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Hussain: Empowering Workers is the Key to Data Integrity

This article was originally published in The Gold Sheet

Executive Summary

Why would pharmaceutical quality personnel fib about something like a batch test? Ajaz Hussain, the former FDA’er who helped launch the 21st Century Quality Paradigm, may have found the answer in the science of human behavioral economics.

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Confronting Illusions of Quality in Indian Generics Manufacturing

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Thakur: Data Integrity Requires Stronger Local Enforcement

There is a better answer to India’s data integrity crisis than putting 19 American inspectors there to enforce U.S. standards in country of a billion people. India’s own inspectorate needs to step up its game, says Dinesh Thakur, who nine years ago first alerted FDA to the problems at one firm, Ranbaxy.

Cahilly: Focus on India Masks the Real Data Integrity Problems

The problem of data integrity is not so much with a supplier or contract manufacturer halfway around the world, says Monica Cahilly. It’s more about that pdf you just printed from your electronic information system.

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