21cfrpart11 seems to require a lot of documentation. Most of that we already have, but on some we still have to work.
In particular, there’s some documentation and procedures on wich we don’t have a clear idea about the restrictions and the mandatory aspects as it seems such broad areas.
In particular, about disaster recovery, contingency plans, backup, what are the main aspects that should be pointed out in documentation and procedures? What are the areas that should be taken care of by the SW developer (us), the HW installer/maintaine r, the customer? Is there around some examples of them from which we can start developing our owns?
thanks in advance