# Sierra QMS Software Pricing, Alternatives & More 2026 | Capterra > With the help of Capterra, learn about Sierra QMS Software - reviews, pricing plans, popular comparisons to other Compliance products and more. Source: https://www.capterra.com/p/233227/Sierra-QMS --- # Sierra QMS Software Review 2026: Features, Integrations, Pros & Cons Last updated on March 13, 2026 Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Description](#description)[Use cases](#use-cases)[Alternatives](#alternatives)[Features](#features)[Pricing](#pricing)[Integrations](#integrations)[Support](#support)[Reviews](#reviews) Sierra QMS ## What is Sierra QMS? Sierra Lab’s QMS will seamlessly integrate with your operations to ensure that regulatory compliance needs are automated and a by product of your operations. Our system is highly customizable and can be as light or robust as needed for your organization’s current processes. Configure your teams workflows for managing CAPAs, non-conformances, and document trainings. Electronic signatures can be applied to all items for recording approvals directly in the system. Dashboards and notifications are ## What is Sierra QMS used for? [Quality Management](https://www.capterra.com/quality-management-software/)[Document Control](https://www.capterra.com/document-control-software/)[Document Version Control](https://www.capterra.com/document-version-control-software/) Overall rating Based on 13 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price Free trial available Capterra Shortlist charts the highest-rated and most popular products... Our "Best of" badge program showcases products with the highest ratings... Our "Best of" badge program showcases products with the highest ratings... ## Sierra QMS alternatives Highest Rated [4.9 (65)](https://www.capterra.com/p/153199/Qualityze-EQMS-Suite/reviews/) Starting price Contact vendor for pricing [4.5 (526)](https://www.capterra.com/p/148577/MasterControl/reviews/) Starting price $25000.00 Per User, Per Month [4.8 (117)](https://www.capterra.com/p/97557/QT9-Quality-Management/reviews/) Starting price Contact vendor for pricing [4.4 (74)](https://www.capterra.com/p/192574/Dot-Compliance/reviews/) Starting price Contact vendor for pricing ## Features Features with the highest number of reviews are displayed first. Those that have no reviews appear next, sorted alphabetically. Change Management 5.0 (7) 57.14% of 7 reviewers that rated this feature as important or highly important Track and monitor efficient handling of all changes/transitions Alerts/Notifications 5.0 (4) 50.00% of 4 reviewers that rated this feature as important or highly important Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges Risk Management 4.5 (4) 50.00% of 4 reviewers that rated this feature as important or highly important Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties Supplier Quality Control 4.5 (4) 50.00% of 4 reviewers that rated this feature as important or highly important Qualify, select, and monitor supply chain partners Training Management 4.8 (4) 25.00% of 4 reviewers that rated this feature as important or highly important Track employee/learner's progression through training programs Version Control 4.8 (4) 25.00% of 4 reviewers that rated this feature as important or highly important Track revisions and updates made to files and navigate between different versions Sierra QMS 95 features Define levels of authorization for access to specific files or systems Dashboard to view the status of ongoing processes, identify current incidents and track past activities Track and document all activities across devices, networks, and other systems System alerts about the need to escalate an issue or request Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges Application programming interface that allows for integration with other systems/databases Manage the process of evaluating documents or requests submitted for approval Moving and separately storing data that is not actively used or continuous storage of data for compliance purposes Creation, administration, and evaluation of assessments or tests Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws A record of all activities within the system, including user access, changes made, etc. Automatically create schedules based on business needs or employee availability and qualifications Track and monitor efficient handling of all changes/transitions Provides a channel for team members to share media files, communicate, and work together Leave comments and notes on documents for others to view Record and track all relevant internal and external communications Obtain, monitor, and review customer feedback/complaints relating to products and services to improve customer satisfaction Track and manage adherence to policies for any service, product, process, or supplier Track and report regulatory data to either internal management or external stakeholders Investigate and take action at root cause or error in processes to prevent recurring issues Alter the layout and content of reports Pre-designed layouts that can be customized to match preferences and requirements Assembly of graphs and charts for visualizing and tracking statistics/metrics Import and export data to and from software applications Graphical representation of data Process of