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Empower 3 validation
Posted: Thu Nov 03, 2011 4:10 pm
by leonvdbos
We have bought two UPLC systems connected to Empower 3 software which is locally installed on a PC
We want to validate the software. What should we validate?
Re: Empower 3 validation
Posted: Fri Nov 04, 2011 5:29 pm
by DR
I'd start with the qualifications of all who will design, execute and sign off on the validation protocol...
Seriously, if you don't know, it would probably be best to have the vendor perform initial I/O/PQs for the system after your internal QA department has had a chance to review, understand and specify a set of system policy options they want switched "on".
Re: Empower 3 validation
Posted: Mon Nov 07, 2011 12:57 pm
by R13
You do not have a chance to do it by Yourself.
It is done like this. Software supplier provides:
-certificate about GMP/GLP compliance during development and "production",
-procedures to check correct installation and software integrity at which point system is declared validated,
-procedures to check later that software is still working correctly.
User can later run periodical check that software is not cmpromised and working properly. Usually this involves checks in security policies (logins, restricted access), data protection and integrity (raw data can not be changed) and correct integration of "certificate" chromatogram.