Skip to content
TRACE ALM Documentation

TRACE ALM Documentation

Traceability, Requirements, and Compliance Engine — the in-house ALM stack we built around BioFlow Pro and intend to reuse on future regulated software products.
What TRACE ALM is Apply to a new project

Where to start

Section titled “Where to start”

Overview

A 5-minute read explaining what TRACE ALM is, which tools compose it, and how they integrate. Read the overview →

Tooling reference

One page per tool: StrictDoc, the post-processor, VisionTrace, Allure, the auto-stamp App, and Signet. Browse the tooling →

Setup playbooks

Auditable, step-by-step records of every admin action that built TRACE ALM on this repo. Open the playbooks →

21 CFR Part 11 strategy

How TRACE ALM’s two-layer signing chain (auto-stamp + Signet) satisfies §11.10. Read the strategy →

What this site is for

Section titled “What this site is for”

TRACE ALM is the integrated set of tools and conventions that, together, replace what a single commercial ALM suite would do for a regulated medical-software project. This site is its living record — what is built, why, by whom, and exactly how to operate or extend it.

Three audiences shape every page:

  1. Future auditors — FDA, ISO 62304, ISO 14971 — who need to trace a deployed binary back to every approval that contributed to it.
  2. New developers — who need to set up a workstation, understand which tool does what, and add new requirements or tests.
  3. The current team and external stakeholders — who need a fast reference when something breaks, needs extending, or has to be explained to a regulatory consultant.

If a page reads like marketing, it’s wrong.