dear community members,
I’m very new to this topic and I’m struggling a bit to get the basics.
What I’m trying to achieve in general is to determine, whether a specific sw solution has to fulfill the requirements of p11 in order to enable it’s usage by pharmaceutical industry.
The actual software I’m concerned with is a system managing multicentre studies including collection of imaging data and allowing image analysis on collected data. I’m concerned with p11 as the system is intended to be used also by pharmaceutic companies in their drug research/clinical trials management.
I understand the requirements, but I’m struggling to get the broader picture as to on what software under what circumstances it applies and why is that…
It would help me a lot if someone knowledgeable could point me in the right direction or kindly share a bit of knowlegde here.
thanks a lot, yours,