ולידציה - GAMP - Test Execution - part 2
The execution of a test using automated (computerized) test tools.
פורסם:
GAMP -Automated Test Execution and Computerized Test Management Tools As I've promised on my last post - Good Automated Manufacturing Practice (GAMP) Test Execution - part 1 I will now continue to elaborate on the execution of a test using automated (computerized) test tools. These tools should be conducted in accordance with the Test Plan or Strategy. This should require that all automated tools used to test GxP systems have been subjected to assessment and appropriate validation prior to their use, in order to establish s a high degree of assurance that they will perform as intended, and return accurate and secure results. Before discussing the benefits and use of automated test tools, it is useful to describe the difference between a computerized test management tool and automated testing. A computerized test management tool facilitates the task of Test Case and Test Script authoring, review and approval (pre and post execution), test execution, and test deviation management. This is accomplished using workflow enabled processes, electronic test artifact management (i.e., Test Cases, Test Scripts, Deviation Reports), and possibly electronic signatures. However, even with computerized test management, the actual test execution is performed by the tester, even when this task is aided by the presentation of on-screen test scripts and electronic capture of test evidence. The tester must still manually follow the test steps, provide inputs to the system under test, and record the test evidence. With automated test execution, the computerized test tool also executes the actual test and records the test evidence. This can significantly reduce the test execution time. Because most automated test execution is based upon initial manual test execution (where the tool often 'records' the manual actions of the tester), automated testing is most often used when executing tests during a second test cycle and is well sited to regression testing. Benefits of Computerized Test Management Tools and Automated Test Execution When planned properly, automating the test activities can bring considerable benefits within the project life cycle. However, if poorly planned, computer based tools and test automation may be difficult, complex, and time consuming task, with little or no return on investment. Computerized test management tools can significantly reduce the amount of paper used during testing and provide helpful test management support. This includes the ability to report on the test activities status and facilitate test activities using workflow. In most large testing projects, the use of such tool can reduce testing timescales. Not every aspect of a computerized system can be automatically tested. A key factor in the successful use of such tools is the early identification of the types of tests that should be automated, and the types of tests to be executed manually. While computerized test management tools and automated testing can both provide benefits, they should be considered separately. Some project may benefit from the use of computerized test management tools, but may derive little benefits using automated test tools. Before deciding on the usefulness of computerized test management and automated test tools, the following points should be considered: Will the tools be used in a single project or more broadly within the organization? Typically in a large project or organization, a wide use is necessary to provide return on investment. How many test cycles are typically executed, and how much regression testing is required? This will help determine the need for automated testing. Will the tool be used by a dedicated test team, or in all projects? This has an impact on on-going administration and training requirements. The use of computerized test management and automated test tools need to be regarded as a SW development activity that has its own life cycle. These tools will have their own implementation and validation life cycle. This will place additional requirements on the test team, particularly in terms of the skills required by test script developers. The use of these tools is only effective if supported by adequate processes and if the staff has the necessary skills to use the tools effectively. The usability of a test tool is significantly enhanced if it is application-interdependent (i.e., used to test multiple application). Easy maintenance of a test suite is crucial for a successful implementation of an…