Getting Started
New to the solution? Start here to install, configure, and run your first risk analysis.- Getting Started — Installation, your first HARA analysis, and a V-Model traceability walkthrough
Concepts
Understand the architecture before diving into workflows.- Concepts — Solution overview, ISO 14971 coverage, dual risk methodology, data model, traceability chain, and risk matrix model
How-To Guides
Task-focused guides for daily risk management work.- HARA Analysis Workflows — Identify hazards, evaluate risk, assign controls, assess residual risk
- DFMEA Analysis Workflows — Identify failure modes, score RPN, add mitigation actions
- PFMEA Analysis Workflows — Create and manage process FMEAs
- Solution Setup — Create system elements, risk documents, and configure views
- Reports and Dashboards — Generate HARA reports, read risk matrices, review DFMEA summaries
- Approval Workflows — Review, approve, and rework risk documents
Reference
Facts-only documentation for configuration, fields, and enumerations.- Work Item Types — All 16 work item types with custom fields
- Enumerations — Severity scales, probability levels, risk classifications
- Risksheet Configurations — HARA, DFMEA, PFMEA, and Risk Control Plan column layouts
- PowerSheet Configurations — RTM, verification, and validation sheet setups
- Dashboards and Reports — Project home, HARA report, risk matrix, DFMEA summary
FAQ
- Frequently Asked Questions — Common questions about HARA workflows, DFMEA, and ISO 14971 compliance