# Sierra QMS Software Reviews, Demo & Pricing - 2026 > Review of Sierra QMS Software: system overview, features, price and cost information. Get free demos and compare to similar programs. Source: https://www.softwareadvice.com/manufacturing/sierra-qms-profile --- [Home](https://www.softwareadvice.com/) / [Quality Management Software](https://www.softwareadvice.com/manufacturing/quality-management-software-comparison/) / Sierra QMS Software Advice offers objective insights based on verified user reviews and independent product and market research. When our advisors match you to a software provider, we may earn a referral fee. Overview # Sierra QMS 2026: Benefits, Features & Pricing Wondering if Sierra QMS is right for your organization? Our Quality Management Software selection experts can help you in 15 minutes or less. On this page - Overview - User Interface - Popular Alternatives - Pricing and Plans - Features - Integrations - User Reviews ## Overview Sierra QMS 4.9 [(13)](https://www.softwareadvice.com/manufacturing/sierra-qms-profile/#reviews) 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. Wondering if Sierra QMS is right for your organization? Our Quality Management Software selection experts can help you in 15 minutes or less. ## Sierra QMS User Interface ## Popular Sierra QMS Alternatives Main Product Sierra QMS 4.9 [(13)](https://www.softwareadvice.com/manufacturing/sierra-qms-profile/#reviews) Ratings Breakdown - 5.0Ease of use - 4.92Value for money - 5.0Customer support - 4.77Functionality Pricing Available upon request Get Price Alternative Product [QT9 QMS](https://www.softwareadvice.com/manufacturing/qt9-profile/) 4.8 [(120)](https://www.softwareadvice.com/manufacturing/qt9-profile/reviews/) Ratings Breakdown - 4.66Ease of use - 4.74Value for money - 4.74Customer support - 4.58Functionality Pricing Available upon request Get Price Alternative Product [MasterControl Quality Excellence](https://www.softwareadvice.com/manufacturing/mastercontrol-profile/) 4.5 [(534)](https://www.softwareadvice.com/manufacturing/mastercontrol-profile/reviews/) Ratings Breakdown - 4.14Ease of use - 4.16Value for money - 4.48Customer support - 4.20Functionality Pricing Starting at $25000.00 per year Get Price Alternative Product [Qualityze Suite](https://www.softwareadvice.com/cmms/qualityze-profile/) 4.9 [(67)](https://www.softwareadvice.com/cmms/qualityze-profile/reviews/) Ratings Breakdown - 4.91Ease of use - 4.84Value for money - 4.95Customer support - 4.88Functionality Pricing Available upon request Get Price Alternative Product [Intellect QMS AI](https://www.softwareadvice.com/manufacturing/intellect-eqms-profile/) 4.6 [(84)](https://www.softwareadvice.com/manufacturing/intellect-eqms-profile/reviews/) Ratings Breakdown - 4.45Ease of use - 4.52Value for money - 4.67Customer support - 4.58Functionality Pricing Available upon request Get Price Alternative Product [ManualMaster](https://www.softwareadvice.com/document-version-control/manualmaster-profile/) 4.0 [(1)](https://www.softwareadvice.com/document-version-control/manualmaster-profile/#reviews) Ratings Breakdown - 3.0Ease of use - Value for money - 4.0Customer support - 4.0Functionality Pricing Starting at €20000.00 one time Get Price ## 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 Confused about pricing? We've got you covered. Get a personalized pricing breakdown tailored to your specific needs—no guesswork, no generic estimates. ## 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 Integration rated undefined from -1 review GitHub Integration rated undefined from -1 review Jira Integration rated undefined from -1 review TestRail Integration rated undefined from -1 review GitLab Integration rated undefined from -1 review Trello Integration rated undefined from -1 review See all 11 integrations ## Sierra QMS User Reviews Overall Rating 4.9 Ratings Breakdown 5 92% 4 8% 3 0% 2 0% 1 0% 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? AN Amber N. Verified reviewer Medical Devices 2-10 employees Used weekly for less than 12 months Reviewed May 2022 New to QMS 5 Great company, excellent expertise and would recommend 100%. Ratings Breakdown 5 Ease of use 5 Value for money 5 Customer support 5 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. Read More AP Ashoi P. Verified reviewer Computer Software 11-50 employees Used weekly for less than 12 months Reviewed March 2022 Highly capable Quality Management System 5 Ratings Breakdown 5 Ease of use 5 Value for money 5 Customer support 5 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 Read More RE Ryan E. Verified reviewer Computer Software 11-50 employees Used weekly for free trial Reviewed March 2022 Sierra QMS 4 Ratings Breakdown 5 Ease of use 4 Value for money 5 Customer support 4 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. Read More MP Michael P. Verified reviewer Health, Wellness and Fitness 2-10 employees Used weekly for less than 12 months Reviewed May 2022 Opio QMS review 5 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 5 Ease of use 5 Value for money 5 Customer support 5 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. Read More CB 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 5 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 5 Ease of use 5 Value for money 5 Customer support 4 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. Read More EM Emily M. Verified reviewer Hospital & Health Care 11-50 employees Used weekly for more than 2 years Reviewed May 2022 QMS for Healthcare Review 5 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 5 Ease of use 5 Value for money 5 Customer support 5 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. Read More KU Kwame U. Verified reviewer Medical Devices Self-Employed Used weekly for less than 2 years Reviewed March 2022 Sierra Labs Ease of Use 5 Ratings Breakdown 5 Ease of use 5 Value for money 5 Customer support 5 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 Read More ER 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 5 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 5 Ease of use 5 Customer support 5 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. Read More IM 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 5 Ratings Breakdown 5 Ease of use 5 Value for money 5 Customer support 5 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. Read More ET Evan T. Verified reviewer Medical Devices 11-50 employees Used monthly for less than 12 months Reviewed March 2022 Sierra QMS offers simple workflows. 5 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 5 Ease of use 5 Value for money 5 Customer support 4 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. Read More Showing 1 - 10 of 13 Reviews Load More Reviews ## Other Top Recommended Quality Management Software [JobBOSS²](https://www.softwareadvice.com/manufacturing/jobboss2-profile/) **4.2** (865) Recently recommended **77** times [Isolocity](https://www.softwareadvice.com/manufacturing/isolocity-profile/) **4.6** (65) Recently recommended **68** times [Unifize](https://www.softwareadvice.com/collaboration/unifize-profile/) **4.7** (11) Recently recommended **56** times [Propel](https://www.softwareadvice.com/manufacturing/propel-profile/) **4.4** (60) Recently recommended **54** times Stuck Between Options? Our experts can help you compare Sierra QMS with other top options, so you can find the best fit for your needs. ## See what companies are saying about Software Advice