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21 CFR Part 11 Compliant Database Monitoring

The ComplianceBuilder™ Database Monitoring (CB-Database Monitoring) module offers management and control of any RDBMS-based system, including SQL-based applications, batch systems and custom-developed DB applications. CB-Database Monitoring ensures that any changes or modifications to a monitored database are properly tracked in adherence to 21 CFR Part 11.

CB-Database Monitoring is designed to monitor data changes in Oracle database tables, record each change event and maintain an archive of all changed records. You can configure the system to issue and route data change notifications and to require an authenticated acknowledgement and sign-off. CB-Database Monitoring can monitor data changes on one or multiple Oracle databases using various parameters via a Web menu-driven user interface.

Audit Tables and Data Change Notifications

For each database table that is monitored, CB-Database Monitoring creates a corresponding Audit Table that mirrors the structure of the monitored table. In addition, the platform creates triggers that monitor the target table and transfer any data changes to the Audit Table. The transferred information includes a record of the change event as well as the complete record that was modified.

Data change notifications can specify whether the system should issue and route notifications upon detecting database table changes. If notifications are issued, CB-Database Monitoring sends a notification to the address where the change originated or to a specific pre-configured group. You can specify whether notification sign-off is required and how long the system should wait before it “times out” an unacknowledged notification.

If you change the structure of a table that is monitored, you only need to recreate the corresponding Audit table using the “Recreate” function. The new Audit Table based on the new structure is created automatically, and the old Audit Table is preserved.

Reporting

Reporting offers comprehensive database change reporting capability as a standard feature. The SQL Data Changes Report displays data from monitored RDBMS records in both summary and detailed formats. You can optionally configure the report to display only selected database tables or fields or simply the old/new values of the data that was changed.

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