Paste your requirements. Get first-draft qualification protocols, a requirements traceability matrix, GAMP 5 risk categorization and a Part 11 gap checklist — structured the way an inspector reads them. Runs entirely in your browser; nothing you paste ever leaves it.
Give the generator your system context and requirements. GAMP category decides how much structural verification the software type warrants; risk decides which kinds of test the consequence warrants. Under-testing a high-risk function is a finding. Over-testing a low-risk one is not — but it spends assurance effort where it earns nothing, and every step you write becomes a step you must execute and defend.
Free tier generates the IQ protocol and the requirements traceability matrix from your requirements — complete, usable, and yours to export.
GAMP 5 category sets how deep the protocol goes. A Category 3 COTS product doesn't get Category 5 scrutiny — and the draft says so, which is what stops validation bloat.
Every generated test step links back to a requirement you supplied. The RTM lets an auditor follow the thread both ways: requirement → test → result, and back.
Drafts carry the review banner into every export. This accelerates the blank page; it never replaces the qualified reviewer, and it doesn't pretend to.
Per-seat subscriptions and shared team projects need a backend with real access control — deliberately not faked here. Today this is a one-time license that runs entirely on your machine, which is also why nothing you paste is ever transmitted.
No. There is no backend. Parsing, generation and export all happen in your browser — which matters when your requirements describe a regulated system. You can verify it: load the page, disconnect from the network, and it still works.
Not as-is, and any tool claiming otherwise should worry you. These are drafts. A qualified person must review, correct, approve and execute them inside your validated quality system. The review banner is embedded in every export so the draft status travels with the document.
It isn't, and it doesn't need to be — it holds no electronic records and applies no electronic signatures. Your records live in your validated systems. The Part 11 checklist here assesses your system's gaps, not this tool's.
Yes — the generator is risk-based by design, which is the heart of the FDA's Computer Software Assurance approach: concentrate effort where patient safety, product quality and data integrity are actually at stake, and use lighter verification elsewhere. The category and risk selectors drive exactly that.
Enter it here — it unlocks the full package on this device.
Enter your license code (from your receipt). It unlocks OQ/PQ protocols, the Part 11 gap checklist, deviation and VSR templates, and the AI review prompt on this device.
No code yet? See pricing →