I am new to this site
I have been getting so much knowledge from this askaboutvalidation website since last four months.
The first and best site introduced on overview of GAMP4 guidelines with detailed and simple presentation.
Can Anyone validated OPM(Oracle Process Manufacturing) E-Bussiness Suite software for any organization.
if so Please share your experiences with me.
This software is USA based, well structured and full version control with beautiful documentaton.
My first question on this software is whether the functional specification and design qualification is required for this software or not.
Can we considered this software as standard software package or not?
Whether Full validation life cylce is required for this standard software packages or not