Sierra QMS

Pros: It's highly intuitive and helps us manage multiple portions of our business. As a SaMD company, we have to simultaneously keep track of design controls for our own records, but also for incoming team members. We also needed a product that could enable seamless review of updates to key process all while remaining in compliance with regulations.

Cons: I'd like a way to quickly download all of my process documents without having to go into each one to export. There may already be an easy way to do this that I haven't discovered yet.

Pros: The Software is extremely user friendly! The software does an amazing job of properly categorizing documents into applicable folders, making it easy to maintain a QMS and developing a product's DHF.

Cons: In comparison to the many other QMS' I have used, it has been great using Sierra Labs! Sierra Labs is very easy to use and even easier to train new colleagues to use.

Pros: 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.

Cons: 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.

Pros: The Sierra Labs environment is extremely intuitive and easy to use. The main data entry points are easy to find and the approval process is frictionless. I appreciate the real time updating and how tightly the tool allows a development team to map to ISO 13485 and the USFDA QSR. Some other aspects are the robust modules and dashboard that is easy to understand. I use the Sierra Labs QMS with my clients and plan to move them more in the future.

Cons: Email/Notification settings need to be configurable, but it is likely an easy update

Pros: We find Sierra's eQMS offering easy to use with our clients. It helps simplify workflows and quality engineering for medical device development.

Cons: We are uncertain about the ease of Part 11 validation.

Pros: 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.

Cons: 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.

Pros: 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.

Cons: The QMS could use some more robust data querying and reporting features.

Pros: Sierra QMS was flexible and highly customizable to fit our organizations needs. The UI was intuitive and coupled with the customizability, made it really easy to set up the QMS to fill our need. The Sierra team has been accessible for support which has made our implementation pretty seamless.

Cons: Sierra QMS has JIRA integration which is nice, there are some things where we have to go back and forth to update items. We've been told there are tighter integrations coming down the pipeline which is something we're really excited to try.

Pros: 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.

Cons: While a very strong entry in usability and design, there's always room for improvement to simplify the interface even further.

Pros: Workflow management was amazing and really easy to use UI is minimalistic, easy to use and at the same time feels complete Highly configurable and highly customizable to meet our processes

Cons: Configuring the QMS might take time if you do not have your policies and processes in place.