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Qdossier Qsauri
"C"

change control
Guideline or reference source
ECA GAMP5 Approach and Risk Management
Definition
A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.
Related Term
change management
 

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