Data integrity is a major concern in the regulated pharmaceutical industry due to discovery of either poor record management practices or falsification of data. In this article, data integrity ...

Master Data Management (MDM) is the technology approach to solving this pain. Business professionals have the knowledge of the market needs and competitive landscape that many IT folks don't have.

Together, these principles ensure smart meters can withstand evolving threats while maintaining compliance and operational reliability. Organizational readiness for secure smart m ...

Resolution of regulatory issues: BioXcel is currently conducting an internal investigation and has commissioned an independent audit of the trial data.

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.

"Improving data quality/information integrity" retained its position as the most pervasive critical technology concern among CFOs (according to 42 percent of respondents) in the 10th annual ...

According to the Food and Drug Administration (FDA), AveXis Inc, the manufacturer of the gene therapy Zolgensma, was aware of an issue related to “data manipulation” prior to approval, but did ...