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Software Management Domain
Published in Marvin Gechman, Project Management of Large Software-Intensive Systems, 2019
Software Verification and Validation (V&V) are two related but separate procedures. Because they are so related, there can be confusion as to how they differ. Verification: Ensures that each developed software function works correctly. Verification techniques include Managerial Reviews (see 5.3), Peer Reviews (see 6.5) and code walk-throughs (see 11.4.4).Validation: Ensures that the final product incorporates all of the system requirements. System testing also validates the inclusion of all system requirements. Validation techniques include White Box and Black Box testing: White Box Testing: An internal perspective of the code functionality often assisted by automated testing tools.Black Box Testing: An external perspective with little concern or knowledge of the internal structure of the software. Inputs are provided, and the outputs are compared to the expected outputs.
ISO Standards
Published in Boris Mutafelija, Harvey Stromberg, ® v1.2 and ISO Standards, 2008
Boris Mutafelija, Harvey Stromberg
Plans for software quality assurance include identification of quality assurance procedures, responsibilities, and schedules. Software quality assurance activities are expected to be coordinated with other supporting processes such as Software Verification, Software Validation, Software Review, Software Audit, and Software Problem Resolution. Product assurance requirements include ensuring that plans required under the contract are developed and that products satisfy their requirements. Process assurance requirements address the need for those who are implementing software processes to follow plans, measure processes and products, and properly train the project staff.
Software Design
Published in Richard C. Fries, Handbook of Medical Device Design, 2019
Technical software development activities produce work products that must be verified. Static analysis techniques such as reviews, walkthroughs and inspections, and dynamic techniques such as unit testing and system testing are used to verify the work products. These techniques will be discussed in the chapter on software verification and validation.
Nuclear Reactor Transient Diagnostics Using Classification and AutoML
Published in Nuclear Technology, 2022
Pedro Mena, R. A. Borrelli, Leslie Kerby
In the United States, the U.S. Nuclear Regulatory Commission requires compliance of IEEE std. 1012-1998a“IEEE Standard for Software Verification and Validation,” IEEE (1998). and NUREG-0800b“Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants,” U.S. Nuclear Regulatory Commission. for software and simulation quality assurance.25 Because of this, it is likely that any system that will be given control of reactor components will be subject to arduous regulatory review, if considered at all. The models developed in this experiment are not intended to be used in any system with direct control over a reactor and as such should be subject to a more straightforward approval process.
Hybrid System Level and Coarse Grid CFD Tool for Three-Dimensional Natural Circulation, Mixing, and Stratification Modeling
Published in Nuclear Technology, 2022
R. C. Harvill, J. W. Lane, T. L. George
The entirety of the GOTHIC software (GUI, transient solver, and postprocessor) is developed and maintained under a software QA program that complies with 10CFR50 Appendix B, 10 CFR 21, and applicable portions of the American Society of Mechanical Engineers (ASME) Nuclear Quality Assurance-1 (Subpart 2.7). As a counterexample, INL considers their version of RELAP5-3D that is available to the user community to be research and development software. As such, it is provided as non-safety-grade software. This imposes extensive software verification and validation (V&V) efforts on the end user to perform a commercial grade dedication and apply the software for safety-related applications. Similarly, the SNAP GUI (Ref. 44) is also considered non-QA, so the analyst can use it as a convenience for developing input models, but the ASCII-based card input deck is still the official input that must be QA reviewed. SNAP takes no responsibility for the accuracy of the translation from the GUI to the input deck. Meanwhile, GOTHIC’s QA pedigree allows it to be used as a safety-related analysis tool, including the GUI.
Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy
Published in Expert Review of Medical Devices, 2020
Somryst was subjected to software verification and validation testing which demonstrated that the device met its design, implementation, and cybersecurity requirements and functions as intended [59]. As described above, the therapeutic content of Somryst was validated in two randomized controlled trials of its web-based precursor SHUTi, demonstrating robust evidence of clinical efficacy and safety. The results of software testing and clinical trials validated Somryst for its intended use for the treatment of adults (ages 22 and older) with chronic insomnia by improving a patient’s insomnia symptoms. Somryst also met all Special Controls required by federal regulation for Class II, computerized behavioral therapy devices [60]. Thus, Somryst was deemed substantially equivalent to the predicate PDT device ReSET and received FDA clearance.