Audience
Organizations in need of a healthcare and life science Quality Management system
About Sierra QMS
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review.
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Integrations
No integrations listed.
Company Information
Sierra Labs
United States
www.sierralabs.com/quality-management/
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Product Details
Platforms Supported
Cloud
Training
Documentation
Support
Online
Sierra QMS Product Features
CAPA
Audit Management
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
CAPA Planning
Compliance
Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Artificial Intelligence (AI)
Controls Testing
HIPAA Compliance
Risk Management
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Periodic Review
Version Control
Escalation Management
Document Version Control
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Document Control
Risk Management
Alerts/Notifications
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Exceptions Management
IT Risk Management
Internal Controls Management
Mobile Access
Operational Risk Management
Predictive Analytics
Response Management
Risk Assessment
Auditing
Dashboard
Legal Risk Management
Reputation Risk Management