A Risk Assessment is important in a computer system validation because it can help define the depth of your validation effort by identifying the critical requirements that need to be mitigated. This will help to produce an approach that is commensurate with the level of risk the system poses. A functional risk assessment is performed following the creation of the functional requirements specification to identify potential risks. Mitigation activities are then planned to manage those identify those risks, focusing on the critical areas.
A risk assessment uses a simple scoring system documented in a matrix to produce the level of risk. This customizable template will help you determine risks and identify their priority.