FDA (21 CFR 11) in control system WinCC etc

Any one worked on FDA approvals on control and SCADA systems, esp on Siemens WinCC & S7 PLC.

Runtime and Documentation control via this software.

Need to know more on any implementation. Please post your exp.
Will share our exp.

Ok !
Any one worked on "WinCC Logn" Version 1.1, and are you able to retain the users in WinCC application? Is it a bug in this version ?

Well "WinCC Audit" looks to be good and do not know if others have doc control package inside SCADA as WinCC does.

Would like to share more , but need a friend here !!