fda-qsr-audit-prep
From the author
/compliance-os: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.
Install
npx skills add alirezarezvani/claude-skills --skill fda-qsr-audit-prep -a claude-code
Installs to .claude/skills/fda-qsr-audit-prep/ · Each command fetches the skill straight from GitHub with the open skills CLI.
Byte-identical to the scanned commit, with the repository’s licence and a SOURCE.txt.
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