Auditing to Uncover Risks in the World of Computer Systems Validation
Society Of Quality Assurance
This session will address the primary elements of risk that one finds in the world of Computer Systems Validation – the risk that a system that should be validated is not validated; the risk that a validated system does not remain in a validated state; and, the risk that quality assurance processes are not effective – in terms of what an auditor should look for and how the auditor should perform the audit.
At the end of the session, the attendees will be able to
- Identify the primary risk areas associated with computer system validation;
- Understand the nature and impact of these risks;
- Understand how to audit to uncover such risks.