Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain a viable business. More specifically, these trends have raised the profile of Data Integrity (“DI”).
Overview: The Importance of Data Integrity to the C-Suite
1. The cost of reactive regulatory compliance is daunting, and erodes credibility with customers, employees, reduces time to market and limits future strategic options.
2. The risks of non-compliance increase with the number of NDAs/ANDAs and facilities, as increased scrutiny comes with scale, and regulatory authorities are willing to send warnings to multiple sites based on the review of one site.
3. A pharmaceutical manufacturer’s #1 lever to pull to reduce risk of regulatory action is in improving Data Integrity. Doing so may provide a sustainable advantage in a highly competitive market.