fda-qsr-audit-prep

Name: fda-qsr-audit-prep
Author: alirezarezvani

alirezarezvani/claude-skills/compliance-os/skills/fda-qsr-audit-prep

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/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.

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