Sierra QMS

RATING:

4.9

(13)

About Sierra QMS

Sierra QMS is a highly configurable and customizable quality management system (QMS) built specifically for healthcare and life sciences industry. It leverages agile technology and automation capabilities to ease the burdens of regulatory compliance, lower compliance costs, and accelerate time to market. Due to its customizable nature, Sierra QMS is designed for any business size at any life cycle stage. The system supports you with managing your documents, trainings, non-conformances, CAPAs, and audit events to show compliance with GxP validation and verification processes and 21 CFR Part 11 requirements. Sierra QMS also automates the publishing of validation artifacts (such as user requirements, functional specifications, code review reports, etc.) from other applica...

Sierra QMS Pricing

Pricing based on User Tier. We offer Startup pricing and can be flexible. Email hello@sierralabs.com if you'd like a quote! Free trial available, no credit card required.

Free trial: 

Available

Free version: 

Not Available

Publish documents for your audits, inspections, and submissions in a matter of seconds. Sierra QMS allows you to publish information from your QMS into templatized documents to share with regulatory bodies.

Sierra QMS Reviews

Overall Rating

4.9

Ratings Breakdown

Secondary Ratings

Ease-of-use

5

Customer Support

5

Value for money

5

Functionality

5

Most Helpful Reviews for Sierra QMS

1 - 5 of 13 Reviews

Ashoi

Computer Software, 11-50 employees

Used weekly for less than 12 months

Review Source: Capterra

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed March 2022

Highly capable Quality Management System

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.

Reason for choosing Sierra QMS

Cheaper and easier to use, while supporting greater integration options with other software tools

Amber

Medical Devices, 2-10 employees

Used weekly for less than 12 months

Review Source: Capterra

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed May 2022

New to QMS

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.

Reason for choosing Sierra QMS

Greenlight Guru was too pushy and it was overpriced for what we needed - a lot of add on costs.

Ryan

Computer Software, 11-50 employees

Review Source: Capterra

OVERALL RATING:

4

EASE OF USE

5

VALUE FOR MONEY

4

CUSTOMER SUPPORT

5

FUNCTIONALITY

4

Reviewed March 2022

Sierra QMS

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.

Michael

Health, Wellness and Fitness, 2-10 employees

Used weekly for less than 12 months

Review Source: Capterra

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

5

Reviewed May 2022

Opio QMS review

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.

Reason for choosing Sierra QMS

Simply to use at a better cost point with available help to build our system from scratch.

Carrie

Medical Devices, 11-50 employees

Used daily for less than 6 months

Review Source: Capterra

OVERALL RATING:

5

EASE OF USE

5

VALUE FOR MONEY

5

CUSTOMER SUPPORT

5

FUNCTIONALITY

4

Reviewed March 2022

Sierra QMS for Startup Medical Device Company

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.

Reason for choosing Sierra QMS

Sierra QMS was more configurable, more affordable, and had a more intuitive user interface.