FDA observation on IT system controls

                              Observation on IT system controls

Is that companies are not serious about data integrity or users are not trained enough on Data integrity.

Yes, recently FDA has issued a warning letter for pharmaceutical company for multiple observation as follows,

#  Analyst had access to delete and overwrite data

# Over 100 deleted files observed in recycle bin on IR and UV spectrometer computers

# Multiple analytical batch files were deleted

# Unique ID and password for analytical software and generic windows credentials

# Backup practice was not exercised for standalone system

# Failure to trace the previous drug analysis data