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.
Posted by Dr. Tim Sandle
