Purpose for command Audit Role 2 drop down in iCommand

[Former Member]

hi

What is the use of command Audit Role 2 ?

For Example

i configured iCommand Applet with Command Audit Role 1 and command Audit Role 2 for some data base operation.

SAP xMII security manager asking Audit Role 1 credentials and then Audit Role 2 Credentials when executing the data base operation.In real time Audit Role 1 will play first user(operator) and Audit Role 2 will play second user(superwiser).SAP xMII asking Audit Role 1 and Audit Role 2 credentials in continously for first user itself.

why it's asking command Audit Role 2 also to first user itself.how to first user know about second user credentials?

[Former Member]

Hi

Thanks for your valuable inputs.

I know about 21 CFR Part-11.

As yet i am not clear about one thing is how xMII support for 21 CFR Part-11 functionality.

I studied xMII help document also but not able to understand.

Can you provide sample for how xMII supports 21 CFR Part-11?

[salvatore_castro]

Satheesh,

Take a look at the Federal Regulations for pharmaceutical companies under the following:

21 CFR-Part 11

This requires a two stage audit trail to be associated with any changes made or acceptance of a batch. Basically when an operator performs some command update to the system of record their supervisor/quality specialist/etc.. also has to approve of the change. This is the primary reason for the second level of authentication, I'm sure that there are more in other industries though.

Sam

[Former Member]

Hi

Thanks for your valuable inputs.

I know about 21 CFR Part-11.

As yet i am not clear about one thing is how xMII support for 21 CFR Part-11 functionality.

I studied xMII help document also but not able to understand.

Can you provide sample for how xMII supports 21 CFR Part-11?

[Former Member]

Hi Satheesh,

on which xMII version you are. I'm not sure if you have read this, so I post this link from the 11.5 help.

[http://help.sap.com/saphelp_xmii115/helpdata/en/Electronic_Signature/Electronic_Signature_Overview.htm]

Maybe it helps.

Ciao

Martin

[Former Member]

Hi Satheesh,

Maybe google helps:

- 21 CFR 11 Supervisor

- FDA 21 CFR Part 11 Final Rule

Ciao

Martin