Paper to Chinese Patent Drafter
Yuan1z0825/nature-skills
Drafts Chinese invention patent applications and technical disclosures from research papers or inventor materials, tying each claim feature to source evidence.
/cs:fda-qsr-audit-prep <scope — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation.
Install Fda Qsr Audit Prep
$ npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install alirezarezvani/claude-skills fda-qsr-audit-prep --agent claude-codeProject scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/compliance-os/skills/fda-qsr-audit-prep .claude/skills/fda-qsr-audit-prep && rm -rf skills-srcUse ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.
Claude Code skills documentation · loads skills from .claude/skills/
Install the "fda-qsr-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prep into .claude/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", then confirm the skill loads.Claude Code copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$skill-installer install https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prepType this inside Codex. $skill-installer <name> installs a curated skill from openai/skills. The installer writes to $CODEX_HOME/skills (default ~/.codex/skills). Restart Codex if the skill does not show up.
$ npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install alirezarezvani/claude-skills fda-qsr-audit-prep --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .agents/skills && cp -r skills-src/compliance-os/skills/fda-qsr-audit-prep .agents/skills/fda-qsr-audit-prep && rm -rf skills-srcUse ~/.agents/skills/ instead of .agents/skills for a personal install.
Codex skills documentation · loads skills from .agents/skills/
Install the "fda-qsr-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prep into .agents/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", then confirm the skill loads.Codex copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install alirezarezvani/claude-skills fda-qsr-audit-prep --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/compliance-os/skills/fda-qsr-audit-prep .cursor/skills/fda-qsr-audit-prep && rm -rf skills-srcUse ~/.cursor/skills/ instead of .cursor/skills for a personal install.
Cursor skills documentation · loads skills from .cursor/skills/, .agents/skills/, .claude/skills/, .codex/skills/
Install the "fda-qsr-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prep into .cursor/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", then confirm the skill loads.Cursor copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gemini skills install https://github.com/alirezarezvani/claude-skills.git --path compliance-os/skills/fda-qsr-audit-prep--scope user (default) or --scope workspace; --path is the subfolder of the repo that holds the skill; --consent skips the security confirmation prompt.
$ npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install alirezarezvani/claude-skills fda-qsr-audit-prep --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/compliance-os/skills/fda-qsr-audit-prep .gemini/skills/fda-qsr-audit-prep && rm -rf skills-srcUse ~/.gemini/skills/ instead of .gemini/skills for a personal install, then run /skills reload.
Gemini CLI skills documentation · loads skills from .gemini/skills/, .agents/skills/
Install the "fda-qsr-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prep into .gemini/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", then confirm the skill loads.Gemini CLI copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gh skill install alirezarezvani/claude-skills fda-qsr-audit-prepInstalls for Copilot at project scope by default; add --scope user for a personal install. Preview a skill first with gh skill preview. Needs GitHub CLI 2.90.0 or later (public preview).
$ npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .github/skills && cp -r skills-src/compliance-os/skills/fda-qsr-audit-prep .github/skills/fda-qsr-audit-prep && rm -rf skills-srcUse ~/.copilot/skills/ instead of .github/skills for a personal install. Commit .github/skills so cloud agent and code review can use it.
GitHub Copilot skills documentation · loads skills from .github/skills/, .claude/skills/, .agents/skills/
Install the "fda-qsr-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prep into .github/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", then confirm the skill loads.GitHub Copilot copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install alirezarezvani/claude-skills fda-qsr-audit-prep --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/compliance-os/skills/fda-qsr-audit-prep .opencode/skills/fda-qsr-audit-prep && rm -rf skills-srcUse ~/.config/opencode/skills/ instead of .opencode/skills for a personal install.
OpenCode skills documentation · loads skills from .opencode/skills/, .claude/skills/, .agents/skills/
Install the "fda-qsr-audit-prep" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/compliance-os/skills/fda-qsr-audit-prep into .opencode/skills/fda-qsr-audit-prep/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-qsr-audit-prep", then confirm the skill loads.OpenCode copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
Facts
- Skill name
fda-qsr-audit-prep- GitHub stars
- 28k
- Token cost
- ~1.6k tokens
- SKILL.md length
- 456 words
- Files
- 1
- Skills in repo
- 342
- Repo updated
- First seen
- Licence
- MIT
At a glance
/cs:fda-qsr-audit-prep <scope — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation.
