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Frequently Asked Questions

Who is in charge of inspection readiness tools?

Many companies adopted the use of Inspection Readiness Tools as part of their IR processes. IR tools should undergo a regular review of the for accuracy and completion. Clinical Operation group should be in charge of maintaining those tools. IR tools have two primary objectives:

Is your Pharma organization inspection ready?

Inspection Readiness Tools Every pharma organization should be inspection ready at all times. Day one of IR starts with first clinical protocol finalized and continues through finalization of the clinical study report. Many companies adopted the use of Inspection Readiness Tools as part of their IR processes.

What is the difference between inspection readiness and inspection preparation?

Inspection Readiness: to increases awareness of areas that can be covered during inspections and to consider implementation at early stages. Inspection Preparation: To facilitate inspection preparation upon submission or following inspection announcement.

Are you prepared for FDA inspection readiness?

Ensuring FDA inspection readiness at all your suppliers’ facilities won’t only help you prepare for an official FDA inspection. It will also help you protect your customers from potentially unsafe products. The first step to ensuring FDA inspection readiness is to familiarize yourself with the various types of inspections.


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