1. Auditing Administration Including 21 CFR Part 11 Administration Guide
  2. Configuring an Oracle Database for Auditing

Configuring an Oracle Database for Auditing

You must grant the owners of the audit tables (F9500003, F9500004, and F9500006) and audited tables (for example PRODDTA, DD812) the privileges listed in this task.

  1. Start SQL*PLUS and connect to the instance as SYS.

  2. For each owner, enter the following three commands:

    • GRANT CREATE PROCEDURE TO owner

    • GRANT CREATE TRIGGER TO owner

    • GRANT SELECT ON SYS.V_$SESSION TO owner

      Note: The third command must be directly granted to the owner. Granting it to a role to which the owner belongs does not work.