throughout the system lifecycle. As each stage of the model will be flexible to support the the life cycle can be performed using various implementation and integration of preferred methodologies and project management processes, methodologies into the framework. Figure 2: Software lifecycle V 6. Design The framework will provide a software Unresolved Anomalies development roadmap, which complies with the Release Version Number regulatory guidance criteria, while introducing best practice techniques and methodologies that can be selected as required. For example a risk To ensure compliance whilst also achieving management process can adopt a Failure Mode software process improvement the following six and Effects Analysis (FMEA) method of identifying, software process have been identified as areas to mitigating and tracking risk and hazard issues. Also be focused upon as a mapping can be made from the continuous management of verification and these process areas to the twelve areas listed validation testing can be controlled and planned above. under a structured Test Process Improvement (TPI) model. Requirements Management The framework will provide a means of assessing Risk Management software engineering capability in twelve areas that have been defined by the FDA [7] as: Project Management Configuration Management Level of Concern Verification, Validation and Testing Software Description Software Design and Development Device Hazard and Risk Analysis Software Requirements Specification The model will help companies to measure their organisational capability and to track progression Architecture Design and achievements in each of the six process areas and against process capability levels defined in Design Specifications ISO/IEC 15504-2 [16]. Requirements Traceability Analysis Development Validation, Verification and Testing [8] 7. Assessment framework Revision Level History
throughout the system lifecycle. As each stage of the life cycle can be performed using various methodologies and project management processes, the model will be flexible to support the implementation and integration of preferred methodologies into the framework. Figure 2: Software lifecycle V 6. Design The framework will provide a software development roadmap, which complies with the regulatory guidance criteria, while introducing best practice techniques and methodologies that can be selected as required. For example a risk management process can adopt a Failure Mode and Effects Analysis (FMEA) method of identifying, mitigating and tracking risk and hazard issues. Also the continuous management of verification and validation testing can be controlled and planned under a structured Test Process Improvement (TPI) model. The framework will provide a means of assessing software engineering capability in twelve areas that have been defined by the FDA [7] as: Level of Concern Software Description Device Hazard and Risk Analysis Software Requirements Specification Architecture Design Design Specifications Requirements Traceability Analysis Development Validation, Verification and Testing [8] Revision Level History Unresolved Anomalies Release Version Number To ensure compliance whilst also achieving software process improvement the following six software process have been identified as areas to be focused upon as a mapping can be made from these process areas to the twelve areas listed above. Requirements Management Risk Management Project Management Configuration Management Verification, Validation and Testing Software Design and Development The model will help companies to measure their organisational capability and to track progression and achievements in each of the six process areas and against process capability levels defined in ISO/IEC 15504-2 [16]. 7. Assessment framework
A_Software_Process_Development_No.55.docx