Dirkjan: Created page with "The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer'..."

2020-08-25T07:19:52Z

Created page with "The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer'..."

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The Quality System Inspection Technique (QSIT) provides guidance to the FDA 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. Field investigators may conduct an efficient and effective comprehensive inspection using this guidance material which will help them focus on key elements of a firm's quality system.

The QSIT involves four [[Top-Down Inspection|Top-Down Inspection]]'s of the four major subsystems of the quality system:
* [[Manufacturing Controls|Manufacturing Controls]]
* [[Design Controls|Design Controls]]
* [[Corrective and Preventive actions|Corrective and Preventive actions]]
* [[Production and Process Controls|Production and Process Controls]]

The QSIT (Quality System Inspection Technique) Handbook (copy available

<html><a href="/static/files/FDA/QSIT_Inspection_handbook.pdf">here</a></html>

) is used to train FDA inspectiors in this technique.

Find the FDA description [[http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm|here]]
[[Category:fda]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:QSIT]]

[[Category:Quality System Requirements]]

[[Category:Term]]

Quality System Inspection Technique - Revision history

Dirkjan: Created page with "The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer'..."