A High Level Risk Assessment is a tool that allows a relatively fast risk assessment for equipment or a process. This HLRA template is perfect for the initial risk assessment of a computer system or validation of automated equipment. It asks a sequence of questions that help determine the potential risk and impact on product quality and GxP. It also facilitates the formal documentation of the GAMP category and any additional actions that need to be addressed.

Some pertinent questions with regard to assessing GxP risks include: 

Is the system part of the environmental controls of GMP areas within the facility?

Is the system used during the manufacture of products?