Qualifying Infrastructure Elements

Environmental requirements for computer systems and media storage areas must be documented. In particular, computer rooms should be designed such that computers and data are secure and maintained within the manufacturer s recommended environmental limits for temperature and humidity. IQ must demonstrate adequate security, environmental controls and maintenance programs. 

All hardware platforms with their associated peripherals and operating system software must be defined in a technical specification. Detail regarding resilience against system failure, such as mirroring, should be included. 

Installation plans and IQ must be executed to demonstrate the correct installation. Operating procedures must be approved, and operators following these procedures must be trained. 

Both the physical and logical attributes of the network should be defined in technical specifications. Textual descriptions supported by diagrams, addressing OSI layers 1 and 2, should be produced, defining all networks at both local and wide area levels. Documentation should specify all physical components. References should be made to the industry-wide standards that were followed. 

Full descriptions should be provided of the logical methods of data transmission, addressed by layers 3, 4 and 5, throughout the network. The protocols described should clarify how devices exchange information, any routing used, in what form the information is transmitted and how multiple devices communicate simultaneously but successfully. 

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