QMS s'intègre aux outils que vous utilisez et aimez déjà.
Qui utilise Sierra QMS ?
Les entreprises d'appareils médicaux, de SaMD (Software as a Medical Device), de biotechnologies, pharmaceutiques, de santé numérique et de recherche clinique en quête d'une approche Agile et efficace de la qualité et de la conformité.
Sierra QMS ne vous convainc pas tout à fait ?
Comparer avec une alternative populaire
Sierra QMS
Avis sur Sierra QMS
Alternatives envisagées précédemment :
Highly capable Quality Management System
Avantages :
The QMS is very easy to use and navigate. The highly-configurable options allow the QMS administrator to create complex workflows with automation rules to handle the organization's business processes. From an end-user perspective, it's really easy to follow along the workflows when completing change orders or CAPAs.
Inconvénients :
The QMS could use some more robust data querying and reporting features.
Alternatives envisagées précédemment :
New to QMS
Commentaires : Great company, excellent expertise and would recommend 100%.
Avantages :
We reviewed 7 QMS products and Sierra QMS seemed to be the most intuitive. It also had better functionality for software heavy products for integration to show traceability - many other QMS products don't have this.
Inconvénients :
That the user needs cannot be rearranged and that they are listed in a chronological order.
Sierra QMS
Avantages :
I found the training programs very helpful, made it very simple to setup new training plans and to assign the teams that would be participating, as well as monitor what trainings our teams had finished already.
Inconvénients :
I thought the help section could be improved, would be nice to possible see a list of common questions to improve the initial learning curve of the product.
Alternatives envisagées précédemment :
Opio QMS review
Commentaires : It's been a great overall experience with Sierra as we've changed direction a couple times now and they are adaptive and understanding of our needs as we narrow in on our path to market.
Avantages :
The software ease of use and intuitive layout made sense.
Inconvénients :
Since we were building our QMS from scratch, perhaps access to other example QMS documents/layouts would be helpful.
Sierra QMS for Startup Medical Device Company
Commentaires : Sierra is so much more than a document retention system. There is a lot of built in functionality. We can automate the Design Trace Matrix (i.e. DI/DO/DVV), Hazard Trace Matrix, and Tracking of Equipment PM/CAL and input CAPAs, Complaints, Nonconformances, etc. It is great how you can reference items to other items within the QMS.
Avantages :
Sierra QMS is Highly configurable. We are able to customize it to our needs. If it is not built in, it can be built. Sierra developed a Risk Analysis module for us so we can track risks for CAPAs, Complaints, non conformances, etc. With their platform, new modules are pretty quick to deploy. You can essentially automate any kind of form that you want. It has more functionality than the competitors. For example, there are built in Modules for Design and Hazard traceability. Imagine no more complicated spreadsheets to maintain!!! I like the Supplier Management module. You can email a link to a supplier and they can populate their supplier evaluation survey within Sierra QMS. I also like the CAPA module as you can customize the electronic forms and workflows. It is very easy to use as an admin and as an average user. It takes very little training for a new user to get started due to the intuitive UI. We found the pricing to be simple and competitive.
Inconvénients :
I wish I could export the raw data from the QMS so I can make ad hoc reports. I hear this is coming soon though. It would be nice if you could collaborate on documents undergoing a change order within the software.