Prepare FDA 21 CFR 820 QSR audit
fda-qsr-audit-prepskillsetup L1★17,464
alirezarezvani/claude-skills ↗What it does
Pressure-test FDA QSR (21 CFR 820) compliance with six forcing questions
Best for
When you need to audit medical device QSR posture before internal review, FDA inspection, or Form 483 response.
Inputs
- · scope (audit|inspection|form-483|recall)
- · complaint files
- · process validation records
Outputs
- · QSR posture (green|yellow|red)
- · gap list
- · top 3 action items
Requires
- · complaint tracking system
- · DHR archive
- · CAPA database
Preconditions
- · QSR documentation accessible
- · complaint logs available
Failure modes
- · Stale complaint data
- · incomplete DHRs
- · missing CAPA effectiveness evidence
Trust signals
- · 21 CFR citations
- · ISO 13485 harmonization cross-check
- · external counsel triggers defined