CSV - Periodic Review

devin

Registered
#1
As part of periodic review, assimilating the changes done in the system since initial validation.
1. System server and DB has been changed, does this require re-execution of IQ or only Design specification update?
2. If none of the system changes are functional, with no risk on daily operations/usage, it does not have any impact on the validated state of the system. Is this a correct statement?
3. The work Instruction/manual for system users is not a formal approved document. Is this a deviation to be recorded in periodic review?
 
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yodon

Staff member
Super Moderator
#2
For now, let's consider this one:

2. If none of the system changes are functional, with no risk on daily operations/usage, it does not have any impact on the validated state of the system.
What evidence do you have to make those assertions?
 
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