CSV Auditor Training Post Test

Who is responsible for ensuring that all documentation and data are properly available during the audit?

• Business Owner

• Process Owner

• System Owner

• Quality Unit

What qualification and knowledge are recommended for the lead auditor of computerized systems?

• Understanding of FDA regulations

• Familiarity with risk assessment methods

• Knowledge of manufacturing processes

• Understanding of computerized system development and regulatory requirements

What aspects should be evaluated by the auditor for a computerized system?

• Data integrity and user competency

• Incident and deviation management only

• Change control and system performance only

• Backup and restore procedures only

What should an audit report include?

• System validation results

• Risk assessment and root cause analysis

• User competencies and audit trail

• System backup and restore procedures

Which system should be selected as a prioritized system for evaluation during the audit?

• Any computerized system within the organization

• Non-GxP computerized systems only

• GxP computerized systems

• Systems with the highest user competency

Who should review and approve the CAPA report?

• Lead Auditor

• System Owner

• Process Owner

• Quality Unit

The scope of the audit include the following activities: Prepare Audit Team - Prepare Audit Plan - Audit Report and Verification

• True

• False

Process Owner (Department Head): Responsible for ensuring accessibility, searchability, and availability of data and information stored in the system during the audit.

• True

• False

Risk assessment only perform after computerized system validation done and should be written in validation report.

• True

• False

Computerized system validation is divided into 4 categories according to GAMP 5, namely categories 1, 3, 4 and 5

• True

• False