Individual skill

fda-qsr-audit-prep

FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed.

ra-qm-team/audit-prep/fda-qsr-audit-prep/SKILL.md

Source commit 25bf86b89c6c1e63f433a5b65e8cfcb6cf0b7ad3

What was checked

Matches the observed repository HEAD

Yes

Scanner rules are current

Yes

Repository scan complete

No

Skill scan complete

No

Observed behavior

Network or broad shell

Last checked

Nov 10, 2026

These are observations at the recorded commit, not a guarantee of safety. Review the source before running it.

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