This site does not duplicate authoritative content that lives elsewhere. The pages below are the canonical sources; this site links to them and explains how they fit together.
| Artefact | Path | What it is |
|---|
| Authoring rules + workflow definitions | .claude/skills/strictdoc-requirements/SKILL.md | Source of truth for terminology, type taxonomy, field shapes, review-state semantics, change-record process. The TRACE ALM site references this file repeatedly. |
| StrictDoc operational notes | dev-docs/strictdoc.md | Local install, export, server, version bumps, SOUP register |
| Codebase architecture | dev-docs/architecture.md | Hexagonal layout, dependency rules, code patterns |
| System / stakeholder requirements | regulatory-docs/10_system.sdoc | Device-level commitments (SYS- prefix) — IEC 62304 / ISO 29148 |
| Software requirements | regulatory-docs/11_srs.sdoc | Software-level requirements (SRS- prefix) — IEC 62304 §5.2 |
| Software architecture | regulatory-docs/20_architecture.sdoc | Architectural elements (ARCH- prefix) — subsystems, interfaces, SOUP, segregation — IEC 62304 §5.3 |
| Test specifications | regulatory-docs/ | UT / IT / ST specifications (30_unit_tests.sdoc, 31_integration_tests.sdoc, 32_system_tests.sdoc) |
| Change-record format | changes/README.md | YAML frontmatter, state transitions, parent/child propagation |
| Post-processor source | tools/post_processor/rtm.py | The interpretation engine |
| Auto-stamp source | tools/auto_stamp/ | The stamping logic |
| PR pipeline | .github/workflows/pr_branch_tests.yml | CI definition |
| Auto-stamp workflow | .github/workflows/auto-stamp.yml | Auto-stamp Action definition |
| CODEOWNERS | .github/CODEOWNERS | Reviewer policy |
| Standard | Scope |
|---|
| ISO 62304:2006+AMD1:2015 | Medical-device software lifecycle processes |
| ISO 14971:2019 | Application of risk management to medical devices |
| ISO 13485:2016 | Quality management systems for medical devices |
| IEC 81001-5-1 | Security activities in the product life cycle for health software |
| 21 CFR Part 11 | FDA — Electronic records; electronic signatures (subpart B sections §11.10, §11.30, §11.50, §11.70, §11.200) |
| HIPAA Security Rule | 45 CFR §164.312 |
| FDA Computer Software Assurance (CSA) guidance | Tool qualification for regulated workflows |
For the regulatory rationale of each TRACE ALM design decision — why a particular tool / configuration / process satisfies a particular standard clause — see the skill file, which carries source tags like [62304 §5.2.2] on every rule.