CAPA-Auto: The Build Guide

How do we handle CAPA and complaints properly with three people? A step-by-step build guide for founders: design,

build, price, and launch a cloud QMS add-on that automates CAPA workflow, complaint handling, and MDR

documentation assistance for small and mid-sized medical device manufacturers.

THE PROOF

35% of FDA 483 findings trace to CAPA, complaints & design controls

WHAT IT SETTLES

Run CAPA and Complaints Without a QMS Team.

In the package: 62 pages · 6 diagrams · 100+ AI prompts