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Interesting article about the focus on "Data Integrity" by the FDA by Barbar Unger, Unger Consulting, in BioProcess Online.  Read the full article HERE.


Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions.

The FDA initiated enforcement actions in this area as early as 1999 and continued to the point where the last three years have seen data integrity cited in 68 to 80 percent of warning letters. We have seen ever-increasing participation by global health authorities.

Executive Management Ownership

  • Executive management must understand that health authority focus on this area is not going to diminish. Data governance applies to both paper and electronic data throughout its life cycle.
  • Executive management must establish and maintain a corporate culture of openness where employees may report problems and failures without fear of retribution. In fact, reporting of problems should be encouraged and rewarded.
  • Executive management must own the gap assessment process and remediation efforts. Remediation may be costly and time-consuming. Firms often uncover additional problems along the way. Don’t expect to complete remediation quickly; it’s often a multiyear process.