| |December 20208LEVERAGING IT TO ENSURE DATA INTEGRITY IN PHARMACEUTICALDeepak Saini has incomparable experience in IT Strategy, Solution Architecture, and Right Fit IT Solution. He is a prolific collaborator and dedicated IT professional.I ndian pharma generics compa-nies account for around 30 per-cent (by volume) and about 10 percent (value) in the US$ 70-80 billion US generics market. In the last two years, a large percentage of warning letters of all the FDA's warning letters were issued to worldwide phar-maceuticals companies for failing to meet da-ta-integrity standards. Data Integrity issues can put a brake on all growth engines of a phar-maceutical company. Any serious violation concerning data integrity may lead to severe regulatory actions like the ban on drug export or delay in approval to ANDAs.Regulatory agencies are also evolving the new ways to test the data in pharmaceuticals against all requirements which are neces-sary to keep the integrity of data 100% intact. In the last couple of years, the Indian phar-ma companies have faced a lot of challenges with the US FDA due to data integrity issues in their environment.The top management of all pharma compa-nies in India shall build and cultivate a strong culture of data integrity. The culture of the company should help employees to understand the impact of data integrity issues on company operations, damage to reputation, differences between "errors" and "falsification' etc.The IT Team can play a vital role in ensur-ing 100% data integrity by helping employees to understand the complete data lifecycle, dis-covering all leak points which offers possible falsification/manipulation/change in data and By Deepak Saini, Director ­ IT, Dr. Reddys Pharmaceuticals LLC, NAG Regioncontrolling them by implementing the right set of custom and off the shelves IT tools and applications.Ensuring Integrity in Data LifecycleIt is very important to understand the complete life cycle of data in pharmaceuticals. Data in no stage should be left orphaned. It should always be under monitoring of an electronic surveillance ecosystem. The sophisticated IT tools should be implemented and shall record each event happening on a set of data. Who, what, when and why hap-pening on data shall be recorded without fail. The crux of validation of data life cycle in pharmaceuticals revolves around one equation which is "The authentic validated Deepak Sainiexpert opinion
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