Creating Required Oracle Table Spaces and Users

When implementing 21 CFR Part 11 across multiple path codes on an Oracle database, you need to create table spaces to house system/configuration tables used for 21 CFR Part 11. For each path code that you plan to configure, you should create at least four table spaces:

• Two table spaces for storing Julian configuration tables.

• Two tables spaces for storing non-Julian configuration tables.

To create the table spaces:

1. Verify the disk space and location for the Julian and no-Julian table spaces for each path code to be audited.

2. Connect your database via SQWLL Plus.

3. Log into the database with SYSDBA User and perform the database operations to create table spaces, database users and owners, and grant rights to owners.

4. Issue the create tablespace command:

   • Create tablespace XXSYT datafile 'YYYY' size 35M autoextend on

   • Create tablespace XXSYI datafile 'YYYY' size 35M autoextend on

   • Create tablespace XXNJT datafile 'YYYY' size 35M autoextend on

   • Create tablespace XXNJI datafile 'YYYY' size 35M autoextend on

     Where:

     • XX is a denotation of the path code for which you are setting up CFR Part 11, for example DV for Development, PY for Prototype, or PD for Production.

     • SY indicates the system or configuration tables with Julian dates.

     • NJ indicates system or configuration tables tat are non-Julian.

     • T indicates that this is the table space for storing table level information.

     • I indicates that this is the table space for storing index level information.

     • YYYY is the location and name of the database data file, for example: /u01/oracle/data/dvsyt01.dbf

5. Repeat this process for each path code you would like to configure for auditing.

6. Create the required Oracle database users and owners.

7. While still logged into the database as a "System" user, issue the following commands:

   • Create user XXSY identified by password default tablespace XXSYT temporary tablespace TEMP quota unlimited on XXSYT quota unlimited on XXSYI

   • Create user XXNJ identified by password default tablespace XXNJT temporary tablespace TEMP quota unlimited on XXNJT quota unlimited on XXNJI

     Where:

     • XX is a denotation of the path code for which you are setting up for auditing, for example DV for Development, PY for Prototype, or PD for Production.

     • SY indicates the system or configuration tables with Julian dates.

     • NJ indicates system or configuration tables tat are non-Julian.

     • T indicates that this is the table space for storing table level information.

     • I indicates that this is the table space for storing index level information.

8. Repeat this process for each path code you would like to configure for auditing.

   You have now successfully created the required database table spaces and users to configure auditing for your identified path codes.