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Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing (RiskVal)
Provider: BPA
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Shipping: Available for download - Link will be provided in My ComplianceOnline section
Price:
$150.00
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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