I’m a consultant validation, and actually I’m validating a SAP accorfing to the GMP and 21 CFR PART 11 rules.
THe problem is that th customer has required a document with the main GMP problems in SAP application to minimize the risk in the Operationa Qualification.
I looked for in internet but I only found a document which has modulewise US FDA cGMP affected areas as well as 21 CFR Part 11 affected modules.
Are anybody who now which are the main gaps (according to the GMP rules) in SAP?
Thanks a lot.