FDA Compliance and SQL 2000

We have an application using SQL 2000 database that must be FDA compliant. Anyone with FDA compliance experience? Know any products that will audit database changes? How about validation of backups and restores.

Thanks!

I beleive that Quest Software has products to audit schema changes to the database.

SQL Server can validate backups nativly. Quest may have a third party production which can do this as well.

|||For auditing, Idera has a really good product called compliance manager that will enable you to track pretty much whatever you need to track. If you are only tracking data changes, you can always write you own custom data auditing solution without too much grief. Hope this helps.
Tim|||

Thanks for all your help. This gets me going in the right direction.

GDM