However, this process is generally more straightforward for most application elements compared to infrastructure elements. The company typically has no direct influence on the design and manufacturing of components like servers, network switches, etc., which are essentially off-the-shelf purchases. After confirming the acceptability of the initial component build, new components are usually configured to a standard, and the testing of each build may be minimal (e.g., confirming network connectivity between nodes) or even non-existent (e.g., relying on a review-by-exception approach). Certain components may undergo initial verification but might also require additional configuration and subsequent verification of that configuration. Infrastructure, which continuously evolves to meet evolving business needs, should be systematically managed to maintain a controlled state. Both confirming the fitness of components for their intended purpose and managing them to remain controlled often involve automated processes. The dynamic nature of infrastructure, coupled with the widespread use of standardized components following the "one qualification, many implementations" model, represents the primary distinction emphasized in EU Annex 11. It's important to note that infrastructure software typically falls under GAMP® category 1, meaning it is qualified rather than validated. This distinction recognizes the unique characteristics of infrastructure components and their management within regulated environments.