Three Key Sources of Data-Related Compliance Risk (And How to Fix Them)

Navigant experts Colleen Hittle, Stephanie Lewko, and Jim Williams examine the challenges life sciences companies face when storing, updating, and analyzing critical compliance-related data. Many companies store data in outdated computer systems, which often are spread across various geographies and don’t adhere to the same formatting standards. Colleen, Stephanie, and Jim advise how to properly analyze the data.

Article Excerpt: 

Current FDA and U.S. Department of Justice (DOJ) compliance trends reinforce that a company’s ability to accurately and quickly gather, analyze, and manipulate data is the key to avoiding enforcement actions.

Three particular areas of risk highlight the importance of maintaining validated compliance-related data in appropriately designed and controlled systems:

  • FDA’s Unique Device Identifier (UDI) Final Rule
  • DOJ Foreign Corrupt Practices Act (FCPA) investigations
  • FDA’s requirement that manufacturers submit new 510(k)s for already-cleared products that have been changed
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