Was ist Sierra QMS?
Sierra QMS ist ein hochgradig konfigurierbares und anpassbares QMS (Qualitätsmanagementsystem), das agile Technologie und Automatisierungsfunktionen nutzt, um die Einhaltung gesetzlicher Vorschriften zu erleichtern.
Die Lösung macht die Einhaltung gesetzlicher Vorschriften einfach und ermöglicht es dir, dich mehr auf deine Innovationen zu konzentrieren und gleichzeitig sicherzustellen, dass du schneller und billiger auf den Markt kommst.
Ein QMS sollte um deine aktuellen betrieblichen Praktiken herum aufgebaut werden und nicht umgekehrt. Aus diesem Grund lässt sich Sierra QMS in die Tools integrieren, die du bereits verwendest und schätzt.
Wer verwendet Sierra QMS?
Unternehmen aus den Bereichen medizinische Geräte, SaMD (Software as a Medical Device), Biotechnologie, Pharmazeutik, Digital Health und klinische Forschung, die nach einem agilen und effizienten Ansatz für Qualität und Compliance suchen.
Wo kann Sierra QMS bereitgestellt werden?
Cloud, SaaS, webbasiert, Mac (Desktop), Windows (Desktop), Linux (Desktop), Windows (On-Premise), Linux (On-Premise), Chromebook (Desktop)
Sierra QMS – Videos und Bilder
Kosten ähnlicher Produkte wie Sierra QMS vergleichen
Sierra QMS Funktionen
- Alarmfunktion / Benachrichtigungen
- Archivierung & Aufbewahrung
- Compliance Management
- Corrective and Preventive Action (CAPA)
- Dokumentkodierung & -kontrolle
- Management by Exception
- Mobiler Zugriff
Alternativen für Sierra QMS
Bewertungen über Sierra QMS
In Betracht gezogene Alternativen:
New to QMS
Kommentare: Great company, excellent expertise and would recommend 100%.
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.
That the user needs cannot be rearranged and that they are listed in a chronological order.
Sierra QMS for Startup Medical Device Company
Kommentare: 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.
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.
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.
Most straightforward & simple QMS I've Used
Kommentare: The Sierra team was very helpful and communicative with the process of getting us set up and our environment configured. We had a consistent point of contact who was proactive at getting us set up as quickly as possible while explaining the best practices and tradeoffs along the way.
I appreciate how straightforward Sierra QMS is to use and understand. I have used other QMS solutions and I found them to be a labyrinth of business logic that was very difficult to navigate, configure, or learn how to use effectively. The document control and versioning is very simple to work with and reviewing documents in the browser is great which saves the effort of having to download for review.
While a very strong entry in usability and design, there's always room for improvement to simplify the interface even further.
In Betracht gezogene Alternativen:
Opio QMS review
Kommentare: 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.
The software ease of use and intuitive layout made sense.
Since we were building our QMS from scratch, perhaps access to other example QMS documents/layouts would be helpful.
QMS for Healthcare Review
Kommentare: Overall a great system! It has really helped to automate our compliance processes and decrease the amount of manual validation work for our teams. It has made it easier for our product and engineering teams to align with our QA/RA teams.
It's pretty customizable. The Sierra Labs team worked with us to create custom templates and workflows, and made the transition to a new system easy! The interface is user-friendly and the dashboard provides an up to date view of all of our tasks and assignments.
We originally wanted to integrate the QMS with a project management software other than Jira, but the QMS integrates so well with Jira that we ended up switching to that system. But more integration capabilities would be great for future production.