Validating one process in a computer system
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Hi, has anyone focussed on validating a process within a computer system (low risk) whilst doing minimal testing (if any) in other areas of that computer system that support non-GxP processes. How did you describe the approach in the Val Plan? Thanks, Rick
What you describe is nowadays documented under "use of a risk-based approach" in the validation plan. In this section you need to justify the reason for limiting the testing of the system to only GxP or business critical funtions.