GxP Criticality Assessment Process

How the computer system s validation requirement was identified should be explained, including how any prioritization was determined and how any changes in priority are managed. Identify procedures used in criticality assessment. 

The overall computer validation strategy within the Validation Master Plan should be outlined, as well as the life cycle model to be applied and the validation procedures to be used. 

The approach to change management should be mentioned, referring to relevant change control procedures. 

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Introduction and Scope Organizational Structure GxP Criticality Assessment Process Validation Strategy Change Control Procedures and Training Document Management Timeline and Resources... 

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