Computer Systems Not Maintain


Warning Letter: Failure to maintain original data (m3847n)

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Failure to maintain complete data from all laboratory tests as required by 21 CFR 211.94 (a). There is no back-up file for laboratory UV spectrophotometer test results for some tests. The spectrophotometer does not automatically back-up data and the analyst is required to assign an identification number to each individual chromatogram in order for it to be saved. In some cases, original data was lost and the tests had to be performed again to determine final distribution of the lots.

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Warning Letter: Deviations from Part 11 (m2811n)

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"our inspection disclosed numerous and
significant deviations from part 11
. Examples include: The system does not generate an
audit trail
, and there is no way to determine if values have been changed on batch production records. This is important because an audit trail can be the only
evidence that an electronic record has been altered
. We note, for instance, that your system only records the last value entered by an operator and that values, such as Oxygen potency levels that my have been entered earlier and that may indicate potentially serious quality problems, are not recorded. The system prompts an operator when equipment detects that an Oxygen potency value is non-conforming, and permits the operator to record a value that is within specification, but does not record the original out of specification value."

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Warning Letter: Improper maintenance of electronic records (m2819n)

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"Failure to
maintain laboratory records
to include complete data derived from all tests necessary to
assure compliance with established specifications
and standards [2 1 CFR 211. 194]. Specifically, your firm failed to properly maintain electronic files containing data secured in the course of tests from 20 HPLCS and 3 GLCS. Additionally, no investigation was conducted by your company to determine the cause of missing data and no corrective measures were implemented to prevent the recurrence of this event."

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