OBJECTIVE:

The initial objective of the presentation is to explain how to setup and use a system-wide Data Audit Trail.

Explain in detail what are the regulatory requirements for an Audit Trail.

Explain practical considerations about an Audit Trail.

Briefly mention IQ, OQ, PQ phases and associated project activities and deliverables, with specific attention to validation of the Audit Trail functionality.

METHODS:

Show example validation test scripts and test results of various data changing scenarios, in use at live pharmaceutical sites.

Review setup of the database, the programs and consider future database upgrades.

Review the specific requirements of a regulated Audit Trail with full historical before & after data breakdown.

Demonstrate site examples to re-enforce the usefulness of a complete Audit Trail for system monitoring and support, by Production, QA or other internal groups.

Explain how to generate an offsite copy of the Audit Trail for external review by external auditors.

RESULTS:

Attendees will be able to prepare for future projects with a better understanding of how an Audit Trail can be established. System upgrades or the introduction of new functionality should not be a stressful project, if managed sensibly.

Being able to manage a testing scenario, from design, to test script creation and generating test results.

Develop SOPs to record how the Audit Trail is installed, upgraded and tested.

Better understanding of the elements of an Audit Trail and how to implement and validate this functionality, to the regulatory level.




Powerpoint Presentation - approx 40-50 slides, quick paced, 30-50 minutes, as required by the conference convenor.