- Works in 6 steps: Show me the complaint files from the… → When was process validation (IQ/OQ/PQ)… → Show me the DHRs for products… → …
- Legal & Compliance work in your project
- SKILL.md covers When to Run, The Six QSR Questions, Workflow and Output Format, plus 2 more sections
- Calls python
What it does
Fda Qsr Audit Prep is an agent skill from alirezarezvani/claude-skills. /cs:fda-qsr-audit-prep <scope — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.
Its SKILL.md is about 1.6k tokens, which your agent loads only when the skill is triggered. It is a single SKILL.md file with no bundled scripts.
It sits in Legal & Compliance. The repository describes itself as: 380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8… The licence is MIT.
When your agent uses it
- Legal & Compliance work in your project
Example prompts
- “/fda-qsr-audit-prep”
Requirements
- Python 3
Workflow steps
6 steps, taken from the step headings in SKILL.md.
- Show me the complaint files from the last quarter — and the corresponding MDR reports.
- When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75?
- Show me the DHRs for products commercially distributed in last 2 years.
- Show me CAPAs from the last 6 months with effectiveness verification.
- Show me labeling (21 CFR 801) review for the most recent product launch.
- If a Form 483 was issued in the last 3 years, show me the closure status.
What it can do on your machine
Read from SKILL.md and the folder at commit 19392f7. It shows what the files ask for, not the result of running them.
Tool permissions
Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.
From allowed-tools in the SKILL.md frontmatter.
Runs code
Shell commands in SKILL.md call:
python
From the folder's file list and the shell code blocks in SKILL.md.
Network
No URLs in SKILL.md.
From URLs in SKILL.md, links to its own repository left out.
Credentials
Names no API keys, tokens, secrets or passwords.
From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.
Context cost
Fda Qsr Audit Prep loads about 1.6k tokens when it runs. Until then it costs about 66 tokens; SKILL.md has 456 words of instructions outside code blocks.
Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.
Safety
Auto-check passed
The automated check found no risky patterns in SKILL.md.
Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.
SKILL.md
The full file from alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 456 words, ~1,599 tokens.
Download SKILL.mdSave it as
.claude/skills/fda-qsr-audit-prep/SKILL.md (or your agent's skills folder).- name
- fda-qsr-audit-prep
- description
- /cs:fda-qsr-audit-prep <scope> — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.
/cs:fda-qsr-audit-prep — FDA QSR Forcing Questions
Command: /cs:fda-qsr-audit-prep <scope>
The FDA QSR auditor pressure-tests any US medical-device QSR work. Six questions before any internal audit, FDA inspection, Form 483 response, or recall decision.
When to Run
- Before annual internal QSR audit
- Before pre-FDA-inspection readiness review (any device commercially distributed in US)
- After receiving Form 483 observations
- After Warning Letter receipt
- After MDR-reportable event
- Before recall decision (voluntary vs FDA-initiated)
- Before submitting 510(k) / PMA (where QSR posture affects approval timeline)
The Six QSR Questions
1. Show me the complaint files from the last quarter — and the corresponding MDR reports.
21 CFR 820.198 + 21 CFR 803 — most-cited FDA inspection area.
- Complaint log complete: who / what / when / device / batch
- Investigation closure within reasonable timeline
- MDR-reporting decision tree applied: death OR serious injury OR malfunction-that-could-cause = MDR
- 30-day timeline for most MDR reports; 5 days for certain serious events
- Complaint trending input to management review
2. When was process validation (IQ/OQ/PQ) last revalidated per 21 CFR 820.75?
Cross-walks ISO 13485 Clause 7.5.6 (substantially harmonized post-Feb 2026).
