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aligned elements
Was ist aligned elements?
Wird dein Team von Dokumentationsarbeit ausgebremst, wenn es eigentlich modernste medizinische Geräte entwickeln sollte?
Dann bist du nicht allein.
Medizingeräteunternehmen geben an, dass bis zu 30 % des gesamten Entwicklungsaufwands für Dokumentationsarbeiten verwendet wird.
Aligned Elements ist das Medical Device ALM, mit dessen Hilfe du die Design-Control-Elemente deiner Design-History-Datei erstellen, verwalten und nachverfolgen kannst. Indem du weniger Zeit für die regelkonforme Dokumentation aufwendest, kannst du wertvolle Ressourcen für Innovationen freisetzen.
Wer verwendet aligned elements?
Die Kunden arbeiten in der Medizintechnikbranche und werden durch Normen wie die FDA-QSR-Vorschriften in den USA oder durch die Richtlinien für medizinische Geräte/In-Vitro-Diagnostika-Richtlinien (IVD-D) in Europa reguliert.
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aligned elements
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Bewertungen über aligned elements
In Betracht gezogene Alternativen:
Aligned; a very easy to use and useful tool for requirements management and risk management
Kommentare: We use Aligned for both risk management (dFMEA 60812 and risk analysis 14971) and requirements management. It is a no nonsense tool, with a good support team, customizable and easy to use.
Vorteile:
Easy requirement tracing, good trace table creation possibility, quick and personal support from Aligned when you have a problem, possibility to get templates from Aligned and/or create/adapt them yourself (if needed with their help via a video chat). I really like the personal support and the ease of use and tweakability.
Nachteile:
If you encounter an issue they are very willing to help. They can have a look with you really fast and if the problem requires an Aligned issue, they really want to improve their tool.
Antwort von Aligned
letztes Jahr
Thank you for taking the time to provide a very in-depth review!
A great tool that makes managing requirements easier
Kommentare: Aligned Elements is so helpful to us in enabling containment of the design and development process. The team @ Aligned are also incredibly receptive to our requests for customisation, and also always quick to act whenever we have issues or bugs.
Vorteile:
I really like the organisation which Aligned Elements provides. The ability to link together all items from your business needs and user needs, all the way through the design & development process, including your hazard analysis, verification & validation, will really help when it comes to performing a regulatory submission. With all of the key information being traced, change controlled, and managed in the same space, it is easy to follow the design process from start to finish.
Nachteile:
I feel there is definitely room to improve in terms of automating some tasks. It would be helpful to have the ability to set up reminder emails with a frequency for tasks which require completion. When adding tables within areas like a Verification test case, having the ability to set the width of columns would be helpful, as sometimes we have found that the visual aspects of a page can get a bit unwieldy, and side scrolling of a page then becomes necessary.
In Betracht gezogene Alternativen:
AE covers 80% of the needs
Kommentare: The product helps a lot to better adhere to processes. Secondly, missing items / traces / reviews are identified with 1 click. It improves efficiency during the life cycle mgmt of a product compared to manual paper work. Even if not used every day, it is intuitive to use.
Vorteile:
Easy to use. Great user support. Easy configurable for client's needs. Big plus: risk management included compared to other tools. Thus, traceability is easy among the artifacts.
Nachteile:
Sometimes, 2 AE windows next to each other would be useful to work efficiently -> work around with Word export. Need to log off / on again sometimes due to bugs.
Good tool for traceability but good bit more user friendly
Kommentare: It took me a long time to feel comfortable with the software but now that I know how to use it, I like it. However, until the complete development team is not using it in their daily work, we will not use all the functionalities of the software such collaboration or prioritization.
Vorteile:
I like that the structure of our documentation is directly reflected inside left menu and that this can be customized depending on processes the project needs to follow. This is helping to work according to our processes.
Nachteile:
Not so user friendly even if this was improved a lot the last 2 years. It is hard to remember how to use the software when it is only for sporadic use, a bit more guidance from the software would be helpful.
In Betracht gezogene Alternativen:
Stilla Review
Kommentare: Document generation is sooo cool !
Vorteile:
The Support Team : they are doing a GREAT job !
Nachteile:
Queries should be more flexible, more powerful. Same for widgets. Widgets should be able to display the results of complex queries.The User Interface is difficult to grasp at the beginning.Need at least 1 to 2 weeks to understand how it is organized.
Antwort von Aligned
letztes Jahr
Thank you for your review Nicolas!
