Data Integrity And Data Management For GxP Regulated Firms — Part 1
Data Integrity And Data Management For GxP Regulated Firms — Part 1

This article series intendeds to remove some of the mystery surrounding the topic and to provide readers a broad background on data management and data integrity — as well as suggestions for how they might begin to address this issue within their company.

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    AstraZeneca is a global, science-led biopharmaceutical business. They are one of a handful of companies to span the entire life cycle of a medicine – from research and development to manufacturing and supply – as well as the global commercialization of primary care and specialty care medicines. Operating in more than 100 countries, AstraZeneca employs around 57,500 people worldwide. The company has manufacturing operations in 17 countries, and their innovative medicines are used by millions of patients worldwide.

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    Three years into a U.S. initiative for drug “serialization,” companies are: (a) working with the FDA; (b) taking their own steps to traceability; and/or (c) hoping the day of reckoning fades further into the future. But the future is here with serialization reaching into the consumer’s home. 

  • Is Marketing Manipulating Your CMO Selection?
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