---
title: "Industry Standards"
description: "Traceability requirements in DO-178C, ISO 26262, IEC 62304, and other standards"
---

# Industry Standards for Traceability

Many industries require traceability as part of regulatory compliance. This guide covers the major standards and how TraceRTM helps you meet their requirements.

## Overview of Standards

| Standard | Industry | Traceability Requirement |
|----------|----------|-------------------------|
| DO-178C | Aerospace | Bidirectional trace, all levels |
| ISO 26262 | Automotive | Safety requirements traced |
| IEC 62304 | Medical Devices | Software requirements traced |
| FDA 21 CFR Part 11 | Pharmaceutical | Audit trails, electronic records |
| ISO 27001 | Information Security | Change management traced |
| CMMI | General | Process area requirements |
| IEEE 830 | General | Requirements specification |

## Aerospace: DO-178C

### Overview

DO-178C (Software Considerations in Airborne Systems and Equipment Certification) is the primary standard for aerospace software certification.

### Traceability Requirements

DO-178C requires **bidirectional traceability** at all Design Assurance Levels (DAL):

```
High-Level Requirements (HLR)
        ↕ (bidirectional)
Low-Level Requirements (LLR)
        ↕ (bidirectional)
Source Code
        ↕ (bidirectional)
Test Cases
        ↕ (bidirectional)
Test Results
```

### Requirements by DAL Level

| DAL | Level | Traceability Requirements |
|-----|-------|--------------------------|
| A | Catastrophic | Full bidirectional, 100% coverage |
| B | Hazardous | Full bidirectional, 100% coverage |
| C | Major | Bidirectional, high coverage |
| D | Minor | Forward traceability required |
| E | No Effect | Minimal requirements |

### TraceRTM Configuration

```yaml
# .tracertm/config.yaml
compliance:
  standard: DO-178C
  dal_level: B

traceability:
  directions: [forward, backward]
  required_coverage: 100

  required_traces:
    - from: high_level_requirement
      to: low_level_requirement
      bidirectional: true

    - from: low_level_requirement
      to: source_code
      bidirectional: true

    - from: source_code
      to: test_case
      bidirectional: true

    - from: test_case
      to: test_result
      bidirectional: true

audit:
  change_tracking: required
  baseline_management: required
  electronic_signatures: required
```

### Compliance Report

```bash
tracertm report compliance --standard DO-178C --dal B

# Output:
# DO-178C DAL B Compliance Report
# ═══════════════════════════════════════════
#
# Traceability Coverage:
#   HLR → LLR: 100% ✓
#   LLR → Code: 100% ✓
#   Code → Test: 98% ✗ (2 modules untested)
#   Test → Results: 100% ✓
#
# Bidirectional Traces:
#   All required traces: ✓
#
# Issues:
#   - CODE-042: No test coverage
#   - CODE-089: No test coverage
#
# Status: NOT COMPLIANT (fix 2 issues)
```

## Automotive: ISO 26262

### Overview

ISO 26262 (Road Vehicles - Functional Safety) covers functional safety for automotive electrical/electronic systems.

### Traceability Requirements

ISO 26262 requires traceability for safety-related requirements:

```
Safety Goals
    ↓
Functional Safety Requirements
    ↓
Technical Safety Requirements
    ↓
Software Safety Requirements
    ↓
Software Architecture
    ↓
Software Unit Design
    ↓
Software Unit Implementation
    ↓
Software Unit Verification
```

### ASIL Levels

| ASIL | Risk Level | Traceability Required |
|------|------------|----------------------|
| D | Highest | Full bidirectional |
| C | High | Full bidirectional |
| B | Medium | Forward + key backward |
| A | Low | Forward traceability |
| QM | Quality | Recommended |

### TraceRTM Configuration

```yaml
# .tracertm/config.yaml
compliance:
  standard: ISO-26262
  asil_level: C

traceability:
  required_traces:
    - from: safety_goal
      to: functional_safety_req
      bidirectional: true

    - from: functional_safety_req
      to: technical_safety_req
      bidirectional: true

    - from: software_safety_req
      to: software_unit
      bidirectional: true

    - from: software_unit
      to: verification
      bidirectional: true

  safety_classification:
    enabled: true
    inherit_from_parent: true
```

### Safety Traceability Report

```bash
tracertm report safety --standard ISO-26262 --asil C

# Output:
# ISO 26262 ASIL C Safety Traceability Report
# ═══════════════════════════════════════════
#
# Safety Goals Traced: 12/12 (100%) ✓
# Functional Safety Requirements: 45/45 (100%) ✓
# Technical Safety Requirements: 128/130 (98%) ✗
# Software Requirements: 256/260 (98%) ✗
# Verification Coverage: 95% ✗
#
# Gaps:
#   TSR-042: Not traced to software requirement
#   TSR-089: Not traced to software requirement
#   SWREQ-201..204: No verification evidence
#
# ASIL Inheritance Check:
#   All safety requirements properly classified ✓
```

## Medical Devices: IEC 62304

### Overview

IEC 62304 (Medical Device Software - Software Life Cycle Processes) defines software development requirements for medical devices.

