FMEA
International
Clinical and safety methodology
Failure mode and effects analysis
Proactive analysis of how a process could fail, before it does. The counterpart to root cause analysis, which only ever runs after the event.
What we claim, precisely
The platform holds this standard down to the measurable element, with an owner, a control and live-linked evidence for each one, and reports readiness and gaps. It does not assert that a facility is compliant. A person signs that off.
Preparing for FMEA
Open the sandbox and look at the readiness view, or ask us to walk it against your own standard set.