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DI Risk Management Model

DI Risk Management Model

Identify a GxP Process needing DI assessmentMap Data Vulnerabilityto 9-BoxDetermine Data CriticalityDetermine current level of Data ControlsIn Red / Orange Zone?Define risk control strategy to avaoid Red / Orange zonesLevel of Control in place ensures inadvertent data integrity issues are unlikely to occur - but may not prevent intential falsification.Data MgmtHuman FactorsGxP ProcessYesNoDI Gap/Risk AssesmentData Process MappingGEMBA Walk
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publish time: 2021-04-04
Baiano Simelane

Here is a risk management model, from which you can see it should identify a GxP process needing DI assessment at first. Then, determine data criticality, map data vulnerability 9-Box, and determine the current level of data controls. Level of control in place ensures inadvertent data integrity issues are unlikely to occur - but may not prevent intentional falsification. Learn more details from this model, and try to make yours with ease.

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