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Articles

On running a quality management system in GitHub, by the maintainers of the DearAuditor Open QMS Baseline.

Can GitHub really work as an eQMS? Taking the objections seriously

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

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.