Internal Audit

Internal audits are a quality assurance activity and are conducted by someone who is independent of the activity being assessed.  This is different to monitoring which is conducted by someone who is not independent of the activities being audited. 

Examples of an audit that may be performed at any organisation, including the three Melbourne Children’s partners, are:

System audits – looking at the functionality of a complete system, e.g. Florence eBinders, data governance/management, complaints management

Process audits – looking at the performance of specific processes within systems, e.g. records of training, currency of certifications, assessment/reporting of safety events

Vendor audits – assessment of external service providers

Trial-specific audits – assessment of trial-related activities in accordance with the protocol, SOPs, GCP and applicable regulatory requirements

Documentation audits – review of trial-specific or system documentation, e.g. protocols, interim reports, computer system validation package

Find out more at MCTC Quality Management Systems.