Process
Page 22 of 60
M1393R0
OQ/PQ Operating Instructions
3.4
Evaluating the Tests
The templates provided with CD ROM ‘IQOQPQ on UltiMate
™
(Plus) systems’ and thus, all
copies made from it for OQ and PQ are linked to the corresponding report. Do not change
this report (except for items that are described in
S
ection 4.14). In the report, many
references link the separate data sheets. When lines or columns are inserted or deleted,
the references are lost and thus, the calculations will be wrong!
To ensure that the data are correctly read and processed in the report, print the report as
‘Batch Report’ from the Browser. Select the sequence for which you want to print the
report. Verify that ‘no sample’ is selected! Select ‘Batch Report’ on the ‘File’ menu and
start printing by clicking ‘OK’. )
For the system tests 4.3, 4.6, 4.7, 4.8, 4.9, 4.10 and 4.11 the pump- and (trap) column-
pressure data is saved. These traces can be opened and reviewed from the CHROMELEON
program.
For the tests 4.7, 4.8 and 4.9 it is essential to check the integration carefully. Manual
integration of peaks may be required.
3.4.1
Repeating Tests
It may be necessary to repeat one or several tests. In this case, refer to Chapter 5
(Troubleshooting). This chapter describes problems due to which a check may have failed.
According to GLP, a test which failed and all tests following the one which failed need to
be repeated. Exception: there is no need to repeat UltiMate and FAMOS related tests if a
Switchos test fails. The reason is that almost all checks require that the previous check be
passed successfully. Example: If the UV detector linearity check fails, the results regarding
the linearity of the injection volume are questionable because the detector linearity
detector is a basic requirement for checking the injection volume.
