When Evaluating change, you may want to ask the following:
What is the system levelof the aspect being changed?
· Top Level (or Critical)
· Mid Level (or Moderate)
· Low Level (or Minor)
But how do we definethe level of the aspect being changed?
The consideration of the aspect level determines therisk associated with the change and in turn, drives the work requiredto affect the change. Therefore, werecommend that this should be determined by asking the following LevelDetermination questions while assuming you have a validated status:
Define system levels and change requirements inthe original validation. Here we alsotie back again to the value of a robust and comprehensive Validation Plan (VP).The scope of the overall system and the boundaries of its individual elementsshould be well-defined within the VP and complimented by the individualvalidation documentation based on overall risk (Riskapproach.) You may not be able to capture all cases but all reasonableones to expect should be listed with requirements for verification testing orrevalidation following changes to the system or its components.
1. This allows for risk review of the system at thetime of its validation and provides guidance for system users in the future.
2. It also provides for original validation reviewwhenever system changes are proposed and for validation plan review to evaluateif system changes are within the predefined system scope and componentboundaries.
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