Guide to Inspections of Quality Systems
Faced with an increasing backlog and lengthening inspection times the FDA publishes a guidance document to its field staff on a new inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation and related regulations. The Quality System Inspection Technique (QSIT) was developed to enable field investigators to conduct an efficient and effective comprehensive inspection which would help them focus on key elements of a firm's quality system.