FDA QSIT - Quality System Inspection Technique
FDA QSIT (Quality System Inspection Technique) is the name of the document that provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer's compliance with quality system regulations.
An FDA QSIT inspection is a "top-down" inspection (vs. a "bottom-up" inspection) and rather than focusing on many minor deviations, it focuses on systemic issues that can primarily be detected within quality-related documentation and subsequent document sampling.
Free Resources
