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