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Sierra QMS
Based on GetApp‘s extensive, proprietary database of in-depth, verified user reviews
Automate Regulatory Compliance and Speed Your Innovations!
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Sierra QMS - 2026 Pricing, Features, Reviews & Alternatives
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Sierra QMS overview
What is Sierra QMS?
Sierra QMS is a highly configurable and customizable Quality Management System (QMS) that harnesses agile technology and automation capabilities to ease the burdens of regulatory compliance. Our system was specifically built for Healthcare and Life Science companies to reduce the stress of FDA (and other regulatory bodies) compliance, lower compliance costs, and accelerate your time to market.
Our system is designed to support the management of 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, Pharmaceutical, Digital Health, 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, trainings, 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. We are proud partners with AWS and Atlassian. Our 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!
Key benefits of using Sierra QMS
- Risk Management: Create and track non-conformance and CAPAs with deep linking to related policies, audit
events, trainings, 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.
Starting price
Alternatives
Sierra QMS’s user interface
Sierra QMS reviews
Overall rating
4.9
/5
13
Positive reviews
100
%
- Value for money
- Ease of use
- Features
- Customer support
- Likelihood to recommend9.69/10
5
4
3
2
1
12
1
0
0
0
Who uses Sierra QMS?
Based on 13 verified user reviews.
Company size
Small Businesses
Enterprises
Midsize Businesses
Top industries
Use cases
Sierra QMS's key features
Most critical features, based on insights from Sierra QMS users:
All Sierra QMS features
Features rating:
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ARMATURE
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24000
Integrum
Starting from
750
Per month
Sierra QMS pricing
Value for money rating:
Starting from
No pricing info
User opinions about Sierra QMS price and value
Value for money rating:
Sierra QMS integrations (11)
Integrations rated by users
We looked at 13 user reviews to identify which products are mentioned as Sierra QMS integrations and how users feel about them.
Integration rating: 5.0 (1)
Other top integrations
Sierra QMS support options
Typical customers
Platforms supported
Support options
Training options
Sierra QMS FAQs
Sierra QMS has the following pricing plans:
Pricing model: Subscription
Free Trial: Available | (No Credit Card required)
Q. Who are the typical users of Sierra QMS?
Sierra QMS has the following typical customers:
Large Enterprises, Mid Size Business, Small Business
Q. What languages does Sierra QMS support?
Sierra QMS supports the following languages:
English
Q. Does Sierra QMS offer an API?
Yes, Sierra QMS has an API available for use.
Q. What other apps does Sierra QMS integrate with?
Sierra QMS integrates with the following applications:
GitHub, Jira, Trello, SolidWorks Premium, GitLab, AutoCAD, Bitbucket, Confluence, monday.com, Asana, TestRail
Q. What level of support does Sierra QMS offer?
Sierra QMS offers the following support options:
Email/Help Desk, Knowledge Base, Phone Support, Chat