What is a QSIT audit?

QSIT is an inspection process based on the subsystems of the quality system. To improve the efficiency of the inspection process, the QSIT approach focuses on the four primary subsystems: management controls, design controls, corrective and preventive actions, and production and process controls.

What are the 4 QSIT controls?

To improve the efficiency of the inspection process, the QSIT approach focuses on the four primary subsystems: management controls, design controls, corrective and preventive actions, and production and process controls.

Which systems are part of the QSIT Quality System inspection Technique Handbook?

QSR subsystems: A QSIT inspection focuses on 4 major subsystems of the Quality System that establish the basis for what FDA inspectors will review: (1) Management Controls, (2) CAPA, (3) Design Controls and (4) Production and Process Controls.

What does QSIT stand for in quality system inspection?

“Quality System Inspection Technique” or “QSIT”. Field investigators may conduct an ef- ficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm’s quality system. Note: This manual is reference material for investi- gators and other FDA personnel. The document does

Why is the QSIT important to the FDA?

The QSIT approach to FDA Inspections embraces a top-down inspection of a firm’s Quality Management System, and is therefore, a valuable tool to personnel responsible for compliance, legal, management, quality, regulatory, and technical personnel who directly interface with FDA during inspections.

What is the new quality system inspection technique?

new inspectional process is known as the “Quality System Inspection Technique” or “QSIT”. Field investigators may conduct an ef- ficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm’s quality system. Note: This manual is reference material for investi-

What are the different types of QSIT for medical devices?

FDA’s Medical Device Quality System Inspection Types Abbreviated QSIT – Two subsystems; Corrective and Preventive Actions (CAPA) plus Production and Process Controls (P&PC) or Design Controls Comprehensive QSIT – The four major subsystems; Management Controls, Design Controls, CAPA and P&PC