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