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Data Integrity App

A designated secure area or facility (e.g. cabinet, room, building or computerized system) for the long term, permanent retention of complete data and relevant metadata in its final form for the purposes of reconstruction of the process or activity.
 
All over the pharmaceutical industry, both businesses and patients depend heavily on the integrity and confidentiality of archived records. In the highly regulated world of drug manufacturers, properly preserving documentation is a critical requirement for business continuity.

Archived records may be the original record or a ‘true copy’ and should be protected so they cannot be altered or deleted without detection and protected against any accidental damage such as fire or pest.   

Archive arrangements must be designed to permit recovery and readability of the data and metadata throughout the required retention period. 

In the case of archiving of electronic data, this process should be validated, and in the case of legacy systems the ability to review data periodically verified (i.e. to confirm the continued support of legacy computerized systems).


“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.


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