Evaluating the Effectiveness of Risk-Based Quality Assurance Models in Regulated Software Development Lifecycles
Keywords:
Risk-Based Quality Assurance, Software Testing, Regulated Software, QA Models, Compliance Testing, Risk AssessmentAbstract
In the context of regulated software systems—such as those used in healthcare, finance, and aerospace—the need for reliable Quality Assurance (QA) processes is paramount. Risk-Based Quality Assurance (RBQA) has emerged as a pragmatic approach to streamline QA activities by aligning testing efforts with the assessed level of risk associated with various components. This paper investigates the effectiveness of RBQA models within regulated software development lifecycles as of 2023, emphasizing compliance, defect detection, and cost-effectiveness. A synthesis of prior literature and an empirical analysis of RBQA adoption patterns across industries are provided. This research demonstrates that, while RBQA increases testing efficiency and regulatory alignment, its success hinges on accurate risk classification and the maturity of organizational QA practices
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