Fda Qsr Audit Prep

Fda Qsr Audit Prep

/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.

Optimized workflow

This edition turns the source methodology into a repeatable agent workflow with explicit inputs, checkpoints and deliverables.

Quality standard

• Confirm scope and missing inputs before execution
• Ground decisions in available evidence and preserve source constraints
• Return an actionable result with assumptions, risks and next steps

Agent compatibility

The same core method is packaged for Claude, Codex, GPT, Gemini, Cursor and OpenCode.