Planning testing strategy

The Validation Plan should also clearly indicate the split of responsibilities between user and supplier. It should be noted that the supplier is normally involved in all levels of testing. The Validation Plan should state that an independent expert (often QA), who will confirm that the testing is being carried out in accordance with the documented test strategy, may witness testing. This is important where the software is developed externally, or where the development is taking place centrally on behalf of several sites. 

Overview of the nonclinical testing strategy or nonclinical drug development logic plan. 

M. Abdou, D. Sze, C, Wong, M, Sawan, A. Ying, and N. Morley, US Plans and Strategy for ITER Blanket Testing, The 16 ANS TOFE Meeting, Madison, 2004,... 

Test Strategy - Sets out the strategy and general approach to testing the systan, the methods employed, roles and responsibilities, status reporting, standards followed, defect management plan, etc. In some cases this detail may be incorporated into the Test Plan. 

Figure 8.4 shows our workflow for structure elucidation via MS, following the plan, generate, test strategy used in DENDRAL (Section 8.2). The focus is on determination of the molecular formula and structure. For interpretation we use MS classifiers, which provide information on both element composition and structure (see Appendix B). We use classifiers described by K. Varmuza and W. Werther [324, 333, 335] and develop new classifiers based on different classification methods (Subsection 8.5.2) and new structural properties (Subsection 8.5.3). 

The spectrum of what constitutes a validation of a POCT device is broad and may range from a superficial examination of the device to an extremely detailed and comprehensive assessment of both analytical and clinical performances. The extent of validation may also depend on the device itself for example, the next generation of an established POCT device may only need to demonstrate non-inferiority from the previous model. However, a POCT device for a new analyte may require a more in-depth assessment that assesses analytical performance and compares the device to existing testing strategies and clinical pathways. Validation plans for POCT devices should be completed before implementation with involvement of local laboratories as stipulated by local accreditation bodies. 

Overall review and test strategy in Quality and Safety Plan ... 

Overall test strategy in Quality and Safety Plan showing steps to integration and including test environment, tools, and provision for remedial action ... 

Test Management is mentioned neither in ISO 12207 nor in ISO/IEC 15504, but is of crucial importance for large and complex projects. The test plan that includes the test strategy, test schedule and the allocated resources should already be developed during the concept confirmation phase. For small projects the test plan can be part of the overall project management plan for large projects the test plan should be a dedicated document which must be synchronised with the overall project management plan. 

While you may wish to defer a firm decision about where, specifically, to start rolling out the system until the pilot test is completed, it s wise to consider a number of options as part of the planning process. The priorities you identified in Chapter 5 (both facilities and elements) provide useful guidance similarly, the implementation strategy you have adopted (companywide, facility-specific, or hybrid) will affect these decisions. 

Fig. 103 shows all scenario profits in the one-phase and the two-phase optimization case as well as the sales quantity index the two-phase optimization results do not disperse as strong as the one-phase-optimization. Besides, the worst case scenario is comparably better than the worst case scenario of the one-phase-optimization strategy. The plan is more cautious supply quantities are reduced leading to lower expected profits but better minimum profits in the worst case scenario. Although robustness is not measured it get s visible in the numerical tests for the 2-phase optimization approach. 

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