Hierarchy of Validation Plans

The term Validation Master Plan usually denotes that the associated project covers large or multiple eomputer systems. For example, where more than one Vahdation Plan exists to cover the implementation of a system, a supervisory plan should be produced to define the overall approach. Similarly, if the computer system is relatively small and contained in its entirety within a standalone pieee of equipment, then the Validation Plan may be embodied within the overall Validation Master Plan for the equipment/area in question. 

GAMP 4 suggests a hierarchy that might look like this  

Whatever pattern a supervisory validation planning takes, it must clearly identify the scope of any subordinate Validation Plans. 

Validation Master Plans typically have three main sections. The first section states how the phar-maceutieal or healtheare eompany s own validation philosophy and policy address regulatory GxP requirements. The seeond section defines the scope of validation, identifying which computer system systems require validation. All computer systems whose malfunction could possibly affect 

Coding, Configuration Build Coding, Configuration Build  

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