dearauditor-qms-baseline/CITATION.cff at main · AliakseiT/dearauditor-qms-baseline · GitHub

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cff-version: 1.2.0
message: If you reference this baseline in your work, cite it as below.
title: DearAuditor Open QMS Baseline
type: software
authors:
  - family-names: Tsitovich
    given-names: Aliaksei
    email: aliaksei@dearauditor.ch
repository-code: https://github.com/AliakseiT/dearauditor-qms-baseline
url: https://qms.dearauditor.ch
abstract: >-
  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 quality system of record.
  The baseline ships a Quality Manual, SOPs, work instructions, gap analyses,
  record templates, and workflow automation for ISO 9001, ISO 13485,
  ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1, ISO/IEC 27001,
  ISO/IEC 42001, GDPR, and the Swiss nFADP, plus an optional GAMP 5 / GxP
  overlay covering 21 CFR Part 11 and EU Annex 11 expectations.
keywords:
  - eQMS
  - QMS
  - quality management system
  - medical devices
  - SaMD
  - ISO 13485
  - IEC 62304
  - ISO 14971
  - 21 CFR Part 11
  - GAMP 5
  - regulatory compliance
license:
  - Apache-2.0
  - CC-BY-SA-4.0
version: QMS-2026-07-09-R005
date-released: '2026-07-09'