Agenda for Your next Pharmaceutical Inspection

 

Data Integrity App

Inspection Agenda:

 Looking at some crucial points that ensure data integrity, it quickly becomes clear that this is not a new element of inspection.

 

Inspection Agenda includes the following inspection tools:

·         ALCOA principle

·         Audit trail

·         Data review

·         File format

·         Storage media

·         Encryption

·         User management (Access Control)

·         Review of the data life cycle

·         Handling of raw data

 

These points have always been part of the inspection's agenda.

Subsequently in can be said that data integrity is not only an IT topic; it includes all areas of the documentation.

The requirement that every change to a document has to be initialed and dated and that the original information has to stay legible despite all changes, is of essential importance for paper documentation as well as electronic documentation.

 

For electronic documents, this should basically be implemented through validated audit trail functionality. Many companies are still struggling with this, particularly as there aren't any acceptable systems available, sometimes.

 

“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.