scope:

1.1 This guide covers a procedure for selecting and acquiring an existing commercially available system, through a single vendor, that includes all necessary hardware and software to perform a specified job. This guide describes a systematic procedure for selecting a computerized system, and for specifying the requirements that the system must fulfill. Installation and use of the system are discussed. Several important items of system documentation are described.

1.2 This guide addresses only those project phases necessary for the selection and acquisition of off-the-shelf computer systems. If a customized system is required, or if any portion of the system needs to be designed, refer to Guide E 622 for a more detailed procedure. For a clinical laboratory system, refer to Guides E 792 and E 1029. For computerization of existing equipment, refer to Guide E 1206.

1.3 In following this guide, users should comply with all local requirements such as labor contracts, organization policies, applicable laws and regulations, etc.

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.