Software Development Plan

Review of all software development plans and software requirement speeifieation based on NUREG/CR-6101 eheeklist for safety systems developed by GE NUMAC and Eaton. 

In addition, as the consultant to the GE IVVT, Computer Dependability Associates (CDA), provides advice on GE IWT strategy, IV V plan and other software development Plans. Also, they evaluate the performance of GE IWT in each software phase, and provide support in interpretation of the Codes and Standards as neeessary. 

Completed Software Development Plan for JIMO project... 

Each cycle consists of plan, execute, and evaluate phases. Set goals, level of investment, and acceptable risks plan and decide what will be evaluated and how it will affect future cycles determine fallbacks execute the plan evaluate the outcome. For software development cycles this often translates into plan, specify, design and implement, and evaluate. 

The protocols and software developed in this study will give the Pacific Disaster Center tools that will enable it-and other agencies such as the Hawaii State Department of Land and Natural Resources and the U.S. National Weather Service-to conduct dam breach hazard assessments more easily. Results of these assessments are expected to be of value for disaster planning, emergency response, and flood warning. 

Any serious software developer will follow a formal software development methodology that includes the documentation necessary to support the software at each development step. A quality audit of the software developer will determine the adequacy of testing performed and whether the tests plan, procedures, and results are properly documented. The quality audit must include an inspection of the unit testing process. 

The validation was performed according to the Roche Computerized System Validation Policy and Guidelines. This comprised the definition of a Validation Plan, the performance of the planned activities, and the creation of a Validation Report. In addition, the project was accompanied by external consultants providing knowhow regarding the validation-specific aspects of the development, including the management and auditing of the software developer. The scope of the validation activities was defined by GMP Analysis (also known as a GMP Assessment). The system... 

November 1997 Warning Letter The software test plan currently in use included no description of how test cases were developed or how thorough test coverage is to be achieved. ... 

A configuration management plan shonld be established to outline the process to be followed to ensure that configuration and version control is established for the software, development tools, and supporting docnmentation that are nsed. This will enable accurate configuration baselines to be taken at specified points in the software development life cycle. 

If the method does not meet run time criteria or robustness requirements, it may require further optimization. Method development optimization is typically continued until the objectives outlined in the development plan are met. Method development experts often have the experience necessary to adequately optimize the methodology others may benefit from the documented and organized development approach of available software packages. Several commercial packages are available that combine classical chromatographic theory with statistical design to predict optimum separation conditions with a minimum number of experiments. 

Pre-shipment inspection can be performed along with vendor audits to address issues such as software development and quality assurance plans, operational reports, and specific vendor/purchaser inspection reports. 

The CSD is distributed as a complete system, incorporating the database itself together with software for search, retrieval, analysis and display of information. At the time of writing (September 1991) two systems are available. Version 3 and Version 4, whilst a further enhancement to a Version 5 system is planned for distribution during 1992 (Release October 1992). Complete details of these software developments have been published [4] so that only brief and necessary background material is given here. 

Without exception, the large suites of quantum chemistry programs have been written by research workers and enthusiasts in quantum chemistry and not by software developers. They have not been through the design, planning and specification routes which are now routine in software development. The interests of these researchers (who were and are their own systems analysts, specification... 

Calibration certificates must be available for the test instruments used. Also, Contingency Plans must be confirmed as operable. The degree of testing may be alleviated by the amount of predelivery testing conducted by the supplier in association with the confidence in the supplier s software development practices determined by the Supplier Audit. Predelivery tests should be witnessed or at least the results reviewed and a summary report produced. 

An iterative, user-centred approach has advantages in many areas of product development but perhaps none more so than in user interface design. Manufacturers should actively plan to work and re-work a user interface many times in the course of a project. Of course the earlier this process begins, the more opportunities there are to tweak the design without compromising project timescales. In the context of a time-bound software development project it may not be realistic to evaluate every screen and function in a system so it makes sense to prioritise those which are used frequently and/or are critical for safety. Even after go-live it is invaluable to solicit feedback from users once they have had the time to use the system in anger and address areas of concern. 

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