- Initial validation at process introduction
- Revalidation triggers: process / equipment / material change OR periodic schedule
- Statistical techniques per 21 CFR 820.250 where applicable
- Cross-check with cs-cqm-iso13485 for ISO 13485 alignment
3. Show me the DHRs for products commercially distributed in last 2 years.
21 CFR 820.180 — 2-year retention from commercial distribution; check sampling for completeness.
- Device History Record (DHR) for each unit/lot/batch
- Must include: dates of manufacture, quantity manufactured, quantity released, acceptance records, primary identification label, device identification, control number
- Sample stratified by product class
- Verify DHR closeness to DHF (design history file)
Show full SKILL.md (194 more words)Show less
4. Show me CAPAs from the last 6 months with effectiveness verification.
21 CFR 820.100 = ISO 13485 8.5.2 substantially harmonized.
- Root cause analysis depth (5 Why minimum)
- Effectiveness verification = measurable evidence, not "we updated the procedure"
- Containment / correction / corrective action distinction documented
- Closure approval by appropriate authority
- Aging CAPAs > 90 days flagged
5. Show me labeling (21 CFR 801) review for the most recent product launch.
FDA-specific overlay not in ISO 13485.
- Labeling per 21 CFR 801 requirements
- For specific device types: also 21 CFR 800 series sectoral overlays
- UDI (Unique Device Identification) per 21 CFR 830
- Promotional materials reviewed for accuracy + non-misleading
6. If a Form 483 was issued in the last 3 years, show me the closure status.
Form 483 = FDA observation; not equivalent to ISO nonconformity.
- Response within 15 working days
- Each observation has documented corrective + preventive action with timeline
- Effectiveness verification evidence
- For Warning Letters: separate response track + potentially FDA meeting
Workflow
# 1. QSR compliance posture
python ra-qm-team/skills/fda-consultant-specialist/scripts/qsr_compliance_checker.py compliance_state.json
# 2. FDA submission tracking (510(k) / PMA / IDE)
python ra-qm-team/skills/fda-consultant-specialist/scripts/fda_submission_tracker.py submissions.json
# 3. HIPAA overlap (if connected device handles PHI)
python ra-qm-team/skills/fda-consultant-specialist/scripts/hipaa_risk_assessment.py phi_inventory.json
# 4. Mock FDA inspection
python ../../skills/compliance-os/scripts/audit_simulator.py fda_qsr_scope.jsonOutput Format
# FDA QSR Audit Prep: <scope>
**Date:** YYYY-MM-DD
## The Decision Being Made
[programme-plan | inspection-readiness | 483-response | MDR-decision | recall]
## Complaint + MDR Posture
- Complaints last quarter: N
- MDR-reportable events: M
- MDR reports filed within timeline: % (target 100%)
- Complaint trending review at management level: yes/no
## Process Validation Status (21 CFR 820.75)
- Validations on schedule: %
- Stale validations: <list>
- Statistical techniques applied: yes/no per process
## DHR Completeness (21 CFR 820.180)
- DHRs sampled: N
- Completeness rate: %
- 2-year retention compliant: yes/no
- Stratified by product class: yes/no
## CAPA Health (21 CFR 820.100)
- CAPAs sampled: N
- Root cause analysis depth: adequate/inadequate
- Effectiveness verification: complete/incomplete
- Aging CAPAs > 90 days: N
## Labeling (21 CFR 801)
- Recent products reviewed: <list>
- Labeling accurate + non-misleading: yes/no
- UDI compliance per 21 CFR 830: yes/no
## Form 483 / Warning Letter History
- Form 483s last 3 years: N (each: closed/in-progress)
- Warning Letters last 5 years: N (each: closed/in-progress)
- Pattern across observations: <thematic>
## ISO 13485 Cross-Walk (post-Feb 2026 harmonization)
- ISO 13485 audit findings: <link to cs-cqm-iso13485 output>
- FDA-specific overlays remaining: labeling + complaint handling + MDR reporting + recall procedures
- Cross-framework reuse: % of evidence shared
## Verdict
🟢 INSPECTION-READY | 🟡 GAPS-IDENTIFIED | 🔴 NOT-READY
## Top 3 Actions
[3 concrete next steps with owner + FDA-cited timeline (15 days / 30 days / etc.)]
