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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2016)

FDA Expectations on Data Integrity

Mayank Anand

Introduction: Currently the world is data driven. The integrity of data is very crucial from FDA point of view. As per many regulatory bodies data integrity is the degree to which re-coded data is complete, consistent and accurate throughout its lifecycle. As per FDA, EMA TGA and MHRA data manipulations, misrepresentation, tampering, unwarranted deletions/extensions and concealing are serious offence. In the last few years, FDA has issued warning letters and import alert to hundreds of companies in India and abroad. FDA expects that all data generated at the site must pass data integrity criteria as laid down in the official guidelines. It further requires that the data shall be recorded as the job is performed and original/certified copy of the same shall be maintained over its life cycle. FDA has turned very strict about meta-data i.e. date, time; author, subject associated with principle data sets. 

 

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