Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing (RiskVal)

• This procedure defines a method for determining the system risk level and the risk levels associated with failures of a computer system to meet requirements.
• This procedure adapts the risk management standard (ISO 14971) to computer systems. A methodology for a high-level risk analysis is used to determine the risk level of a computer system.
• This procedure also includes a method for managing the risks associated with computer system failure by adapting and extending the 13 step risk management process described in ISO 134845.
• The risk evaluation and mitigation steps are included, as well the assessment and mitigation of residual risk.

It Provides information on:

• Responsibilities
• Method
• Quality records