Software Development
FDA QSR Audit Prep
/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.
- Publisher / source
- Claude Skills Collection
- Upstream record
- alirezarezvani/claude-skills
- Version
- Version 3
- Published
- Publication review
- Approved for publication
- Content fingerprint
d0fc093538f3486ba1471f9674789ec0930bc2c235059378b8ec8b061c519486