Warning Letter: Deviations from Part 11 (m2811n)

Tags:

Ofni Systems
 
"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."

View the original warning letter.


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