GXP

Change Control for Functionally Equivalent Like-For-Like Changes | IVT

Risk evaluation of change is a critical determination. At one extreme, changes may be significant, representing a high risk to processing or other operations. Such changes require full validation and qualification. At the other extreme, changes may be completely insignificant with minimal risk to patient, product, process, or equipment. Functionally equivalent (i.e., “like-for-like”) changes are often judged to be changes in this latter category. Like-for-like changes are minimal changes made to processes, equipment, utilities, facilities, computers, or other systems. Like-for-like changes...

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