GAMP – Test Management Tools, Coverage & Traceability

  GAMP – Test Management Tools

This article was written by Ilan Shaya a world specialist in validation, automation & control

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 and computerized systems

:Such tools generally improve the efficiency of test processes, by managing activities such as

Requirements traceability

Test script development, review and approval

Test planning

Test execution, including automatically running test cases

Test results, and test evidence capture and management

Test case review

Test incident management

Overall test management using test monitoring tools

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

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, Appendix M4

:The use of such tools is recommended for organizations that

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

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

                          Test Coverage and Traceability

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

It is important to initiate requirements traceability as early as as possible in the project, typically after URS approval

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.

:A Requirement Traceability Matrix (or equivalent provides the following benefits for testing

Documented test coverage of all critical (GxP) requirements

Determination of specific testing documents that require updating as a result of changes

Reduction of redundancy (and, thus, of effort) in Test Specifications or Protocols

Ease of presentation to regulators, in order to demonstrate the completeness of testing within the development process of an application

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