FDA Inspection Observations

What problems are health authorities observing during their inspections?  Health authorities are seeing a wide variety of different types of data integrity issues at facilities throughout the world, including but not limited to the following examples:

  • Failure to record activities contemporaneously (this could be documenting the event before it happens or documenting the event several days later)
  • Falsifying or making up data
  • Copying existing results as new data
  • Retesting samples without justification or an investigation
  • Deleting data
  • Releasing product with out of specification results
  • Not saving electronic data
  • Not having appropriate user levels for electronic systems
  • Or users with interest in the data having system administrator access