QMSR Gap Assessment Workbook — FDA QMSR and ISO 13485 compliance workbook

QMSR Gap Assessment Kit

$99.00

An AI assistant that runs your QMSR gap assessment as an interview, and a six-worksheet Excel workbook it fills in with you.

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$99 · ONE-TIME · WORKBOOK + AI ASSISTANT

QMSR Gap Assessment Kit

An AI assistant that runs your QMSR gap assessment as an interview. It asks for the procedures and records an inspection would look at, records what it finds, and fills in the workbook as you go.

  • Runs in your own Claude or ChatGPT account
  • Six-worksheet Excel workbook, filled in as you work
  • Covers the 28 legacy QSR sections, the FDA-specific requirements kept in Part 820, and the inspection areas of Compliance Program 7382.850
  • Your documents never leave your AI account
  • Unlimited internal use

Get the kit

Start free, then document the work

Use the free checklist to see where you stand. Use the kit to record what was found, assign owners, and track each gap to closure.

$99 USD

How it works

  1. Load it. Add the instructions and the reference file to a Claude Project or a ChatGPT project. No software to install.
  2. Answer and upload. The assistant scopes your company, then works through each area of your quality system. It asks for procedure titles, record examples and how the work is actually done. You can upload your own SOPs for it to review.
  3. Get the record. Each finding goes into the workbook: requirement, evidence, gap, risk, owner, action, target date. You finish with a prioritized summary and a closure plan.

What’s included

  • QMSR Gap Assessment Workbook (Excel, six worksheets)
  • AI assistant instructions for Claude and ChatGPT
  • Assistant reference file: sheet map, evidence prompts, risk guide
  • Quick-start guide (PDF)

What it is, and what it isn’t

The kit structures the assessment and drafts the findings. Your qualified personnel review them and own the conclusions. It does not determine compliance or predict the outcome of an inspection.

Why the ISO 13485 text isn’t in the kit

Since February 2, 2026, FDA’s Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference. That makes the standard part of the regulation. It does not put the text in the public domain: ISO holds the copyright and sells the standard under licence.

So the kit cites clauses by number and explains requirements in our own words. ISO’s licence terms also restrict using ISO publications with AI tools without a separate licence. For that reason the assistant will not read a copy of the standard, even one you own. When exact wording matters, it tells you which clause to check in your copy.

You can read the standard free of charge, or buy your own copy:

FDA lists both read-only options in its QMSR frequently asked questions.

FAQ

Which AI do I need? A Claude or ChatGPT plan that lets you create a project with custom instructions and uploaded files.

Does AVRA see my documents? No. Everything runs inside your own AI account. Check your company’s policy on AI tools before uploading controlled documents.

Can I run more than one assessment? Yes. The licence covers unlimited internal use within your company.

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