build1 publisher
A 90-day inactivity timer closed a CAPA that never got a root cause review
A quality engineer writing on dev.to argues that ISO 13485, EU MDR and FDA guidance all assume an accountable human without listing the approvals an AI may not make, so each site has to write that list itself.
Publishers:dev.to
Reality
- Evidence28
- Adoption18
- Hype gap+12
- Incentives45
- Confidence40