Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistAll AssessmentsReadiness Assessment, 8 Questions, About 7 Minutes
CAPA & Investigations
CAPA and investigation failures are among the most-cited areas in FDA enforcement, the single most-cited on device 483s, and a top driver on drug-CGMP inspections. Rate your program honestly across eight dimensions.
How thoroughly do investigations reach true root cause?
Do investigations stop at the symptom, or reach a verified root cause with a defined methodology?
What FDA inspects: corrective & preventive action. See the trend