# DearAuditor Open eQMS

> An open-source, GitHub-native electronic Quality Management System (eQMS) baseline for medical device and regulated software teams. GitHub Issues, Pull Requests, Actions, and Releases form the system of record; companies fork the baseline, tailor it, validate it, and run their QMS entirely in Git. Covers ISO 9001, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1, ISO/IEC 27001, ISO/IEC 42001, GDPR, Swiss nFADP, and an optional GAMP 5 / GxP (21 CFR Part 11, EU Annex 11) overlay.

Current published baseline release: QMS-2026-07-09-R005 (https://github.com/AliakseiT/dearauditor-qms-baseline/releases/tag/QMS-2026-07-09-R005).
Licensing: Apache-2.0 for code and automation, CC BY-SA 4.0 for documents. Contact: aliaksei@dearauditor.ch.

## Docs

- [README — project overview and navigation](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/README.md): start here
- [QM-001 Quality Manual](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/qm/QM-001-QualityManual.md): top-level policy and scope
- [Open-source adoption model](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/docs/open-source/README.md): how a company adopts the baseline
- [Adoption profiles overview](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/docs/adoption/README.md): which parts apply to which product type
- [Adoption profiles — detail](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/docs/adoption/profiles.md): standards mapping per application scenario
- [System architecture](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/docs/architecture/README.md): workflows, automations, trust boundaries
- [Bootstrap example](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/examples/bootstrap/README.md): example matrices and records for a new adopter

## Repository

- [Baseline repository](https://github.com/AliakseiT/dearauditor-qms-baseline): SOPs, work instructions, gap analyses, records, tooling
- [Releases](https://github.com/AliakseiT/dearauditor-qms-baseline/releases): immutable published QMS baseline versions (QMS-YYYY-MM-DD-RNNN)
- [License](https://raw.githubusercontent.com/AliakseiT/dearauditor-qms-baseline/main/LICENSE): split licensing terms

## Articles

- [Can GitHub really work as an eQMS? Taking the objections seriously](https://qms.dearauditor.ch/articles/can-github-work-as-an-eqms): OpenRegulatory stopped recommending git-based QMS after client projects failed. Most of their observations are correct. What they describe, though, is a bare repository full of markdown files, not an engineered system.
- [Part 11 electronic signatures on pull requests](https://qms.dearauditor.ch/articles/part-11-signatures-on-pull-requests): Why a bare GitHub approval fails 21 CFR Part 11, and how a Cloudflare Worker with a time-limited PIN turns it into a signature record that binds identity, meaning, timestamp and revision.

## Optional

- [Full project summary for LLMs](https://qms.dearauditor.ch/llms-full.txt): landing-page content, adoption scenarios, and FAQ in one document
- [DearAuditor toolset](https://dearauditor.ch): AI-assisted technical-documentation auditing application