Analysis Of FDA Warning Letters

Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. This is the focus of a review of FDA warning letters and data integrity concerns, conducted by Barbara Unger, Unger Consulting Inc., for Pharmaceutical Online.

Here is an extract:

Failures in data governance and data integrity continue to be addressed in approximately 80 percent of FDA warning letters issued to both domestic and foreign sites. Requirements in this area apply to both paper records and electronic records. Warning letters continue to cite similar deficiencies to those identified between 1999 and 2006, including computer systems not validated for their intended purpose, lack of controls over computerized systems to prevent access by unauthorized users, and failure to evaluate all original data (including audit trails) generated in testing and to consider the results as part of the lot release decisions.

To access the article, see Pharmaceutical Online.



Posted by Dr. Tim Sandle