A step-by-step build guide for founders: design, build, price, and launch CAPA-Auto — a cloud QMS add-on that automates CAPA workflow, complaint handling, and MDR documentation assistance for small and mid-sized device makers. 62 pages. 6 data-backed diagrams. 100+ AI prompts.
CAPA and complaint handling are consistently among the most frequently cited FDA Form 483 observation categories for device manufacturers. And with the new Quality Management System Regulation (QMSR) now in effect, most small and mid-sized manufacturers are not ready.
A complete, stage-by-stage manual for building a lightweight cloud QMS add-on — not a full eQMS replacement — that automates CAPA tracking, complaint routing, root-cause workspaces, and MDR documentation assistance, with an AI layer that drafts and organizes while every regulatory judgment stays with a qualified human.
The six-stage CAPA lifecycle every quality event runs through, and exactly where AI assists versus where a human must decide.
Six concrete build stages — foundation, workflow engine, AI layer, complaint/MDR module, audit-readiness, and interface.
A researched three-tier pricing ladder, a customer-acquisition playbook, and the metrics that predict whether it's working.
| Without This Guide | With CAPA-Auto: The Build Guide |
|---|---|
| A vague idea to "build something in compliance/AI" | A researched, scoped product with a defined ICP and a real pricing anchor |
| Guessing at architecture and where AI should (and shouldn't) act | A reference architecture and an auditable human-approval boundary, built into the schema |
| No idea what to charge or how to position against "contact us" competitors | A three-tier pricing ladder benchmarked against real market anchors |
| Starting content and outreach from a blank page | 100+ ready-to-use prompts and a 90-day launch plan with weekly milestones |
A dedicated prompt set for reviewing AI-facing copy and features for regulatory-safe language.
A full before/after walkthrough of a hypothetical customer's 12-month rollout, with charts.
Straight answers to the questions you'll actually get from early customers and advisors.
Awaiting first reader review.
Awaiting first reader review.
Awaiting first reader review.
No — but the guide is explicit that you should engage a regulatory advisor before shipping regulated-industry features, and it tells you exactly when and why.
No. Every AI capability described is scoped as assistive — drafting, summarizing, and organizing — with human review and approval required before anything becomes an official record. This boundary is covered in detail in Chapter 5.
A 62-page PDF, delivered instantly after checkout.
No. It's a business and product build guide, not a substitute for qualified regulatory affairs counsel or a licensed attorney — see the disclaimer on the guide's first page.
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If CAPA-Auto: The Build Guide isn't the right fit for you, email us within 7 days of purchase for a full, no-questions-asked refund.
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