tracking logged defects (errors) in a product or service to create new versions to fix the error Electronic signing method that validates the authenticity and integrity of a digital document Automated or logic-based workflows that assist in the creation of electronic documents Document Check-in/Check-out Management and control of the creation, approval, and distribution of documents and processes to ensure they meet industry regulations Store, manage, and track all electronic documents in a centralized location Review and analyze existing information across documents Store and organize documents in a centralized system Customizable sample documents that contain placeholder text or a standard layout that can be repeated for each new file Assemble applications and processes by dragging over and arranging pre-built components Digitally sign online documents Receive and/or send email notifications for urgent updates, requests, or other information Guidelines for conforming to environmental laws, regulations and requirements Monitor and maintain equipment used to manufacture and deploy products and services, and to reallocate assets where needed Track and ensure quality of products in accordance with food and drug administration (FDA) act Create, save, and store files Store, manage and track all forms in a centralized location Search for specific words or phrases within a document or database Compliant with HIPAA, which sets standards for sensitive patient data protection Manage and track all disruptions and incidents Compile and organize data into specific metrics Track and manage inspections for worksites, vehicles, and/or equipment to remain compliant with industry standards Ensure internal objectives and compliance with policies are met Guidelines set by the International Organization for Standardization Track and monitor processes/products to ensure they meet international standards developed by the ISO Manage risks related to IT systems Manage, maintain and track the performance of assets and equipment Collect and maintain structured information that describes data or content Access software remotely via mobile devices Observe and track the demand, usage, progress or quality of a system, product, or user Includes a variety of messaging formats including industry-specific (EDIFACT, HL7, X12) Identify issues and deviations from specifications Manage risk that occurs from systems failure or inadequate processes Enforces guidelines set by the Occupational Safety and Health Administration to remain legally compliant Create, manage, and track policies and procedures within an organization Predict future data based on historical data sets Ensure that quality requirements and standards are met across production processes Receive data and information in real time Active monitoring of systems, applications, or networks Notifications that are delivered to users as soon as an event occurs Active reporting of data and metrics Receive system updates as soon as any changes are made Timed notification for any upcoming task, deadline, appointment, or activity Collection, analysis, and representation of numerical data and generation of reports to understand various patterns Planning and managing of resources and procedures to mitigate the impact of events and incidents Track what was updated, who made the changes, compare two revisions, and revert or perform another revision Analyze potential risks across the organization Initiate collection and analysis of known risks Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties Reporting of risks associated with specific actions, events, or entities Assess and score risks using risk matrices Set & manage permission levels based on user roles and restrict access to only authorized individuals Identify and analyse the reasons behind accidents Automates and streamlines business processes by creating a sequence of predefined rules and actions that govern the flow of work Regulations on a company's internal process when dealing with financial reporting Search and filter data across systems to locate required information by entering keywords or certain criteria Securely stores data to prevent data loss or breaches Security protocol that ensures secure, encrypted communication over the internet, safeguarding sensitive data from unauthorized access Track the status over time for a request, process, asset, or transaction Manage all supplier data and operations Qualify, select, and monitor supply chain partners Gauge satisfaction and receive information for improvement and success Attach digital tags to documents and assets for identification, search, or monitoring purposes Create, manage and track all task activities and progression Set up connections to third-party platforms to improve business processes Track employee/learner's progression through training programs The process of cross-checking new versions with previous copies to identify changes Track revisions and updates made to files and navigate between different versions The process of reverting to a previous version or state Create, design and manage workflows for repetitive tasks Get Advice We can help you find the software with the features you need. Features 4.8 (13) 4.8 Based on 13 reviews ## Pricing Value for money 4.9 (12) ### Starting price Free trial available