An Analysis of Software Requirements Specification Characteristics In Regulated Environments

Abstract

Requirements Engineering is the set of activities involved in creation, managing, documenting, and maintaining a requirements’ set for a product. Engineering involves the use of systematic repeatability techniques to ensure that the Software Requirements are complete, consistent, valid, and verifiable. Software Requirements Specification is an organized process oriented toward defining, documenting and maintaining requirements throughout the development life cycle. Many authors suggest that requirements should always focus their claims on what the software product needs to address, without specifying how to implement them. However, the detail of Software Requirements is influenced by several factors such as: organizational thinking; existing specification standards; and regulatory needs. This work fits exactly with regulatory needs, where the characteristics of Software Requirements Specification in Regulated Environments such as aeronautics, railways and medical are presented and explored. This paper presents and analysis of software requirements specification characteristics in regulated environments. The four characteristics identified are: consistency (internal and external), unambiguity, verifiability, and traceability. The paper also describes the three standards used in these regulated environments (RTCA DO-178C, IEC 62279 and IEC 62304) and examines their similarities and differences from a Requirements Specification standpoint. The similarities and differences will be used to address a future requirements framework universal process that can be configured to address each standard by the usage of Software Process Lines.