The drug industry’s data integrity problem | January 8, 2018 Issue - Vol. 96 Issue 2 | Chemical & Engineering News
Volume 96 Issue 2 | pp. 15-17
Issue Date: January 8, 2018

The drug industry’s data integrity problem

A spike in FDA letters citing inadequate data quality at drug plants puts the spotlight on software—and the people who use it
Department: Business
Keywords: Informatics, quality, FDA

As emphasis grows on managing data in pharmaceutical labs and plants—collecting and storing it, sharing it, mining it for pertinence—a basic question often goes unanswered: Is the data any good?

The quality and completeness of data associated with making drugs are, however, huge concerns at agencies such as the U.S. Food & Drug Administration. And drug companies are being forced to pay attention to data in response to a sharp increase in the number . . .

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