Value for money 4.9 (12) 4.9 Based on 12 reviews ## Integrations [ Trello](https://www.capterra.com/p/211559/Trello/)[ Jira](https://www.capterra.com/p/19319/JIRA/)[ Asana](https://www.capterra.com/p/184581/Asana-PM/)[ GitHub](https://www.capterra.com/p/129067/GitHub/)[ monday.com](https://www.capterra.com/p/147657/monday-com/)[ Confluence](https://www.capterra.com/p/136446/Confluence/)[ AutoCAD](https://www.capterra.com/p/265024/AutoCAD/)[ Bitbucket](https://www.capterra.com/p/233341/Bitbucket/) Connect with a Capterra advisor for a free 15-minute consultation Get a personalized software list aligned to your business needs with guidance from our expert advisors. Our team has helped 1 million+ businesses like yours find options that fit their needs. ## Support, customer service and training options Customer Service 5.0 (13) Support - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - 24/7 (Live rep) - Chat Training - In Person - Live Online - Webinars - Documentation - Videos Deployment - Web - Android - iPhone/iPad Typical users - Freelancers - Small businesses - Mid size businesses - Enterprises Customer Service 5.0 (13) 5.0 Based on 13 reviews ## User reviews Overall rating 4.9 Based on 13 reviews Filter by rating 5(12) 4(1) 3(0) 2(0) 1(0) Mentioned topic Sorted by most recent MP Michael P. Co-Founder Health, Wellness and Fitness ### "Opio QMS review" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 May 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](https://www.capterra.com/p/140578/greenlight-guru/) Reasons for choosing Sierra QMS Simply to use at a better cost point with available help to build our system from scratch. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. AN Amber N. CEO Medical Devices ### "New to QMS" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 May 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](https://www.capterra.com/p/140578/greenlight-guru/) [Qualio](https://www.capterra.com/p/134050/Quality-Management-Software/) Reasons for choosing Sierra QMS Greenlight Guru was too pushy and it was overpriced for what we needed - a lot of add on costs. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. EM Emily M. Executive Assistant Hospital & Health Care ### "QMS for Healthcare Review" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 May 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. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. IM Ian M. Chief Operating Officer Medical Devices ### "Great Product for a Great Price" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 April 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. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. AK Arin K. Consultant Medical Devices ### "Great QMS!" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 April 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. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. CB Carrie B. Quality Assurance Manager Medical Devices ### "Sierra QMS for Startup Medical Device Company" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 March 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. Reasons for choosing Sierra QMS Sierra QMS was more configurable, more affordable, and had a more intuitive user interface. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. KU Kwame U. Principal Medical Devices ### "Sierra Labs Ease of Use" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 March 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 Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. ET Evan T. Vice President Medical Devices ### "Sierra QMS offers simple workflows." 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 March 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. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. RE Ryan E. Developer Computer Software ### "Sierra QMS " 4.0 Overall Rating 4.0 4.0 Ease of Use 5.0 5.0 Features 4.0 4.0 Customer Service 5.0 5.0 Likelihood to Recommend 7/10 March 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. Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. AP Ashoi P. Compliance Engineer Computer Software ### "Highly capable Quality Management System" 5.0 Overall Rating 5.0 5.0 Ease of Use 5.0 5.0 Features 5.0 5.0 Customer Service 5.0 5.0 Likelihood to Recommend 10/10 March 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](https://www.capterra.com/p/140578/greenlight-guru/) [Qualio](https://www.capterra.com/p/134050/Quality-Management-Software/) Reasons for choosing Sierra QMS Cheaper and easier to use, while supporting greater integration options with other software tools Review source Incentivized review: software users are invited to submit an honest review and offered a nominal incentive for their time and effort. All incentivized reviews are subject to our verification process prior to publication. [View all Reviews](https://www.capterra.com/p/233227/Sierra-QMS/reviews/) Independent research methodology Capterra's researchers use a mix of verified reviews, independent research and objective methodologies to bring you selection and ranking information you can trust. While we may earn a referral fee when you visit a provider through our links or speak to an advisor, this has no influence on our research or methodology. 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