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.
Failure to maintain the integrity and adequacy of the laboratory’s computer systems used by the Quality Control Unit in the analysis and processing of test data. For example a) There was a lack of a secure system to prevent unauthorized entry in restricted data systems. Data edit authorization rights were available to all unauthorized user not only the system administrator.
. Examples include: The system does not generate an
, 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."
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."