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Generate Safety Case
Automatically generate comprehensive safety cases with evidence and compliance documentation for regulatory approval.
Automated Safety Case Generation
Learn how to use Saphira to automatically generate comprehensive safety cases with evidence and compliance documentation! Saphira provides complete CE Mark Technical File generation capabilities, enabling full preparation for CE Mark and UL Mark certification.Start Safety Case Generation
Initiate Safety Case Generation
Initiate Safety Case Generation
From your project dashboard, navigate to the Safety Case view. Saphira will analyze your risk assessment, control measures, and safety functions to automatically generate a comprehensive safety case.
Evidence Integration
Evidence Integration
Upload supporting documents, test reports, and compliance evidence. Saphira will automatically link these to relevant safety functions and requirements in your safety case.
Safety Case Components
Safety Goals and Requirements
Safety Goals and Requirements
Saphira automatically extracts safety goals from your risk assessment and maps them to specific safety requirements. Each goal includes:
- Clear safety objectives derived from hazard analysis
- Specific performance criteria and acceptance limits
- Traceability to relevant standards and regulations
- Evidence requirements for verification and validation
Traceability Matrix
Traceability Matrix
The system automatically generates a comprehensive traceability matrix showing:
- Links between hazards, safety goals, and safety functions
- Connections to specific standards clauses and requirements
- Evidence mapping for each safety requirement
- Verification and validation coverage analysis
Evidence Management
Evidence Management
Saphira organizes and validates evidence for your safety case:
- Automatic linking of test reports and validation documents
- Gap analysis for missing evidence
- Evidence quality assessment and recommendations
- Compliance status tracking for each requirement
Advanced Safety Case Features
Multi-Standard Compliance
Multi-Standard Compliance
Generate safety cases that comply with multiple standards simultaneously:
- ISO 13849 for functional safety
- IEC 62061 for safety integrity levels
- ISO 10218 for industrial robots
- IEC 61508 for general functional safety
- Custom standards and regulations
Automated Documentation
Automated Documentation
Saphira automatically generates:
- Executive summaries with compliance status
- Detailed safety case arguments (GSN format)
- Evidence summaries and gap analysis
- Risk assessment documentation
- Verification and validation reports
CE Mark & UL Certification Support
CE Mark & UL Certification Support
Complete CE Mark Technical Files and UL certification preparation:
- Full CE Mark Technical File generation
- UL Mark certification documentation
- Notified body report generation (UL, TUV, Intertek, Pilz)
- Machinery Directive 2006/42/EC compliance
- Low Voltage Directive 2014/35/EU compliance
- EMC Directive 2014/30/EU compliance
- Custom regulatory format templates
Safety Case Workflow
Initial Assessment
Initial Assessment
Start with your existing risk assessment and safety functions. Saphira analyzes your project data to identify:
- Safety goals and performance requirements
- Required evidence and documentation
- Compliance gaps and recommendations
- Regulatory approval requirements
Evidence Collection
Evidence Collection
Upload and organize supporting evidence:
- Test reports and validation documents
- Design specifications and drawings
- Risk assessment documentation
- Compliance certificates and approvals
Generation and Review
Generation and Review
Saphira generates your safety case and provides:
- Comprehensive safety case document
- Evidence mapping and traceability
- Gap analysis and recommendations
- Compliance status dashboard
Export and Submission
Export and Submission
Export your safety case in various formats:
- Complete CE Mark Technical File
- UL Mark certification package
- PDF reports for regulatory submission
- Structured data for further analysis
- Custom templates for specific authorities
- Integration with existing documentation systems