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

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Company Details

Company:
Sierra Labs
Headquarters:
United States
Website:
www.sierralabs.com/quality-management/

Media

Sierra QMS Screenshot 1
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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

Sierra QMS User Reviews

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