### Traceability Requirements

```
Software Requirements
    ↓
Software Architecture
    ↓
Software Detailed Design
    ↓
Software Unit Implementation
    ↓
Software Unit Verification
    ↓
Software Integration Testing
    ↓
Software System Testing
```

### Software Safety Classes

| Class | Risk | Traceability |
|-------|------|--------------|
| A | No injury possible | Basic traceability |
| B | Non-serious injury | Forward + verification |
| C | Death or serious injury | Full bidirectional |

### TraceRTM Configuration

```yaml
# .tracertm/config.yaml
compliance:
  standard: IEC-62304
  safety_class: C

traceability:
  required_traces:
    - from: software_requirement
      to: architecture
      bidirectional: true

    - from: architecture
      to: detailed_design
      bidirectional: true

    - from: detailed_design
      to: unit_implementation
      bidirectional: true

    - from: unit_implementation
      to: unit_verification
      required: true

risk_management:
  integration: required
  hazard_traceability: true
```

## FDA: 21 CFR Part 11

### Overview

21 CFR Part 11 establishes requirements for electronic records and electronic signatures in FDA-regulated industries.

### Requirements

| Requirement | Description |
|-------------|-------------|
| Audit Trails | Track all changes to records |
| Electronic Signatures | Authenticate record creators |
| Access Controls | Role-based permissions |
| Data Integrity | Prevent unauthorized changes |

### TraceRTM Configuration

```yaml
# .tracertm/config.yaml
compliance:
  standard: FDA-21-CFR-Part-11

audit:
  enabled: true
  retention_years: 7

  track:
    - item_created
    - item_updated
    - item_deleted
    - link_created
    - link_deleted
    - status_changed
    - baseline_created

electronic_signatures:
  enabled: true
  require_for:
    - baseline_approval
    - release_approval
    - change_approval

access_control:
  rbac: true
  require_authentication: true
  session_timeout: 30m
```

### Audit Trail Report

```bash
tracertm report audit --standard FDA-21-CFR-Part-11 --period 90d

# Output:
# FDA 21 CFR Part 11 Audit Report
# ═══════════════════════════════════════════
# Period: September 1 - November 30, 2024
#
# Change Summary:
#   Items created: 234
#   Items modified: 567
#   Items deleted: 12
#   Links created: 890
#   Status changes: 456
#
# Electronic Signatures:
#   Baselines approved: 3
#   Releases approved: 2
#   All signatures valid: ✓
#
# Access Control Events:
#   Login attempts: 1,234
#   Failed logins: 23
#   Permission changes: 5
#
# Data Integrity:
#   Hash verification: All records valid ✓
#   No unauthorized modifications detected ✓
```

## General: CMMI

### Overview

CMMI (Capability Maturity Model Integration) provides process improvement guidance across industries.

### Requirements Management (REQM)

| Practice | Traceability Aspect |
|----------|---------------------|
| SP 1.1 | Understand requirements |
| SP 1.2 | Obtain commitment |
| SP 1.3 | Manage changes |
| SP 1.4 | Maintain bidirectional traceability |
| SP 1.5 | Identify inconsistencies |

### TraceRTM Support

```yaml
# .tracertm/config.yaml
compliance:
  framework: CMMI
  level: 3

traceability:
  bidirectional: true

change_management:
  approval_workflow: true
  impact_analysis_required: true

consistency_checks:
  - orphan_detection
  - cycle_detection
  - coverage_analysis
```

## IEEE 830

### Overview

IEEE 830 (Recommended Practice for Software Requirements Specifications) provides guidance for writing requirements.

### Traceability Section

IEEE 830 recommends including traceability information in requirements:

```markdown
## 3.2.1 User Login (FEAT-001)

### Description
The system shall allow users to authenticate with email and password.

### Traces
- **Source**: Business Need BN-003 (Self-service access)
- **Implements**: Use Case UC-001 (User Authentication)
- **Verified by**: TEST-001, TEST-002, TEST-003
- **Implemented in**: CODE-001 (auth_handler.py)

### Priority
High

### Rationale
Required for secure access to user-specific functionality.
```

## Implementing Compliance

### Step 1: Select Standards

```yaml
# .tracertm/config.yaml
compliance:
  standards:
    - name: IEC-62304
      safety_class: C
    - name: FDA-21-CFR-Part-11
      audit_retention: 7years
```

### Step 2: Configure Traceability Rules

```yaml
traceability:
  rules:
    - name: "All requirements must have tests"
      from_type: requirement
      to_type: test
      link_type: verified_by
      min_count: 1

    - name: "All code must trace to requirements"
      from_type: code
      to_type: requirement
      link_type: implements
      min_count: 1
```

### Step 3: Enable Audit Trails

```yaml
audit:
  enabled: true
  events:
    - all
  retention: 7years
  export_format: json
```

### Step 4: Generate Compliance Reports

```bash
# Generate all compliance reports
tracertm report compliance --all --output compliance-package/

# Output:
# Generated:
#   compliance-package/iec-62304-report.pdf
#   compliance-package/fda-21-cfr-11-audit.pdf
#   compliance-package/traceability-matrix.pdf
#   compliance-package/coverage-report.pdf
#   compliance-package/change-history.pdf
```

### Step 5: Maintain During Development

```yaml
# CI/CD compliance checks
- name: Compliance Validation
  run: |
    tracertm validate --compliance IEC-62304
    tracertm validate --compliance FDA-21-CFR-Part-11
```

## Summary

| Standard | Key Requirements | TraceRTM Support |
|----------|-----------------|------------------|
| DO-178C | Bidirectional, full coverage | ✓ Full |
| ISO 26262 | Safety traceability | ✓ Full |
| IEC 62304 | Software lifecycle traces | ✓ Full |
| FDA 21 CFR Part 11 | Audit trails, e-signatures | ✓ Full |
| CMMI | Requirements management | ✓ Full |
| IEEE 830 | Requirements documentation | ✓ Full |

## Related Topics

- [What is Traceability?](/docs/wiki/concepts/traceability/what-is) - Fundamentals
- [Types of Traceability](/docs/wiki/concepts/traceability/types) - Different approaches
- [Best Practices](/docs/wiki/concepts/traceability/best-practices) - Implementation guidance
- [Generating Reports](/docs/getting-started/first-project/reports) - Compliance reports

