3 Keys To Meeting Pharma Regulators' Data Expectations

By James Jardine

Regulatory authorities are scrutinizing pharmaceutical companies’ data control practices with more rigor than ever before. The uptick in data integrity reprimands shouldn’t come as a surprise to anyone in the pharma industry, given regulators’ continually increasing (and well-warranted) concerns about data management matters in general. The FDA and other regulatory agencies around the world will continue to ramp up their prioritization of issues recognized as being related to data control.

The systems, processes, and personnel that pharma organizations rely on to manage quality are only as effective as the usefulness of the data with which they’re provided. In other words, only accurate data translates to meaningful outcomes. To improve the actionability of data, pharma organizations can take the following three fundamental steps that will enhance their ability to leverage it to achieve quality and compliance goals.