Follow
The regulatory agency FDA has recently issued a warning letter, highlighting these data security issues. Several causes contribute to this data integrity problem.
=>> Colony-forming units are miscounted when counting plates.
=>> The sample is moved like an environmental study sample, not taken or dropped anywhere, such as in transit or an incubator.
=>> Finger touches are not taken correctly when a staff member leaves an aseptic processing area.
=>> No reconciliation of paperwork and samples.
=>> Not recording a cleaning or disinfection session.
=>> One worksheet is torn up and the results are rewritten on a second sheet.
=>> Lack of reconciliation of printed forms.
=>> A problem with computer systems.
=>> Out-of-limits results are not being investigated.
=>> A typical organism recorded by microbial identification or the organism does not match the colonial description.
=>> Evidence of microbial identifications that are rerun for a better result.
