When understood as a process, validation is a transverse activity to every life cycle stage of the system.In particular, during the development cycle of the system, the validation process is performed in parallel with the system definition and system realization processes and applies to any activity and product resulting from this activity.After operational needs are assessed and the concept of operations (CONOPS) and high-level concept definition are completed, the next step—and typically the first task on development projects—is to discover, elicit, collect, define, and analyze requirements.Requirements cover various aspects of a capability or system—user needs, behavioral, quality, implementation, etc.However, specific guidelines for the validation of these methods are lacking.Here, a pragmatic approach to conduct in-house and inter-laboratory validation studies for GMO screening methods, is proposed.
Additional parameters and performance characteristics are often evaluated for methods of greater complexity.
This is achieved by performing a series of experiments on the procedure, materials, and equipment that comprise the method being validated.
The experimental results undergo statistical analysis, and a series of pre-defined acceptance criteria are applied to the results.
Definition: Requirements define the capabilities that a system must have (functional) or properties of that system (non-functional) that meet the users' needs to perform a specific set of tasks (within a defined scope).
Keywords: agile, elicitation, elicitation techniques, project scope, requirements, requirements attributes, requirements elicitation, root cause, scope, spiral, stakeholders, user requirements, users, waterfall MITRE SE Roles and Expectations: MITRE systems engineers (SEs) are expected to be able to elicit business, mission, and operational needs from operational users and other stakeholders.
Such guidelines could be adapted to other areas where qualitative q PCR methods are used for molecular testing allowing to implement easily a more reliable screening phase where necessary.