White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

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.

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