CAPA
Also called: Corrective and preventive action
The actions taken to fix the cause of a quality problem and stop it, or similar problems, from happening again.
CAPAs come out of deviations, complaints, audits and trends, and each has an owner, a due date and a check that it worked. ICH Q10 names the CAPA system as one of the core elements of a pharmaceutical quality system.
CAPAs that depend on a partner are the ones that stall.
Where it goes wrong
A partner’s promised action, made in an audit close-out email, goes quiet and comes back as a repeat finding.
What Spurby does
Takes commitments from emails and minutes, watches for delivery, and drafts the follow-up when one goes quiet.
Spurby for pharmaOn our roadmap