GXP

Implementing Adequate Data Integrity Risk Assessment Tools

One of the most important tools is the DI risk assessment. The DI risk assessment is intended to identify the risk of each system, enabling a risk-based approach to the prioritization of remediation activities. Because the DI tool will be used for prioritizing remediation activities, it is imperative that these tools are objective, developed in alignment with regulatory guidance, and simple to execute. Using DI risk assessment tools that are not objective and based on philosophical opinions and interpretation of regulatory requirements create the issue of misclassification of DI risk. Using DI...

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