Testing software environment

PQ is always required to test software in the production environment... 

After evaluation and acceptance, the change can be effected, tested (if applicable), and formally commissioned into use. This principle applies equally to hardware and software in the case of the latter, code redevelopment and testing should follow the same procedure as newly developed software. It is wise, if possible, to develop and test such changes in an isolated test/development environment before applying the change to the operational system. 

Testing consumes a large part of the software life cycle and its budget. Engineers use software tools such as test generators and test execution environments to try to control these costs. 

To evaluate the performance of the proposed Braille display, psychophysical tests have been performed using visually impaired persons. Seven individuals participated in the test, six of them were males and one was a female with an overall average age of 32.6 years. All of them were employees of the Korean Assoeiation of the Visually Impaired. One of them had weak vision and the others were completely blind. The software environment graphical... 

However, these requirements go further than merely controlling the devices used for measurement. They address the measurements themselves, the selection of the devices for measurement and also apply to devices which create product features, if they are used for product verification purposes. If you rely on jigs, tools, fixtures, templates, patterns, etc. to form shapes or other characteristics and have no other means of verifying the shape achieved, these devices become a means of verification. If you use software to control equipment, simulate the environment or operational conditions, or carry out tests and you rely on that software doing what it is supposed to do, without any separate means of checking the result, the quality of such software becomes critical to product verification. In fact the requirements apply to metrology as a whole rather than being limited to the equipment that is used to obtain the measurement and therefore a more appropriate title of the section would be Control of measurements . 

Despite its weaknesses (such as described in the 1975 collection of essays The Mythical Man Month [11]), the traditional software development life cycle (collect requirements, design, implement, test, deploy, maintain) has remained the standard framework for software development. However, in recent years it has become clear that the life cycle is not well suited to applications that are experimental in nature (i.e., where there is no precedent for the particular kind of application) or that exist in rapidly changing environments. This has led to the development of agile methodologies (also known as lightweight... 

Testing must be conducted in a typical end-user environment, or in a simulated end-user environment, identical with the environment where the software/computer system will be used. Documentation of testing can be recorded as raw data, such as in a logbook, and should include the parameters tested, and the results of testing. The data should be tabulated as a final report document that includes all details included in the test plan, their execution, the results, and conclusions. The final report document must be signed by appropriate personnel, reviewed as needed, and archived. Upon successful completion of testing, the software/computer system can be released for testing and use in an actual end-user environment. 

The CFR 21 part 11 compliant software newly released by Convergent Bioscience makes imaged cIEF a viable technique for use in QC environments for release testing of therapeutic proteins or antibody molecules. i-cIEF has also been used heavily for characterization of protein modifications such as deamidation and isomerization, as well as oligosaccharide structure analysis. ... 

Intermediate Precision. Intermediate precision expresses within-laboratory variation and is generally performed on different days using different analysts, equipment, and sample preparations. This test may not be applicable if the laboratory has only one workstation. Additionally, this test may not be appropriate for automated workstations that are operating under the same environment and controls within a laboratory. This assumption is made on the basis that the automated workstations are identical (i.e., same configuration, same software and hardware) and that they have been suitably qualified and maintained to a consistent standard and operate under a similar climatic environment. The influence of the analyst is reduced to the preparation of solvents, and this should be covered by the robustness studies. 

GMP risk assessment Qualified/trained resource System life-cycle validation System environment Current specifications Software quality assurance Formal testing/acceptance Data entry authorization Data plausibility checks Communication diagnostics Access security Batch release authority Formal procedures/contracts Change control Electronic data hardcopy Secure data storage Contingency/recovery plans Maintenance plans/records... 

The FAT is normally a contractual acceptance test that serves to ensure that within the limitations of testing available at the supplier s premises the system operates satisfactorily, and for any problems identified during testing has the advantage of being directly resourced and resolved in the development environment. Problems (particularly software-related) carried over or detected on site are invariably more difficult and time-consuming to rectify. 

Numerous inspection steps undertaken throughout the system development and operational life support that a computer system is validated. These include static analyses such as document and code inspections, walk-through, and technical reviews. These activities and their outcomes help to reduce the amount of system level functional testing needed at the operational environment to confirm that software meets requirements and intended uses. 

In all large and complex systems developed by contract developers, it is normally the practice to perform an SAT. The SAT is the set of activities comprising the system installation, start-up, operational testing, and user orientation performed by the software supplier/integrator in the operational environment. For the purposes of this book, the operational testing performed as part of the SAT is also known as the OQ2. If the SAT is conducted according to approved protocols, test results are properly documented, and test results reviewed and approved by the user and QA, it may not be necessary to repeat the installation and operational qualifications. This provides cost savings and can streamline the validation process. Refer to Sidebar 10-2. 

In a mature software development environment, software is developed as individual components or small units. Each unit is tested individually and integrated with other units to form a module. The accurate implementation of each module is achieved by following the technical design specification deliverable. The output of the software development process is an assembled system. 

The FAT provides evidence that the hardware and software are fully integrated, that they operate as indicated in the computer system specification deliverable, and meet the expectations of the user as defined in the requirements specification deliverable. This final formal integration test should be completed in an environment very similar to the operational environment. The system can be subjected to a real-world environment by using emulators and/or simulators which mimic system interfaces. The user s representative should evaluate the supporting documents, the operation, system functionality, and system reliability. 

The testing carried out in the development environment is not sufficient to verily the integrity and performance of the system. The application software must also be tested under actual conditions of intended use in the target or production environment. If the application is to be supplied by a third party in accordance with the end-user s requirements specification deliverable, it should be possible to carry out a completely prospective validation, as would be the case for a system developed in house, providing the requirement for validation is identified at the beginning. As with all systems, the responsibility for validation lies with the system s owner. 

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