Risk Assessment and Management Specific to Computer Validation
Drug Information Association 42nd Annual Meeting
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 insufficient objective evidence is generated; and, the risk that significant user requirements will not be met due to testing exceptions. Along with defining and describing these risk areas, the session will discuss the business and regulatory impacts of these risks. One must be able to recognize risks that exist in this arena, and appreciate their significance, so that one can be a position to manage them.
At the end of the session, the attendees will be able to
- Identify the primary risk areas associated with computer system validation;
- Understand the impact of these risks;
- Understand the differences in methods to assess and manage risk.