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Guide · Agent skill

How to use the FDA QSR Audit Prep agent skill

Updated · written with AI from the project's own documentation and checked against our catalogue data

The fda-qsr-audit-prep skill is a set of instructions that makes an AI agent act like a strict FDA auditor reviewing a US medical device company's quality system under 21 CFR 820, the Quality System Regulation now known as QMSR. This guide explains what the skill does, how to install it, how to trigger it, and what it needs before it runs. By the end you will be able to run a structured mock inspection and read the readiness report it produces.

FDA QSR Audit Prepalirezarezvani/claude-skills · MIT

Quick start

  1. 1Download the ZIP. Download the skill ZIP from this page and unzip it. Confirm that SKILL.md is present.
  2. 2Place the skill folder. Move the folder into ~/.claude/skills/ for personal use, or into .claude/skills/ inside your project. Alternatively, upload it under Settings → Capabilities → Skills in the Claude apps.
  3. 3Prepare the input files. Create compliance_state.json, submissions.json, phi_inventory.json and fda_qsr_scope.json from your own records.
  4. 4Confirm the vendor scripts. Make sure the ra-qm-team and compliance-os scripts the workflow calls are available, since they are not included in the reviewed file.
  5. 5Run the audit with a scope. Invoke the skill with /compliance-os:fda-qsr-audit-prep followed by your scope, or ask for a mock FDA inspection in plain language.
  6. 6Review the readiness report. Check the figures against your records, then review the verdict and top three actions.
  7. 7Escalate outside-counsel items. Send any Warning Letter response, recall decision or 510(k) or PMA strategy dispute to qualified outside counsel.

What the skill makes the agent do

The skill asks six hard questions, one at a time, covering complaints and medical device reporting (MDR), process validation, device history records (DHRs), corrective and preventive actions (CAPAs), labeling, and past FDA observations (Form 483s). Each question names the regulation it tests, such as 21 CFR 820.198 for complaints or 21 CFR 820.180 for DHR retention.

After the questions, the skill produces a structured readiness report. It includes a traffic-light verdict (INSPECTION-READY, GAPS-IDENTIFIED or NOT-READY), a top three list of actions with owners and timelines, and a separate section stating which items need outside counsel.

  • Use it before an annual internal QSR audit.
  • Use it before an FDA inspection readiness review.
  • Use it after receiving a Form 483, a Warning Letter or an MDR-reportable event.
  • Use it before a recall decision or a 510(k) or PMA submission.

Install the skill by ZIP download

Download the ZIP file from this page and unzip it. The skill's main file is SKILL.md. Place the unzipped folder in one of two locations: your personal skills folder at ~/.claude/skills/, or a project-specific folder at .claude/skills/ inside your project directory.

If you use the Claude apps instead of a local setup, you can upload the skill under Settings → Capabilities → Skills.

  • Personal install: ~/.claude/skills/
  • Project install: .claude/skills/ inside the project folder
  • Claude apps: Settings → Capabilities → Skills, then upload

Prepare the input files

The workflow reads local JSON files. The source names four: compliance_state.json, submissions.json, phi_inventory.json and fda_qsr_scope.json. Gather your own records into these files before you run the audit. The skill does not pull data from your systems.

The workflow also calls several Python scripts from vendor folders (ra-qm-team and compliance-os). The source notes that these scripts are not included in the file reviewed, so you must have them available for the workflow to run as written.

  • compliance_state.json: overall QSR compliance posture
  • submissions.json: FDA submission tracking for 510(k), PMA or IDE
  • phi_inventory.json: protected health information inventory, if a connected device handles PHI
  • fda_qsr_scope.json: the mock inspection scope

Trigger the skill with a natural request

You can invoke the skill with the command form shown in its description, followed by a scope in place of [scope]. You can also ask the agent in plain language, for example that you want a mock FDA inspection of your quality system or a readiness review before an annual internal audit. Name the scope you want covered so the report is focused.

The command form from the skill is:

  • Ask for a mock FDA inspection of the complaint handling process for our Class II infusion pump line.
  • Run an inspection-readiness review of our DHRs before the next FDA visit.
  • Help me prepare a response to our recent Form 483 observations.
/compliance-os:fda-qsr-audit-prep <scope>

Read the output and act on it

The report is organized by topic: complaint and MDR posture, process validation status, DHR completeness, CAPA health, labeling, Form 483 and Warning Letter history, and an ISO 13485 cross-walk. Check each figure against your own records, because the skill structures the review but does not verify your files.

Treat the top three actions as a starting list. Assign an owner to each and confirm the timeline against the regulation the report cites.

  • Verdict colours: green is INSPECTION-READY, yellow is GAPS-IDENTIFIED, red is NOT-READY.
  • Aging CAPAs older than 90 days are flagged in the report.
  • Items under Outside Counsel Required should go to qualified counsel.

Safety notes: scripts and network

The skill runs Python scripts, so review them before you run the workflow on sensitive records. The source states that the skill runs scripts and does not use the network. Keep your input files local and confirm the script paths match the folders you have installed.

The skill is licensed under MIT.

  • Runs scripts: yes. Requires Python.
  • Uses network: no, according to the source.
  • Input files contain quality and possibly patient-related data, so store them under your own access controls.

Tips for a useful audit

The quality of the report depends on the quality of your input files. Fill in real figures from your complaint log, DHR set and CAPA system rather than estimates. Run the skill on a defined scope, such as one product line, so the findings stay specific.

Use the ISO 13485 cross-walk section if you also run an ISO 13485 audit, since the skill notes that the two are substantially harmonized after February 2026.

  • Start with one product line to test your inputs.
  • Keep a copy of each run's output with its input files.
  • Do not treat a green verdict as proof of compliance.

What people use it for

  • Running a mock FDA inspection of a device line before an announced inspection.
  • Preparing a structured review of complaint files and MDR decisions for the last quarter.
  • Checking DHR completeness and CAPA effectiveness evidence during an annual internal QSR audit.
  • Organizing the closure status of past Form 483 observations before a response.
  • Giving a consultant a structured checklist for reviewing a US medical device maker's quality system.

Frequently asked questions

Is the FDA QSR Audit Prep skill free?

The source says the skill is licensed under MIT. Check the license file in the repository for the full terms before you use or redistribute it.

What do I need to run the fda-qsr-audit-prep skill?

You need Python, the four local JSON input files named in the source, and the referenced vendor scripts from the ra-qm-team and compliance-os folders. The source notes those vendor scripts are not included in the file reviewed.

Where do I install the skill?

Unzip the downloaded ZIP into ~/.claude/skills/ for personal use or .claude/skills/ inside a project. In the Claude apps, you can upload it under Settings → Capabilities → Skills.

Does this skill check my actual records for compliance?

No. The source says it only structures a review and does not check your actual records, so every figure must be verified against your own documents.

Can the skill replace a regulatory consultant or lawyer?

No. The skill is not for final regulatory decisions or legal advice. Its output says Warning Letter responses, recall decisions and 510(k) or PMA strategy disputes need outside counsel.

Does this skill work for companies outside the US?

The source says it is for US medical device companies. FDA rules do not apply to companies outside the US medical-device context, so the skill is not suited to them.

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Our verdict

Use this skill if you are a quality or regulatory team, or a consultant, preparing for an internal QSR audit, an FDA inspection or a Form 483 response for a US medical device. Pick something else if you need legal advice, final regulatory decisions, or a tool that checks your records automatically, or if your products are not regulated by the FDA.

Download the skill