GXP

Investigation of Deviations: Why Are They So Painful?

CHALLENGES WITH THE TRADITIONAL DEVIATION INVESTIGATION PROCESS The traditional deviation investigation process is typically negatively impacted by several factors that make this process ineffective, subjective, costly, and insufficient. These include people factors, metrics-driven processes, and inadequate process execution.  People factors are involved in all of the above. People Factors The biggest factors that may negatively impact on the effectiveness of the deviation investigation process are people factors. Problems that may adversely influence the deviation investigation process include...

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