1.1 This guide covers a process for computerization projects that require design and implementation of new hardware or software. It describes a process for developing computerized systems to meet requirements of both system users and regulatory authorities. This guide covers procedures, considerations, and required documents. 1.2 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.