2 of 2 people found this helpful
Do you have specific questions on setting up the environment in terms of reporting regulations and IT concerns? The two good resources I would recommend to you are:
- Using the ISRA Life Sciences Reference Architecture white paper which can be found on our Tech Support Webpage.
- The PI Square group for the Life Sciences professionals. This industry specific group may be able to field specific questions you have better than the general PI Square forum.
Thank you Rob!
I will have a look at that white paper, perfect.
Yes I stumbled upon that group you are linking to just before my post and I've already requested to join, we'll see if they let me in
3 of 3 people found this helpful
unfortunately there is not "the one Document" like a best practice guide to validate your PI System.
There is an very old document "Auditing the PI Server" (you should find with search function in tech support) which gives an starting point for audit trail settings.
Except of this you should validate your system regarding the policies of your company (computer system validation).
i suggest to keep special focus on account handling/Identity Access Management (if possible use windows integrated security and search the documents regarding "Security" - e.g. Configuring Security PI Server), Backup and Recovery Procedures, Data Ownership and Stewardship / segregation of duties.
a pain point already adressed by the Life Sciences User Group (see link from Rob) is the topic audit trail. at the moment there missing functionalities and also some information in PI Square as follows:
some of the postings adress electronic signature which is unfortunately not supported by the visualization tools (but if you're lucky you don't have the requirement in your URS).
these are just a few points you have to focus on. hopefuly you have good procedures regarding computer system validation wich lead you to the questions you might find answered in techsupport.
No, of course, I understand that there isn't one correct way to do it and no "wizard" to follow and every requirement will be fulfilled
Just after things that you mention, that's great. Things like the e-sign issue you brought up etc.
I have already found issues about printed/display names that is listed in the URS we received. In PI Vision for example you can only see the signed in users user-id and not the whole name... also found a note about it in the feedback forum.
Thanks for the links and comments, super.