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Safety & Compliance

Functional safety and ASPICE tools

Functional safety (ISO 26262) and process assessment (ASPICE) are mandatory requirements in automotive development. These tools support hazard analysis, FMEA, safety case construction, requirements management, and full lifecycle traceability. medini analyze is the specialist tool for safety analysis, while ALM platforms like Polarion and DOORS provide the requirements traceability and change management infrastructure that auditors expect to see in certified projects.

Key Use Cases

Hazard analysis and risk assessment (HARA)
FMEA / FTA / FMEDA analysis
Safety case documentation and argumentation
Requirements management and traceability
ASPICE process compliance tracking
Change management and impact analysis

Tools in Detail

medini analyze
Tool Image /tools/safety-compliance/images/medini-analyze.png

medini analyze

Specialist safety analysis tool from Ansys. Supports HARA, FTA, FMEA, FMEDA, and safety concept development following ISO 26262. The go-to tool for functional safety engineers at OEMs and Tier-1s.

Ansys SCADE
Tool Image /tools/safety-compliance/images/ansys-scade.png

Ansys SCADE

Qualified model-based development environment with built-in safety analysis. KCG code generator is certified to ISO 26262 ASIL D, providing guaranteed code correctness by construction.

APIS IQ-FMEA
Tool Image /tools/safety-compliance/images/apis-iq-fmea.png

APIS IQ-FMEA

FMEA authoring and management tool widely used in German automotive. Supports structure trees, function nets, and failure nets following VDA/AIAG FMEA handbook methodology.

Polarion ALM
Tool Image /tools/safety-compliance/images/polarion-alm.png

Polarion ALM

Siemens' application lifecycle management platform. Provides requirements management, test management, and traceability with built-in ASPICE and ISO 26262 project templates.

PTC Integrity (Windchill)
Tool Image /tools/safety-compliance/images/ptc-integrity-windchill.png

PTC Integrity (Windchill)

Requirements and change management platform. Strong in configuration management and variant handling, widely used at OEMs for managing complex multi-variant ECU projects.

IBM DOORS / DOORS Next
Tool Image /tools/safety-compliance/images/ibm-doors-doors-next.png

IBM DOORS / DOORS Next

The most established requirements management tool in automotive. Provides rich traceability, baselining, and change impact analysis. DOORS Next adds web-based collaboration.

Jama Connect
Tool Image /tools/safety-compliance/images/jama-connect.png

Jama Connect

Modern cloud-based requirements management platform. Provides live traceability, review workflows, and risk management with a more intuitive UX than legacy tools.

Industry Context

ISO 26262 compliance is not optional - it's a legal and contractual requirement. The standard mandates specific engineering activities and tool-supported traceability from safety goals through requirements, design, implementation, and testing. ASPICE adds process maturity requirements. Together they create substantial tooling needs: safety analysis tools (FMEA/FTA), requirements management platforms, and documentation systems. The cost is significant, but a safety-related recall is orders of magnitude more expensive.

Typical Workflow

Starting at concept phase with HARA (medini analyze) to determine ASIL levels. Safety goals decompose into functional then technical safety requirements, managed in Polarion/DOORS/Jama with traceability. FMEA identifies failure modes driving additional requirements. Development follows ASPICE processes. Verification links back to requirements. The safety case - the structured argument the system is safe - accumulates evidence from all tools and processes throughout.

Selection Guide

Scenario
ISO 26262 safety analysis (HARA, FTA, FMEA)
→ medini analyze
Purpose-built for automotive functional safety with integrated analysis methods.
Scenario
Requirements management for ASPICE Level 3
→ Polarion ALM
Automotive-specific templates, bidirectional traceability, web-based collaboration.
Scenario
Legacy OEM programs with existing databases
→ IBM DOORS
Deeply embedded at major OEMs; existing databases often cannot be migrated.
Scenario
New programs seeking modern UX
→ Jama Connect
Modern interface with real-time impact analysis and API-first architecture.

Pro Tips

1

Establish traceability structure at project start - retrofitting before ASPICE assessment is extremely painful.

2

Keep safety analyses in sync with design - outdated FMEAs are a major finding in ISO 26262 audits.

3

Use requirements attributes (ASIL, status, verification method) consistently for automated completeness checks.

4

Plan for requirements changes - your tools and processes must handle change management with impact analysis.

5

The safety case is not one document at the end - it's a living argument. Start building from day one.

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