{"id":35492,"date":"2015-10-12T05:53:30","date_gmt":"2015-10-12T02:53:30","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35492"},"modified":"2015-10-12T05:53:30","modified_gmt":"2015-10-12T02:53:30","slug":"gamp-test-management-tools-coverage-traceability","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/en\/gamp-test-management-tools-coverage-traceability\/","title":{"rendered":"GAMP – Test Management Tools, Coverage & Traceability"},"content":{"rendered":"

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\u00a0 GAMP – Test Management Tools<\/h2>\n
\"\u05d0\u05d9\u05dc\u05df<\/a>
Ilan Shaya CEO , control and automation specialist and designer<\/figcaption><\/figure>\n

This article was written by Ilan Shaya a world specialist in validation, automation & control<\/h4>\n

Computerized test management tools are extremely useful for testing large or complex systems, or in organizations where there is need for ongoing testing of SW<\/a> and computerized systems<\/a><\/p>\n

:Such tools generally improve the efficiency of test processes, by managing activities such as<\/p>\n

Requirements traceability<\/p>\n

Test script development, review and approval<\/p>\n

Test planning<\/p>\n

Test execution<\/a>, including automatically running test cases<\/p>\n

Test results, and test evidence capture and management<\/p>\n

Test case review<\/p>\n

Test incident management<\/p>\n

Overall test management using test monitoring tools<\/p>\n

Most modern test management tools provide the ability to configure test process workflows and user roles, and significantly reduce the need for paper based test records<\/p>\n

For use in pharmaceutical and related industries, such test management should be properly verified and the integrity of test records should be assured. See GAMP 4<\/a>, Appendix M4<\/p>\n

:The use of such tools is recommended for organizations that<\/p>\n

Implement large or complex system with potential multiple rounds of regression testing during the system life cycle such as ERP, LIMS or desktop client images<\/p>\n

Develop expertise in testing computers and SW across all business areas, and have an opportunity to develop expertise in the use and support of a test management tool<\/p>\n

\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 Test Coverage and Traceability<\/h2>\n

The Test Plan or Strategy should require clear, documented traceability between the requirements outlined in the controlling specifications and undertaken tests. This traceability, once completed, should demonstrate that every stated has been tested, and show the mutual correspondence between the items<\/p>\n

It is important to initiate requirements traceability as early as as possible in the project, typically after URS\u00a0approval<\/p>\n

Traceability to requirements should be maintained at the Test Case or Test Script level. If the test covers multiple requirements, further breakdown within the test steps may be considered to demonstrate where a specific requirement is tested.<\/p>\n

:A Requirement Traceability Matrix (or equivalent provides the following benefits for testing<\/p>\n

Documented test coverage of all critical (GxP) requirements<\/p>\n

Determination of specific testing documents that require updating as a result of changes<\/p>\n

Reduction of redundancy (and, thus, of effort) in Test Specifications or Protocols<\/p>\n

Ease of presentation to regulators, in order to demonstrate the completeness of testing within the development process of an application<\/p>\n

Not all requirements may be traceable to Test Case or Test Script. Some requirements may be verified instead of tested, but verification activities and documents can also be included in requirement traceability – see GAMP 4, Appendix M5, for further details<\/p>\n