Testing Documentation

There is no right or wrong way to document the planning and execution of testing but a number of artefacts have become common over the years underpinned by the requirements in a number of different software testing standards. These artefacts are important inputs into the team developing the safety case. 

Traceability matrix - Provides logical linkage between the different components of testing. For example, traceability between the system s requirements and the test cases offers a means of evidencing completeness. When this is also linked to the defects found a rounded, logical picture of the system s validation can be demonstrated. 

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We are confident that any user of this combined evaluation technique, as well as the development of future test standards for manual ultrasonic testing will benefit from this result, because it allows a greater flexibility in the applicable method without loosing reliability. Often an expensive production of a reference block can be avoided and therefore testing costs are reduced. Since all calculations are performed by a PC, the operator can fully concentrate on his most important duty scanning the workpiece and observing the A-scan. Additional time will be saved for the test documentation, since all testing results are stored in the instrument s memory (the PC s hard drive) with full link to the Software World (Microsoft Word, Excel, etc.). 

The quality of the product can only be verified by the subcontractor during its design and manufacture. (In such cases you need to rely on what the contractor tells you and to gain sufficient confidence you can impose quality system requirements, require certain design, manufacturing, inspection, and test documents to be submitted to you for approval, and carry out periodic audit and surveillance activities. This method is usually applied for one-off systems or small quantities when the stability of a long production run cannot be achieved to resolve problems.)... 

Processes in this context means those series of related activities that turn inputs into outputs of added value. They include design, procurement, manufacture, packing, delivery, installation, maintenance, operations, disposal as well as the processes which serve these primary processes such as calibration, training, inspection, test, document control, etc. 

In contrast to the steric effoits, the purely electronic influences of substituents are less clear. They are test documented by linear free-energy relationships, which, for the cases in question, are for the most part only plots of voltammetrically obtained peak oxidation potentials of corresponding monomers against their respective Hammett substituent constant As a rule, the linear correlations are very good for all systems, and prove, in aax>rdance with the Hammett-Taft equation, the dominance of electronic effects in the primary oxidation step. But the effects of identical substituents on the respective system s tendency to polymerize differ from parent monomer to parent monomer. Whereas thiophenes which receive electron-withdrawing substituents in the, as such, favourable P-position do not polymerize at all indoles with the same substituents polymerize particularly well... 

Examples of test data sets available (e.g., test scripts or automated test tools that would be suitable for version purchased) Boundary/stress/unexpected input tests Structural/functional testing (documentation of walkthroughs, etc.)... 

Activities encompassed by the stability program include sample storage of either development or production batches (or both), data collection and storage/retrieval, physical, chemical, and microbiological testing, document preparation of regulatory... 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

In acute hepatitis C, the rate of clearance of the virus without therapy is estimated at 15-30%. In one (uncontrolled) study, treatment of acute infection with interferon alfa-2b, in doses higher than those used for chronic hepatitis C (Table 49-6), resulted in a sustained rate of clearance of 95% at 6 months. Therefore, if HCV RNA testing documents persistent viremia 12 weeks after initial seroconversion, antiviral therapy is recommended. 

Level Classification Therapeutic Range Test Documentation Filing Documentation... 

The test chapter section will include information about purpose, test documentation, review and approval, formal test plan, and test execution. Testing the spreadsheet should take all requirements into account. Tests using known cases and data including known results have to be developed. The data set used for testing should include representative data. If applicable, tests should also include data sets that will test values that exceed the anticipated range of normal operations and check for data close to the acceptance criteria limits. Data that make no sense (text in a numeric field) or are not allowed to be used in the calculation should be considered in the testing phase as well. The simplest test to validate a spreadsheet calculation is to perform a manual calculation and document it. All tests performed, results expected, acceptance criteria for the tests, and procedures for alternative calculation (e.g., manual calculation) will have to be documented. Persons who perform the testing have to be trained appropriately and must be mentioned in the documentation. 

Level 2 changes are those that could have a significant impact on fonnulation quality and perfonnance. Test documentation for a level 2 change would vary de-... 

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