Suzanne
I have come across a number of monitoring devices that possess the
capability to reprint a record if the paper snags. Examples being older
chromatographic integrators, stand alone particle monitors, thermal data
loggers, chart recorders, plate readers, etc. More often than not, this
record is overwritten at some non configurable point in the future and the
user can not prevent this from occurring, nor can they modify the contents
of the record.
If the device does not perform any reprocessing of the data when the record
is reprinted following a paper snag, but merely produces a further copy of
the report and if there is no way in which the report can be modified. Then
I ask what is the issue???
Now, if the report was regenerated by reprocessing the data and it was
possible that the results reported could be modified by altering a method
or
sample parameter prior to reprocessing then I can appreciate the part 11
may
apply.
I seem to recall that this issue has been discussed previously with regard
to data loggers and the comment was that there are far more opportunities
to
interfere with the integrity of the record by way of inappropriate use of
the instrument than by fiddling with the report. Does making a system that
transiently stores information complaint with part 11 make any sense,
because once in a blue moon the paper snags ???
Regards Allan Taylor
My opinions do not necessarily reflect those of my employer.
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