Code evaluation report

Cmcial documentation needed in the development phase includes end-user manuals, a unit test summary report, a user acceptance test plan, results of the database design, results and methods employed in the source code evaluations, and a trace-ability analysis. A source code traceability analysis verifies that all code is linked to established specifications and established test procedures. 

All acquired software should be evaluated, reviewed, or tested by GE responsible engineers in design team based on relevant code or standard prior to use. Also, these evaluation reports will be submitted to GE IVVT for review. 

The code evaluation should culminate in a report to management which outlines the deficiencies of the facility, addresses potential compliance strategies, quantifies potential cost and recommends a plan of action. Some code requirements may not be mandatory, but should be done, nevertheless, to limit corporate liability and mitigate danger to life and property. 

Kada, T. (1981). The DNA damaging activity of 42 coded compounds in the Rec-assay. In Evaluation of Short-term Tests for Carcinogens. Report of the International Collaborative Program (de Serres F. and Ashby J., Eds.). Elsevier/North Holland, Amsterdam, pp. 175— 182. 

European Union (EU). The European Agency for the Evaluation of Medical Products (EMEA) established January 2002 as the deadline for all electronically filed single case reports to be coded in MedDRA. All ADR drug reporting must be coded in MedDRA by January 2003. 

Kee, R. J., Dixon-Lewis, G., Warnatz, J., Coltrin, M. E., and Miller, J. A., A Fortran Computer Code Package for the Evaluation of Gas-Phase Multicomponent Transport, Sandia Report, SAND86-8246 (1986). 

Similarly, ethos, the testimonial dependent upon the expertise and credibility of the witness, is critical. Evidence supplied by an impartial and credentialed observer may estabhsh comphance with control standard operating procedures (SOPs), accuracy of documentary evidence, and suitability of code design. Whereas the accuracy of logos transcends its interpretation, however, ethos proof must be evaluated on the basis of its source. Who said so , How does he or she know , and Why should he or she be trusted become the key questions. It is upon the importance of ethos that the important issues of independent, quality assurance (QA), and confirmatory investigation hes. Most ethos testimony takes the form of reports, observational records, and certifications. 

The six areas of proof previously discussed also provide a comprehensive package of evidence in support of the GALP. Each area is supported with specific documentary evidence, such as test results, SOPs, manuals, and code, and with testimonial evidence in the form of evaluations, interpretations, and summary reports. 

MacDonald, D.J. (1981) SalmonellalMiciosome tests on 42 coded chemicals. In de Senes, F.J. Ashby, J., eds, Progress in Mutation Research, Volume 1, Evaluation of Short-Term Tests for Carcinogens. Report of the International Collaborative Program, Amsterdam, Elsevier Science, pp. 285-297... 

Parry, J.M. Sharp, D.C. (1981) Induction of mitotic aneuploidy in the yeast strain D6 by 42 coded compounds. In de Series, F.J. Ashby, J., eds, Progress in Mutation Research, Volume 1, Evaluation of Short-Term Tests for Carcinogens. Report of the International Collaborative Program, Amsterdam, Elsevier Science, pp. 468-480 Parry, E.M. (1985) Tests for effects on mitosis and the mitotic spindle in Chinese hamster primary liver cells (CHl-L) in culture. In Ashby, J., de Serres, F.J., Draper, M., Ishidate, M., Jr, Margolin, B.H., Matter, B.E. Shelby, M.D., eds. Progress in Mutation Research, Volume 5, Evaluation of Short-Term Tests for Carcinogens. Report of the International Programme on Chemical Safety s Collaborative Study on in vitro assays, Amsterdam, Elsevier Science, pp. 479-485... 

A demonstration of this approach has been reported to evaluate the ability of a lattice-Boltzmann code to predict both spatially resolved flow fields and MR propagators characterizing flow through random packings of spheres (model fixed beds) for flows defined by Peclet (Pe) and Reynolds numbers in the range 182 < Pc <3 50 and 0.4 < Re <0.77 (85). Excellent agreement was found between the numerical predictions and experimental measurements. Current interest in this field addresses the validation and development of numerical codes predicting flows at Reynolds numbers more appropriate to real catalytic reactors. 

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