Empower 3 validation

[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?

[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".

[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.