Sierra QMS 2026: Benefits, Features & Pricing

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Overview
Pricing and Plans
Features
Integrations
User Reviews

Overview

Sierra QMS

4.9

(13)

Pricing

Pricing available upon request

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 applications.

This platform is designed for biotech, digital health, pharmaceutical, and clinical research companies looking for an agile and efficient approach to quality and compliance. Create and track non-conformance and CAPAs with deep linking to related policies, audit events, training, and other related items. Utilize the systems clean and customized Dashboard to quickly monitor non-conformance and CAPA status. Appl...

y a 21 CFR Part 11 compliant electronic signature to all approved items and view the associated audit trail. Last but not least, Sierra QMS integrates with a plethora of 3rd party tools that you already use, such as Jira, Confluence, GitHub, and more! A QMS is meant to be built around your current organizational tools and practices, not the other way around. This is why Sierra QMS integrates with the tools you already use and love! Sierra Labs is focused on aligning engineering/IT teams with quality and compliance teams in FDA-regulated environments. The QMS, cloud validation, and automation products are designed to be easily adaptable in pre-existing workflows and assist teams in producing validation and verification artifacts needed in high-quality environments. For more information or to schedule a Free Demo, visit sierralabs.com today! Reap the Benefits from all of the following Sierra QMS Features: • Risk Management: Create and track non-conformance and CAPAs with deep linking to related policies, audit events, training, and other related items. Utilize the Dashboard to quickly monitor your non-conformance and CAPA status. • Document Publishing: 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. • Electronic Signatures: Apply a 21 CFR Part 11 compliant electronic signature to all approved items and view the associated audit trail. • Quality Roadmap: Strategically map out your quality journey, ensuring you reach each of your compliance milestones in your desired timeframes. Let’s take the stress out of Approvals, Certifications, and Audits with an actionable, step-by-step implementation plan. • Audit management: Effortlessly track your test findings, tasks, and action items to prepare for any and all future audits. Sierra QMS allows you to tackle audits in a systematic way with all of your data available at the click of a button. • Product Traceability: Maintain full traceability at each stage of production. Seamlessly track your product information and trace it throughout its entire life cycle to help you easily generate your regulatory documentation. • Training: Efficiently create training plans to ensure your team completes the necessary training requirements for compliance. Improve quality and compliance by guaranteeing your workforce has access to critical documentation, such as SOPs and Policies.

Sierra QMS Screenshots

Sierra QMS Pricing and Plans

Starting price: Connect with an advisor for pricing

Free Trial

Free Version

Basic

Pricing available upon request

No plan information available

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Sierra QMS Features

Popular features found in Quality Management
Change Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Management
Electronic Signature
Incident Management
Quality Control
Risk Management
Task Management
Training Management
More features of Sierra QMS
Access Controls/Permissions
Activity Dashboard
Activity Tracking
Alerts/Escalation
Alerts/Notifications
API
Approval Process Control
Archiving & Retention
Assessment Management
Audit Management
Audit Trail
Automated Scheduling
Collaboration Tools
Commenting/Notes
Communications Management
Compliance Management
Compliance Tracking
Customizable Reports
Customizable Templates
Dashboard
Data Import/Export
Data Visualization
Digital Signature
Document Automation
Document Check-in/Check-out
Document Coding & Control
Document Review
Document Storage
Document Templates
Drag & Drop
Email Alerts
Environmental Compliance
Equipment Management
FDA Compliance
File Management
For Engineering Documents
Forms Management
Full Text Search
HIPAA Compliant
Indexing
Inspection Management
Internal Controls Management
ISO Compliance
ISO Standards Management
IT Risk Management
Maintenance Management
Metadata Management
Mobile Access
Monitoring
Multiple Format Support
Nonconformance Tracking
Operational Risk Management
OSHA Compliance
Policy Management
Predictive Analytics
Real-Time Data
Real-Time Monitoring
Real-Time Notifications
Real-Time Reporting
Real-Time Updates
Reminders
Reporting & Statistics
Response Management
Revision History
Risk Analysis
Risk Assessment
Risk Reporting
Risk Scoring
Role-Based Permissions
Root Cause Analysis
Rules-Based Workflow
Sarbanes-Oxley Compliance
Search/Filter
Secure Data Storage
SSL Security
Status Tracking
Supplier Management
Supplier Quality Control
Surveys & Feedback
Tagging
Third-Party Integrations
Version Comparison
Version Control
Version Rollback
Workflow Management

Sierra QMS Integrations

Bitbucket

GitHub

Jira

TestRail

GitLab

Trello

See all 11 integrations

Sierra QMS User Reviews

Overall Rating

4.9

Ratings Breakdown

92%

Secondary Ratings

Ease of Use

5.0

Value for money

4.9

Customer support

5.0

Functionality

4.8

Have you used Sierra QMS and would like to share your experience with others?

Amber N.

Verified reviewer

Medical Devices

2-10 employees

Used weekly for less than 12 months

Reviewed May 2022

New to QMS

Great company, excellent expertise and would recommend 100%.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing Sierra QMS

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

Ashoi P.

Verified reviewer

Computer Software

11-50 employees

Used weekly for less than 12 months

Reviewed March 2022

Highly capable Quality Management System

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing Sierra QMS

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

Ryan E.

Verified reviewer

Computer Software

11-50 employees

Used weekly for free trial

Reviewed March 2022

Sierra QMS

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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 P.

Verified reviewer

Health, Wellness and Fitness

2-10 employees

Used weekly for less than 12 months

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing Sierra QMS

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

Carrie B.

Verified reviewer

Medical Devices

11-50 employees

Used daily for less than 6 months

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing Sierra QMS

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

Emily M.

Verified reviewer

Hospital & Health Care

11-50 employees

Used weekly for more than 2 years

Reviewed May 2022

QMS for Healthcare Review

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for switching to Sierra QMS

Sierra QMS has higher customization capabilities and is more user friendly.

Kwame U.

Verified reviewer

Medical Devices

Self-Employed

Used weekly for less than 2 years

Reviewed March 2022

Sierra Labs Ease of Use

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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

Eric R.

Verified reviewer

Information Technology and Services

2-10 employees

Used weekly for less than 12 months

Reviewed March 2022

Most straightforward & simple QMS I've Used

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.

Ratings Breakdown

Ease of use

Customer support

Functionality

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.

Ian M.

Verified reviewer

Medical Devices

2-10 employees

Used weekly for less than 12 months

Reviewed April 2022

Great Product for a Great Price

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Evan T.

Verified reviewer

Medical Devices

11-50 employees

Used monthly for less than 12 months

Reviewed March 2022

Sierra QMS offers simple workflows.

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

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