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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2016)

Data Integrity in The Life Science Industry

Prachetas Mehta

Introduction: As industries are turning towards Industry 4.0 and Big Data, digitization and automation is an obligatory part of the industry. And digitization or automation creates huge amounts of information or raw data, which needs to be handled properly and filtered to convert it in to “Useful Information” or “Intended Data”. A cell wise structure of any industry is a machine which generates a pool of data and same will be transferred and stored and organized to meet specific requirements.
As per USFDA guidelines, Data Integrity refers to the completeness, consistency and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA).
 

 

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