21 CFR Part 11 Issues

[2nicholas]

Hi Guys,

I have been trying to setup this audit feature and facing few critical issues. I wonder anyone of you out there able to share and give some guidelines.

Issues:
1) The system seems unable to capture those important information such as User ID, Program ID and Workstation ID. Instead it returns as 3RDPARTY. I'm not sure this is something normal and acceptable by US auditory board.

2) Base on reply from Oracle GSC and manual, the system only return correct audit info thru OK and Delete event. I had tried, it seems not always true. For e.g. i tried P4101, DMAAI - P40950, AAI - P0012 etc unable to capture those correct audit info.

3) Is there anyway to configure such that the audit triggering is not just bounded by OK and Delete.

I'm hopeful those who had successfully implemented this feature able to share your experiences.

All input and advice are much appreciated.

Thank you.

 

[2nicholas]

I manage to figure out what went wrong. After you had activated, you need to logout and relogin in order for the system to take effect. Never know it was so simple.

However, i'm stuck in another problem. This feature seem unable to work on this file name more than 5 characters. For instance, F41021, F41002, F76B003, F76011 etc. I had log call to GSC and awaiting for their response.

Appreciates if anyone of you can share the inputs.

Rgds,

 

[TAV]

I am pretty certain 5 characters should not be an issue but just an FYI the files audited through this tool are renamed on the 400 so you need to be aware of that since there are limits due to the naming conventions. Just look up the files on the 400 by looking at what the file now points to. For instance the F41021 will actually be a logical pointing to the real file (something like F41021A) and the new logicals will be like F00000101, F0000102, F0000103 and so on so the files on the 400 have changed. Same through ODBC but different as actual object in native 400 mode. Just an FYI.

 

[2nicholas]

The limitation could be on AS400 platform as the max file name is up to 10 characters. For instance, once activated F0101, 3 CL programs which serve as triggering program (Insertion, Update and deletion) will be created F010100001, F010100002 and F010100003. Few new logical files will also be created and named it something like F010100001, F010100002 etc. As such those file such as F41021, localization files etc will not be able to activate. Have raised an enhancement request SAR to Oracle and let see how the outcome.

Anyway, thanks for sharing.