Are you all using the “Administrator” password?
A company recently received this 483 observation:
….Computerized systems do not have sufficient controls to prevent unauthorized access or changes to data.
Specifically, unique user identifications have not been established for computerized systems used in the QC Laboratory. All personnel share the “Administrator” user name and password to log into and perform commercial release testing using chromatographic instrumentation. Furthermore, the “Administrator” user has unrestricted system and software privileges that allow for the deletion, modification and alteration of raw chromatographic data.
For more observations pertaining to Data Integrity, as well as Manufacturing Controls, Laboratory Controls and Medical Device Manufacturing Controls, see Issue 1012 available today.