21 CFR Part 11

2nicholas

2nicholas

Active Member
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.
 
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