Free Download — No Credit Card Required
The CAPA Master Toolkit
The complete corrective action system FDA investigators actually reference during 483 reviews.
Used by quality teams at 200+ FDA-regulated device manufacturers.
What's inside (8 documents):
- ✓ CAPA Master SOP — 21 CFR 820.100 compliant, FDA-reviewer language throughout
- ✓ Root Cause Investigation Worksheet — fishbone + 5-why integrated, 483-response ready
- ✓ CAPA Effectiveness Check Template — closes the loop auditors look for
- ✓ CAPA Risk Classification Matrix — determines response urgency per severity
- ✓ FDA 483 Response Letter Template — used by RA directors for observation responses
- ✓ CAPA Trending Dashboard — monthly/quarterly trend tracking for management review
- ✓ Training Record Template — documents CAPA-related training completion
- ✓ CAPA Log Master Tracker — complete open/closed CAPA tracking spreadsheet
“Our last FDA inspection, the investigator asked specifically about our CAPA effectiveness checks. We had them. She moved on.”— D.M., VP Quality, Class II device manufacturer
“I've seen the FDA CAPA guidance. This toolkit implements it correctly.”— R.S., RA Director, IVD startup
RegWatch Daily · regwatchdaily.com · No spam. Unsubscribe anytime.