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Preparing for Your FDA Inspection

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QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)

If you are new to the whole FDA inspection system or if you've been away from the process for some time - you should take some time to familiarize yourself with the Agencies procedures. When they come - FDA field staff may use the method known as the Quality System Inspection Technique (QSIT) to evaluate your compliance to the Quality System Regulation (QSR).  QSIT allows the investigator to focus on particular elements of your quality system making for a comprehensive overview.  There is a definite benefit when you know ahead of time what the questions are going to be!  Unfortunately, many organizations do not take the time ahead of time to prepare for the questions.

How does preparing help?

Knowing what questions will be asked allows you to prepare the response ahead of time.  You can collect the necessary documents and present them to the auditor in a timely and efficient manner.  Some people being audited may think this is a negative thing.  They think erroneously that presenting information too quickly allows the inspector to look at more documentation.  This is false.  What it does accomplish is an overall impression that the firm is in control of their processes and more importantly in compliance with FDA's QSR. Taking too long to obtain requested information can frustrate the FDA inspector and may lead her to think that you are trying to intentionally suppress the information.

Preparing in advance and knowing what questions the auditor is going to ask also helps alleviate some of the stress associated with anticipation. It really is fear of the unknown.  If however you take the time to go over the QSIT questions and construct the associated answers you will find that you don't feel as stressed.  And of course you will feel more confident in yourself and this will definitely be conveyed to your auditor.

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