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

Configuring an Oracle Database for 21 CFR Part 11

For auditing to work properly, you must grant database privileges to the owners of the audit tables and audited tables such as PRODDTA, CRPDTA. To do so:

  1. Start SQL PLUCS and connect to the instance as SYS.

  2. For each owner, such as XXSY, XXNJ, PRODDTA, CRPDTA..., enter the following commands:

    • GRANT CREATE PROCEDURE TO owner

    • GRANT CREATE TRIGGER TO owner

    • GRANT SELECT ON V_$SESSION TO owner

    • GRANT CREATE TABLE TO owner

  3. Restart the application and HTML services.