Do you have difficulties finding stuff to insert into the PQ protocol
for a basic data entry software system. Before inserting a new
software into production we do a supplier Audit, DQ, FAT’s and then
a “User acceptance test” then we follow it all with a IQ, OQ and PQ.
The problem I am having is that by the time we get to the PQ all the
software has been tested, all the SOPS have been written tested and
authorised, everyone has been trained and all the documentation is
Hence I am having trouble finding things to insert into the PQ which
hasn’t already been thoroughly tested. The normal V shaped diagram
where "Design=IQ, “Functional Spec = OQ” and “URS = PQ” doesn’t
always work. To test the functions properly in the OQ you basically
have to simulate the user process and therefore for most software
systems you are also testing all the User requirements.
Obviously for systems which control a production process or have lots
of workflow then a PQ is a must, but for a normal data entry system
everything is thoroughly tested in IQ and OQ. So if we don’t want a
one page PQ we basically have to repeat the tests which were already
in the OQ.
To stay on topic lets take the Part 11 part of the software.
Once I have tested that the software conforms and performs
That all the policies and SOPS have been written, tested and
That all the users have been trained
Then what tests would I put in the PQ which weren’t already in the
OQ. Besides checking that the users are following the SOPS and
policies correctly, etc which are normally tested with internal
Any thoughts OPQ maybe?