Sierra QMS
Designed for healthcare and life science sectors, this Quality Management System seamlessly integrates with Atlassian Jira, enabling medical device, biotech, and pharmaceutical companies to manage workflows for 510(k) submissions and 21 CFR Part 820 compliance. It automates validation testing, tracks SOPs, and generates essential documentation for audits, ensuring regulatory adherence while simplifying processes.
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Top Sierra QMS Features
- Atlassian Jira integration
- Tailored for life sciences
- 510(k) submission workflows
- Compliance with 21 CFR Part 820
- SOP tracking capabilities
- GxP system inventory management
- Automated training for teams
- Customizable quality management reports
- Non-conformance and deviation tracking
- CAPA management tools
- Traditional document generation
- Scalable architecture
- FDA guidance alignment
- Automation of validation testing
- Streamlined approval processes
- Environment flexibility (local/cloud)
- Built-in policy drafting tools
- Quality record management
- Workflow improvement tracking
- Enterprise software testing automation
