The benefits of Mock Inspections in Pharma Industry

 

Data Integrity App

Mock inspections are a good way for your organization to provide a training experience that approximates the intensity of a real inspection.

In essence, a mock FDA inspection is a role-play that casts an individual in the role of an FDA investigator who conducts an inspection “in character” and helps the organization live through a simulated FDA inspection.

 

This type of experience is valuable for a number of reasons. It allows you to test your “inspections SOP” under realistic conditions and to determine whether it covers the process completely and provides the guidance people need to respond to the situation quickly and appropriately.

 

It also gives you the opportunity to analyze your logistic capabilities, corporate procedures, and information systems to determine whether they can handle the documentation and data demands of an inspection in a timely fashion. 

As a result, you can identify and correct weaknesses and can enhance your systems and procedures before their shortcomings inflict damage on your organization.

Another important benefit of mock inspections is their ability to make the inspection process more real to those who have never participated in one. With the experience of mock inspections, your employees will have a much better idea about the types of questions they might be asked, what role they should play, and how they should react in various situations.

“Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App

 Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 

Data Integrity App Link:

https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.