October 10, 2002 at 5:50 am
I currently administer a system that was designed to comply with FDA requirements 21 CFR part 11. The company that designed the system implemented audit trace files for the database. They claim these are to monitor all activities on the database and keep a log of each one. These files reach a size of approximately 200 meg and then they begin a new file. Sometimes we only create one file in a days time but other times I have seen as many as twleve to fifteen created in a single day. When this happens I have to go and copy them to a cdrom to free up the space on the server. I have opened these files and viewed them in profiler and they have transactions such as a procedure to convert utc time to local time or things where the system logged information from the field controllers. I really don't know why the FDA would care about anything but a user accessing or changing information. I don't know that much about these files and I would like to learn more if anyone has any suggestions I would appreciate it.
October 19, 2002 at 12:00 am
No one has responded to this topic yet. Even if you don't have a complete answer, the original poster will appreciate any thoughts you have!
October 21, 2002 at 5:37 am
I know nothing about FDA 21 CFR part 11.
It sounds like they are profiler traces (just from the fact you can see them with Profiler).
I'm not exactly sure what you want to know. If they are from profiler, you must have some kind of job set up that's running Profiler on a recurring basis, and from that job you could find out how it is set up. Profiler has filters available, so if you are asking if you can eliminate certain stuff from it, the answer is a definite "maybe" depending on whether the filters meet your particular need. Whether you should or not, of course, depends on what you are mandated to retain.
If you want help adjusting the profiler, post some of what is set up and I bet a lot of people can help.
If you want help interpreting the legal requirements... well, good luck.
October 21, 2002 at 5:40 am
I assume it is using profiler, if so the level of tracing you must have, will be seriously reducing performance. You would be much better off using lumients log explorer. Just keep your transaction logs and you will have the changes that have been made.
Simon Sabin
Co-author of SQL Server 2000 XML Distilled
http://www.amazon.co.uk/exec/obidos/ASIN/1904347088
Simon Sabin
SQL Server MVP
http://sqlblogcasts.com/blogs/simons
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