--- title: "Sierra QMS Software Pricing, Alternatives & More 2026 | Capterra" description: "With the help of Capterra, learn about Sierra QMS Software - reviews, pricing plans, popular comparisons to other SPC products and more." source_url: "https://www.capterra.com/p/233227/Sierra-QMS/" page_type: "product" language: "en" publication_date: "2026-10-19" --- # Sierra QMS Software Review 2026: Features, Integrations, Pros & Cons Last updated on October 19, 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)[FAQs](#faqs)[Features](#features)[Pricing](#pricing)[Integrations](#integrations)[Support](#support)[Reviews](#reviews) Sierra QMS ## What is Sierra QMS? Sierra QMS is a highly configurable easy to use Quality Management System (QMS) that helps agile teams with automation capabilities to ease the burdens of regulatory compliance. A QMS is meant to be built around your current organizational practices & not the other way around. This is why Sierra QMS integrates with the tools you already use & love! Sierra QMS allows faster innovation allowing you to get to the market faster and cheaper. ## 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 (71)](https://www.capterra.com/p/153199/Qualityze-EQMS-Suite/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 100% of reviewers rated it above 4 stars [4.8 (126)](https://www.capterra.com/p/97557/QT9-Quality-Management/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 95% of reviewers rated it above 4 stars [4.5 (580)](https://www.capterra.com/p/148577/MasterControl/reviews/) Starting price Contact vendor for pricing Pricing Options Free Trial Free Version User Rating 93% of reviewers rated it above 4 stars [4.7 (26)](https://www.capterra.com/p/141415/Adaptive-Compliance-Engine-ACE/reviews/) Starting price $500.00 Per User, Per Month Pricing Options Free Trial Free Version User Rating 96% of reviewers rated it above 4 stars ## FAQs about Sierra QMS Overview ### Which roles and teams benefit most from Sierra QMS? Sierra QMS benefits quality and compliance teams, including quality assurance managers and compliance engineers, who manage controlled documents, audits, corrective actions, and regulatory records. Operations leaders and executives use it to oversee quality processes and accountability, while product, development, and system administration teams coordinate change controls, approvals, and release-related documentation. Answer based on 13 reviews Overview ### What company size and industries is Sierra QMS built for? Sierra QMS is for small Medical Device companies, which account for 100% of reviewers, and related regulated health sectors. Its intended audience includes SaMD, biotech, pharmaceutical, digital health, DTx, and clinical research organizations. Reviewer industries are Medical Devices (46%), Computer Software (23%), and Hospital & Health Care (15%). Answer based on 13 reviews Features and Usability ### What are the key features of Sierra QMS? Sierra QMS offers quality and compliance management features such as CAPA, audit management, complaint management, and risk assessment. It also includes document management, workflow automation, approval process control, and audit trails, plus reporting, alerts, digital signatures, and role-based permissions for tracking controlled processes and records. Integrations ### Which third-party tools and platforms does Sierra QMS integrate with? Sierra QMS integrates with Jira, Asana, AutoCAD, Bitbucket, Confluence, GitHub, GitLab, SolidWorks Premium, TestRail, Trello, and monday.com AI Work Platform. Jira is the most commonly mentioned integration, and the catalog shows coverage across project management, development, document collaboration, and engineering tools. Answer based on 3 reviews Getting Started and Support ### What training and onboarding options does Sierra QMS offer? Sierra QMS provides in person training, live online sessions, webinars, documentation, and videos. In person and live online formats support guided instruction, webinars cover topic-based learning, documentation offers written reference material, and videos provide visual walkthroughs for reviewing features and procedures. Getting Started and Support ### What customer support options does Sierra QMS offer? Sierra QMS provides email/help desk, a knowledge base, phone support, and chat. These channels give users several ways to get assistance and self-serve help. No reviewer feedback is available here to describe response times, helpfulness, or common support frustrations. ## Features AI summary Based on 2,611 SPC reviews Capterra data shows that buyers of Quality Management software rank the following features as their top priorities: - **Document Management** (**54%** of reviewers rated this feature as critical) - **Quality Control** (**50%**) - **Compliance Management** (**44%**) Sierra QMS supports all three features that reviewers rate most highly: **Document Management**, **Quality Control**, and **Compliance Management**. Together, these capabilities help businesses keep records organized, maintain consistent product and process standards, and stay aligned with regulatory requirements, allowing teams to improve oversight and reduce quality-related risks. Compliance Management 4.5 (2) 100.00% of 2 reviewers that rated this feature as important or highly important Track and manage adherence to policies for any service, product, process, or supplier 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 Corrective and Preventive Actions (CAPA) 5.0 (3) 33.33% of 3 reviewers that rated this feature as important or highly important Investigate and take action at root cause or error in processes to prevent recurring issues 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 Sierra QMS 99 features ### All Features - Access Controls/Permissions: Define levels of authorization for access to specific files or systems - Activity Dashboard: Dashboard to view the status of ongoing processes, identify current incidents and track past activities - Activity Tracking: Track and