--- description: Review of Sierra QMS Software: system overview, features, price and cost information. Get free demos and compare to similar programs on Software Advice Ireland. image: https://gdm-localsites-assets-gfprod.imgix.net/images/software_advice/og_logo-55146305bbe7b450bea05c18e9be9c9a.png title: Sierra QMS | Reviews, Pricing & Demos - SoftwareAdvice IE --- Breadcrumb: [Home](/) > [CAPA Management Software](/directory/4713/capa/software) > [Sierra QMS](/software/269951/sierra-qms) # Sierra QMS Canonical: https://www.softwareadvice.ie/software/269951/sierra-qms Page: 1 / 2\ Next: [Next page](https://www.softwareadvice.ie/software/269951/sierra-qms?page=2) > 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. Apply 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. > > Verdict: Rated **4.9/5** by 13 users. Top-rated for **Likelihood to recommend**. ----- ## Quick Stats & Ratings | Metric | Rating | Detail | | **Overall** | **4.9/5** | 13 Reviews | | Ease of Use | 5.0/5 | Based on overall reviews | | Customer Support | 5.0/5 | Based on overall reviews | | Value for Money | 4.9/5 | Based on overall reviews | | Features | 4.8/5 | Based on overall reviews | | Recommendation percentage | 100% | (10/10 Likelihood to recommend) | ## About the vendor - **Company**: Sierra Labs ## Commercial Context - **Pricing model**: Per User (Free Trial) - **Pricing Details**: 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. - **Target Audience**: 2–10, 11–50, 51–200, 201–500, 501–1,000, 1,001–5,000, 5,001–10,000, 10,000+ - **Deployment & Platforms**: Cloud, SaaS, Web-based, Mac (Desktop), Windows (Desktop), Linux (Desktop), Windows (On-Premise), Linux (On-Premise), Chromebook (Desktop) - **Supported Languages**: English - **Available Countries**: Afghanistan, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antigua & Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium and 208 more ## Features - API - Access Controls/Permissions - Activity Dashboard - Activity Tracking - Alerts/Escalation - Alerts/Notifications - Approval Process Control - Archiving & Retention - Assessment Management - Audit Management - Audit Trail - Automated Scheduling - Change Management - Collaboration Tools - Commenting/Notes - Communications Management - Complaint Management - Compliance Management - Compliance Tracking - Corrective and Preventive Actions (CAPA) ## Integrations (11 total) - Asana - AutoCAD - Bitbucket - Confluence - GitHub - GitLab - Jira - SolidWorks Premium - TestRail - Trello - monday.com ## Support Options - Email/Help Desk - Knowledge Base - Phone Support - Chat ## Category - [CAPA Management Software](https://www.softwareadvice.ie/directory/4713/capa/software) ## Related Categories - [CAPA Management Software](https://www.softwareadvice.ie/directory/4713/capa/software) - [Compliance Software](https://www.softwareadvice.ie/directory/4363/compliance/software) - [Quality Management Software](https://www.softwareadvice.ie/directory/420/quality-management-software/software) - [Document Control Software](https://www.softwareadvice.ie/directory/4233/document-control/software) - [Document Version Control Software](https://www.softwareadvice.ie/directory/4278/document-version-control/software) ## Alternatives 1. [QT9 QMS](https://www.softwareadvice.ie/software/152728/qt9) — 4.8/5 (117 reviews) 2. [MasterControl Quality Excellence](https://www.softwareadvice.ie/software/142000/mastercontrol) — 4.5/5 (526 reviews) 3. [Qualityze Suite](https://www.softwareadvice.ie/software/342094/qualityze-eqms-suite) — 4.9/5 (65 reviews) 4. [Intellect QMS AI](https://www.softwareadvice.ie/software/32288/intellect-workflow) — 4.6/5 (84 reviews) 5. [ManualMaster](https://www.softwareadvice.ie/software/447094/manualmaster) — 4.0/5 (1 reviews) ## Reviews ### "New to QMS" — 5.0/5 > **Amber** | *20 May 2022* | Medical Devices | Recommendation rating: 10.0/10 > > **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. > > Great company, excellent expertise and would recommend 100%. ----- ### "Highly capable Quality Management System" — 5.0/5 > **Ashoi** | *21 March 2022* | Computer Software | Recommendation rating: 10.0/10 > > **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. ----- ### "Sierra QMS" — 4.0/5 > **Ryan** | *21 March 2022* | Computer Software | Recommendation rating: 7.0/10 > > **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. ----- ### "Opio QMS review" — 5.0/5 > **Michael** | *20 May 2022* | Health, Wellness & Fitness | Recommendation rating: 10.0/10 > > **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. > > 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. ----- ### "Sierra QMS for Startup Medical Device Company" — 5.0/5 > **Carrie** | *25 March 2022* | Medical Devices | Recommendation rating: 10.0/10 > > **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. > > 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. ----- Page: 1 / 2\ Next: [Next page](https://www.softwareadvice.ie/software/269951/sierra-qms?page=2) ## Links - [View on SoftwareAdvice](https://www.softwareadvice.ie/software/269951/sierra-qms) ## This page is available in the following languages | Locale | URL | | en | | | en-AU | | | en-GB | | | en-IE | | | en-NZ | | ----- ## Structured Data