PQ parameters for computer system validation of configurable software of laboratory equipment

[v9991]

Background.,
we are challenging the following parameters for software validations ( cat-4 - configured s/w )
IQ - installation and initialization of the software for the readiness of operations. ( viz., pre requisites of OS,
OQ - configuration, privileges / access-rights, audit trail, backup - archival - restoration, errors/warnings,
PQ - number of systems for simultaneous operations, extent/length of the runs to handle the maximum amount of specified data.

For instruments part of it ,the qualification includes, ,
IQ is with integration / commissioning /traceability of the equipment's parts - models.
OQ covers - operating ranges of the equipment; and some self-health-check packages.
PQ - calibration and operating parameters.

Following scenarios, is where CSV is carried out separately ( for retrospectively or for legacy system or CSV is performed in sequence after instrument commissioning & qualification)

View :-as part of CSV, for PQ, we need to separately-establish the sample/material analysis ( in addition to the PQ performed for equipment performance) (this will establish the correct working of the software, and software controlling - measuring - processing - reporting data)

Counterview :- PQ of the equipment performance inherently covers the software PQ as well; is covered as part of the IQ-OQ-PQ of techno-functional aspects of the software. ( because, as part of the data review for the instrument PQ data, which involves the data review - audit trail review - etc which essentially ensures the software part of the method - integration - results and files are verified correctly prior to sign off the instrument qualification )

your thoughts and guidance please

 

[v9991]

Background.,
we are challenging the following parameters for software validations ( cat-4 - configured s/w )
IQ - installation and initialization of the software for the readiness of operations. ( viz., pre requisites of OS,
OQ - configuration, privileges / access-rights, audit trail, backup - archival - restoration, errors/warnings,
PQ - number of systems for simultaneous operations, extent/length of the runs to handle the maximum amount of specified data.

For instruments part of it ,the qualification includes, ,
IQ is with integration / commissioning /traceability of the equipment's parts - models.
OQ covers - operating ranges of the equipment; and some self-health-check packages.
PQ - calibration and operating parameters.

Following scenarios, is where CSV is carried out separately ( for retrospectively or for legacy system or CSV is performed in sequence after instrument commissioning & qualification)

View :-as part of CSV, for PQ, we need to separately-establish the sample/material analysis ( in addition to the PQ performed for equipment performance) (this will establish the correct working of the software, and software controlling - measuring - processing - reporting data)

Counterview :- PQ of the equipment performance inherently covers the software PQ as well; is covered as part of the IQ-OQ-PQ of techno-functional aspects of the software. ( because, as part of the data review for the instrument PQ data, which involves the data review - audit trail review - etc which essentially ensures the software part of the method - integration - results and files are verified correctly prior to sign off the instrument qualification )

your thoughts and guidance please

to summarize my previous predicament,
option-01 whether it is allowed to use the instrument PQ runs as support for the PQ for the CSV criteria?
my proposition was yes, it can be used;
and counter proposition was no, it has to be repeated.,

there is an extension of same scenario, at a validation plan for qualification equipment.
option 01 - software qualification would start after completion of instrument qualification ( at least IQ and OQ )
option 02 - software qualification would follow parallel to instrument qualification ( viz., IQ ( Instrument -> software ); OQ ( Software -> instrument) and PQ ( software & instrument )