document all activities across devices, networks, and other systems - Alerts/Escalation: System alerts about the need to escalate an issue or request - Alerts/Notifications: Alerts or notifications of various types such as pop-up messages, sounds, banners, or badges - API: Application programming interface that allows for integration with other systems/databases - Approval Process Control: Manage the process of evaluating documents or requests submitted for approval - Archiving & Retention: Moving and separately storing data that is not actively used or continuous storage of data for compliance purposes - Assessment Management: Creation, administration, and evaluation of assessments or tests - Audit Management: Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws - Audit Trail: A record of all activities within the system, including user access, changes made, etc. - Automated Scheduling: Automatically create schedules based on business needs or employee availability and qualifications - Change Management: Track and monitor efficient handling of all changes/transitions - Collaboration Tools: Provides a channel for team members to share AI models, media files, communicate, and work together - Commenting/Notes: Leave comments and notes on documents for others to view - Communications Management: Record and track all relevant internal and external communications - Complaint Management: Obtain, monitor, and review customer feedback/complaints relating to products and services to improve customer satisfaction - Compliance Management: Track and manage adherence to policies for any service, product, process, or supplier - Compliance Tracking: Track and report regulatory data to either internal management or external stakeholders - Corrective and Preventive Actions (CAPA): Investigate and take action at root cause or error in processes to prevent recurring issues - Customizable Fields: Customize data fields to support various needs and use cases - Customizable Reports: Alter the layout and content of reports - Customizable Templates: Pre-designed layouts that can be customized to match preferences and requirements - Dashboard: Assembly of graphs and charts for visualizing and tracking statistics/metrics - Data Import/Export: Import and export data to and from software applications - Data Visualization: Graphical representation of data - Defect Tracking: Process of tracking logged defects (errors) in a product or service to create new versions to fix the error - Digital Signature: Electronic signing method that validates the authenticity and integrity of a digital document - Document Automation: Automated or logic-based workflows that assist in the creation of electronic documents - Document Check-in/Check-out: Document Check-in/Check-out - Document Coding & Control: Management and control of the creation, approval, and distribution of documents and processes to ensure they meet industry regulations - Document Management: Store, manage, and track all electronic documents in a centralized location - Document Review: Review and analyze existing information across documents - Document Storage: Store and organize documents in a centralized system - Document Templates: Customizable sample documents that contain placeholder text or a standard layout that can be repeated for each new file - Drag & Drop: Assemble applications and processes by dragging over and arranging pre-built components - Electronic Signature: Digitally sign online documents - Email Alerts: Receive and/or send email notifications for urgent updates, requests, or other information - Environmental Compliance: Guidelines for conforming to environmental laws, regulations and requirements - Equipment Management: Monitor and maintain equipment used to manufacture and deploy products and services, and to reallocate assets where needed - FDA Compliance: Track and ensure quality of products in accordance with food and drug administration (FDA) act - File Management: Create, save, and store files - Forms Management: Store, manage and track all forms in a centralized location - Full Text Search: Search for specific words or phrases within a document or database - HIPAA Compliant: Compliant with HIPAA, which sets standards for sensitive patient data protection - Incident Management: Manage and track all disruptions and incidents - Indexing: Compile and organize data into specific metrics - Inspection Management: Track and manage inspections for worksites, vehicles, and/or equipment to remain compliant with industry standards - Internal Controls Management: Ensure internal objectives and compliance with policies are met - ISO Compliance: Guidelines set by the International Organization for Standardization - ISO Standards Management: Track and monitor processes/products to ensure they meet international standards developed by the ISO - IT Risk Management: Manage risks related to IT systems - Maintenance Management: Manage, maintain and track the performance of assets and equipment - Metadata Management: Collect and maintain structured information that describes data or content - Mobile Access: Access software remotely via mobile devices - Monitoring: Observe and track the demand, usage, progress or quality of a system, product, or user - Multiple Format Support: Includes a variety of messaging formats including industry-specific (EDIFACT, HL7, X12) - Nonconformance Tracking: Identify issues and deviations from specifications - Operational Risk Management: Manage risk that occurs from systems failure or inadequate processes - OSHA Compliance: Enforces guidelines set by the Occupational Safety and Health Administration to remain legally compliant - Policy Management: Create, manage, and track policies and procedures within an organization - Predictive Analytics: Predict future data based on historical data sets - Quality Control: Ensure that quality requirements and standards are met across production processes - Real-Time Analytics: Analyze and gain insights into data in real-time - Real-Time Data: Receive