Open Source

The AI approval boundary nobody talks about until the audit finds it

The first time I saw an AI approve a CAPA closure, I'll admit I paused. Not because the decision was wrong — it wasn't — but because I couldn't find…

The cleanest way to keep your compliance‑AI out of the EU AI Act high‑risk class: AI proposes, a human approves and signs

I nearly signed off on an "auto‑close" feature for an AI that triaged evidence requests. It would have saved the team hours a week. We didn't enable…

Picking an eQMS for a 200-person Class II device shop — a pragmatic comparison

I work in a 200-person Class II medical device company with two QA/RA folks, three embedded-hardware teams, a small supplier-quality group, and engi…

Where usability files actually break — and what I do about it

I stopped treating the usability file as a compliance artifact years ago — it’s where product design and real people collide. When it’s done badly,…