Sierra QMS

4.9 (13)
Automate Regulatory Compliance and Speed Your Innovations!

Overall rating

4.9 /5
(13)
Value for Money
4.9/5
Features
4.8/5
Ease of Use
5/5
Customer Support Software
5/5

100%
recommended this app
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13 Reviews

Carrie
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 1-5 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Sierra QMS for Startup Medical Device Company

Reviewed on 3/25/2022

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.

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.

Emily
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 11-50 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

QMS for Healthcare Review

Reviewed on 5/19/2022

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.

Pros

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.

Cons

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.

Ashoi
Overall rating
  • Industry: Computer Software
  • Company size: 11-50 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Highly capable Quality Management System

Reviewed on 3/21/2022

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.

Alternatives Considered

Greenlight Guru and Qualio

Reasons for Switching to Sierra QMS

Cheaper and easier to use, while supporting greater integration options with other software tools
Amber
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

New to QMS

Reviewed on 5/20/2022

Great company, excellent expertise and would recommend 100%.

Pros

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.

Cons

That the user needs cannot be rearranged and that they are listed in a chronological order.

Alternatives Considered

Greenlight Guru and Qualio

Reasons for Switching to Sierra QMS

Greenlight Guru was too pushy and it was overpriced for what we needed - a lot of add on costs.
Michael
Overall rating
  • Industry: Health, Wellness & Fitness
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Opio QMS review

Reviewed on 5/20/2022

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.

Pros

The software ease of use and intuitive layout made sense.

Cons

Since we were building our QMS from scratch, perhaps access to other example QMS documents/layouts would be helpful.

Alternatives Considered

Greenlight Guru

Reasons for Switching to Sierra QMS

Simply to use at a better cost point with available help to build our system from scratch.
Eric
Overall rating
  • Industry: Information Technology & Services
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 9.0 /10

Most straightforward & simple QMS I've Used

Reviewed on 3/16/2022

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.

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.

Kwame
Overall rating
  • Industry: Medical Devices
  • Company size: Self Employed
  • Used Weekly for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Sierra Labs Ease of Use

Reviewed on 3/23/2022

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

Arin
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Weekly for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Great QMS!

Reviewed on 4/4/2022

Sierra Labs has been a "breath of fresh air". Having worked with various QMS, Sierra Labs is the easiest to use, maintain, and validate. Highly recommend for high-compliance industries!

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.

Ian
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Great Product for a Great Price

Reviewed on 4/10/2022

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.

Ryan
Overall rating
  • Industry: Computer Software
  • Company size: 11-50 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Flexible, customizable and easy to use QMS

Reviewed on 3/17/2022

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.

Ryan
Overall rating
  • Industry: Computer Software
  • Company size: 11-50 Employees
  • Used Weekly for Free Trial
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

Sierra QMS

Reviewed on 3/21/2022

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.

Nikita
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 51-200 Employees
  • Used Weekly for 1-5 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Sierra QMS

Reviewed on 3/12/2022

Overall, I had a great experience and would recommend this product for startups and established businesses. It is one of the best ones out there.

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.

Evan
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Monthly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Sierra QMS offers simple workflows.

Reviewed on 3/23/2022

So far, we have enjoyed working with Sierra to deploy quality management systems in medical device companies--the support and knowledge that come with Sierra's product makes it easy.

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.