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This is regarding the procedure to be followed for archival of raw
data generated by LC-MS/MS output which include but not limited to the
chromatograms, result table, calibration curve, batch sequence, etc.
Is it OK if we convert the above analytical results/data into adobe
acrobat (PDF) first and then take print out? The same PDF files can
then be sent for archival. From a compliance perspective, will that be
acceptable to US FDA?
As per my knowledge and understanding we need to submit all the
original QA reviewed documents for archiving alongwith other project
related files (as well as rejected result files), which are direct
output of a CFR compliant system and not the ones which are PDF
converted as involving more number of software/systems require
additional validation. This is more so, because the activities
performed will be linked through audit trail where each and every
change will be tracked from time to time/as it happens. This may not
remain checked by audit trail once converted to PDF format and chances
of data tempering may be more.
Kindly let me know if anyone is aware about printing analytical data
on PDF first and use of output file for taking print out and
subsequent archival in a GLP compliant system rather than directly
taking the print out of the analytial data as generated by the CFR
compliant software. Kindly share your views.
Thanking you well in advance.
Neel K Mohan
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