## Outside Counsel Required
[For Warning Letter response, recall decisions, or 510(k) / PMA strategy disputes]Routing
/cs:compliance-readiness— for multi-framework view/cs:iso13485-audit-prep— for ISO 13485 cross-walk pair (substantially harmonized)/cs:gdpr-audit-prep— if connected device handles personal data/cs:gc-review— for Warning Letter response coordination
Related
- Agent:
cs-fda-qsr-auditor - Skill:
fda-consultant-specialist - Adjacent:
../iso13485-audit-prep/,../compliance-readiness/
Version: 1.0.0
© alirezarezvani, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file
Files
Just SKILL.md in compliance-os/skills/fda-qsr-audit-prep of alirezarezvani/claude-skills.
Open the folder on GitHubat commit 19392f7
Compare with similar skills
Fda Qsr Audit Prep next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.
| Skill | Stars | Used in | Tokens | Auto-check | Licence | Repo updated |
|---|---|---|---|---|---|---|
| Fda Qsr Audit Prep this skillalirezarezvani/claude-skills | 28k | — | ~1.6k | Automated safety check: Pass | MIT | |
| Paper to Chinese Patent DrafterYuan1z0825/nature-skills | 47k | 1 repos | ~1.1k | Automated safety check: Pass | Apache-2.0 | |
| C15tc15t/c15t | 1.9k | 1 repos | ~1.6k | Automated safety check: Pass | Apache-2.0 | |
| Contract Reviewevolsb/claude-legal-skill | 464 | 1 repos | ~3.6k | Automated safety check: Pass | MIT | |
| Legal Clinic Client Intakeanthropics/claude-for-legal | 9.6k | 3 repos | ~3.2k | Automated safety check: Pass | Apache-2.0 | |
| Paper To Cn Patentsnipp-zha/Paper-to-patent-Skill | 106 | 1 repos | ~959 | Automated safety check: Pass | None |
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Questions about Fda Qsr Audit Prep
What does Fda Qsr Audit Prep do?
/cs:fda-qsr-audit-prep <scope — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Fda Qsr Audit Prep is an agent skill from alirezarezvani/claude-skills. /cs:fda-qsr-audit-prep <scope — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation.
When should I use Fda Qsr Audit Prep?
Fda Qsr Audit Prep fits situations like: legal & Compliance work in your project.
How do I install Fda Qsr Audit Prep in Claude Code?
Run `npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a claude-code`. Or copy the skill folder (compliance-os/skills/fda-qsr-audit-prep in alirezarezvani/claude-skills) into .claude/skills/fda-qsr-audit-prep in your project. Claude Code loads it when a task matches its description.
How do I install Fda Qsr Audit Prep in Codex?
Run `npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a codex`. Or copy the skill folder (compliance-os/skills/fda-qsr-audit-prep in alirezarezvani/claude-skills) into .agents/skills/fda-qsr-audit-prep in your project. Codex loads it when a task matches its description.
Can I use Fda Qsr Audit Prep in Cursor, Gemini CLI or GitHub Copilot?
Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/fda-qsr-audit-prep, .gemini/skills/fda-qsr-audit-prep, .github/skills/fda-qsr-audit-prep and .opencode/skills/fda-qsr-audit-prep in your project.
What does Fda Qsr Audit Prep need to run?
Going by SKILL.md and its folder, Fda Qsr Audit Prep needs the command-line tools its instructions call (python). Our summary lists: Python 3.
Does Fda Qsr Audit Prep access the network?
SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.
Is Fda Qsr Audit Prep safe to install?
Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.
What licence does Fda Qsr Audit Prep use?
Fda Qsr Audit Prep is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Fda Qsr Audit Prep use?
About 1.6k tokens (SKILL.md is roughly 6.4k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full.
What are the alternatives to Fda Qsr Audit Prep?
Skills that share tags, products or a category with Fda Qsr Audit Prep: Paper to Chinese Patent Drafter (Yuan1z0825/nature-skills, 47k stars), C15t (c15t/c15t, 1.9k stars), Contract Review (evolsb/claude-legal-skill, 464 stars) and Legal Clinic Client Intake (anthropics/claude-for-legal, 9.6k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Fda Qsr Audit Prep?
alirezarezvani (a GitHub user) maintains it in alirezarezvani/claude-skills, which has 27,891 GitHub stars. The repository holds 342 skills in this directory. The repository was last updated on August 30, 2026.
Source: alirezarezvani/claude-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.