data and information in real time - Real-Time Monitoring: Active monitoring of systems, applications, or networks - Real-Time Notifications: Notifications that are delivered to users as soon as an event occurs - Real-Time Reporting: Active reporting of data and metrics - Real-Time Updates: Receive system updates as soon as any changes are made - Reminders: Timed notification for any upcoming task, deadline, appointment, or activity - Reporting & Statistics: Collection, analysis, and representation of numerical data and generation of reports to understand various patterns - Reporting/Analytics: View and track pertinent metrics to find patterns and gain insights from data - Response Management: Planning and managing of resources and procedures to mitigate the impact of events and incidents - Revision History: Track what was updated, who made the changes, compare two revisions, and revert or perform another revision - Risk Analysis: Analyze potential risks across the organization - Risk Assessment: Initiate collection and analysis of known risks - Risk Management: Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties - Risk Reporting: Reporting of risks associated with specific actions, events, or entities - Risk Scoring: Assess and score risks using risk matrices - Role-Based Permissions: Set & manage permission levels based on user roles and restrict access to only authorized individuals - Root Cause Analysis: Identify and analyse the reasons behind accidents - Rules-Based Workflow: Automates and streamlines business processes by creating a sequence of predefined rules and actions that govern the flow of work - Sarbanes-Oxley Compliance: Regulations on a company's internal process when dealing with financial reporting - Search/Filter: Search and filter data across systems to locate required information by entering keywords or certain criteria - Secure Data Storage: Securely stores data to prevent data loss or breaches - SSL Security: Security protocol that ensures secure, encrypted communication over the internet, safeguarding sensitive data from unauthorized access - Status Tracking: Track the status over time for a request, process, asset, or transaction - Supplier Management: Manage all supplier data and operations - Supplier Quality Control: Qualify, select, and monitor supply chain partners - Surveys & Feedback: Gauge satisfaction and receive information for improvement and success - Tagging: Attach digital tags to documents and assets for identification, search, or monitoring purposes - Task Management: Create, manage and track all task activities and progression - Third-Party Integrations: Set up connections to third-party platforms to improve business processes - Traceability: Track and document the history, application, or location of an item or activity - Training Management: Track employee/learner's progression through training programs - Version Comparison: The process of cross-checking new versions with previous copies to identify changes - Version Control: Track revisions and updates made to files and navigate between different versions - Version Rollback: The process of reverting to a previous version or state - Workflow Management: 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) 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 AI Work Platform](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 Counts reflect reviews available in this feed. 5(12) 4(1) 3(0) 2(0) 1(0) Mentioned topic Recent reviews first, then most helpful RE Reviewer CEO Used the software for: Less than 1 year ### "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 24, 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. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Compliance Engineer Used the software for: Less than 1 year ### "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 July 4, 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. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Developer Used the software for: I used a free trial ### "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 July 4, 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 Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Co-Founder Used the software for: Less than 1 year ### "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 24, 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. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Quality Assurance Manager Used the software for: Less than 1 year ### "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 28, 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. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Executive Assistant Used the software for: 3-5 years ### "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 23, 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 Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Principal Used the software for: 1-3 years ### "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 25, 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 Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. Eric R. Product Manager Used the software for: Less than 1 year ### "Most straightforward & simple QMS I've Used" 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 9/10 March 21, 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. Review source Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Chief Operating Officer Used the software for: Less than 1 year ### "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 12, 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 Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. RE Reviewer Vice President Used the software for: Less than 1 year ### "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 24, 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 Non-incentivized review: any software user can leave a review for any product listed on our site. All submitted reviews are subject to our verification process prior to publication. 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