Sierra QMS Description
These workflows will help you create everything you need for a 510(k), and create quality records for 21 CFR Part 820 when you are ready to sell your device. Built-in tools for creating policies, procedures, or work instructions. With customized quality management reports, you can track non-conformances, deviations and CAPAs. Keep your team trained as you improve and scale your policies, workflows, and procedures. Automate validation testing for devices, apps, web and custom-made software. Reduce the time and resources required for lengthy testing, reporting, approvals, and other tasks. All your policies, procedures, artifacts can be converted into traditional documents for audit review.
Integrations
No Integrations at this time
Company Details
Company:
Sierra Labs
Headquarters:
United States
Website:
www.sierralabs.com/quality-management/
Media
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Explore how a customer data platform can help to enhance your engineering team's efficiency and supercharge application performance.
Product Details
Platforms
SaaS
Type of Training
Documentation
Customer Support
Online
Sierra QMS Features and Options
Compliance Software
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Risk Management Software
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment
Quality Management Software
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Document Version Control Software
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
CAPA Software
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Document Control Software
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control