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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. These analyses are the basis for risk based adjustments to the validation of computer systems. 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. The system risk level is used to determine the validation activities and the rigor and intensity of those activities. A detailed risk evaluation is also presented for determining the risks associated with the failure of the computer system to meet specific requirements. The results of the detailed analysis are used to mitigate risks, and to determine the level of testing that ought to be done on the ability of the system to meet each requirement. This analysis can result in a large reduction in the testing that needs to be done for a validation.

Provider: BPA
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Product Details

  • 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

 

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