{"id":818,"date":"2020-09-01T16:32:38","date_gmt":"2020-09-01T16:32:38","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=818"},"modified":"2020-09-01T16:32:41","modified_gmt":"2020-09-01T16:32:41","slug":"lack-of-assessment-of-automated-test-execution-tools","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=818","title":{"rendered":"Lack of Assessment of Automated Test Execution Tools"},"content":{"rendered":"\n\n\n\n

Automated test execution tools can be used to improve efficiency and effectiveness. Like other software, test automation software may be standard, configurable, or custom, and should be specified and verified appropriately based on an assessment of risk; however, auditors frequently note that GxP software developers do not assess these tools before using them.<\/span><\/h4>\n

<\/p>\n

Commercial or established tools are considered to be GAMP Software Category 1 and ussually have a low impact on product quality or patient safety; therefore, they are considered to have a low risk priority and do not typically need to be validated. However, appropriate assessment of the tool\u00a0 should be carried out before use<\/strong>.<\/h5>\n
\n
The assessment and verification of a computerized test tool should focus on demonstrating that the tool is fit for purpose<\/strong> as far as critical requirements<\/h5>\n<\/blockquote>\n
The level of required verification depends on the nature of the tool and the degree of configuration and customization. Typically if a well known and accepted tool is used, a proof of its fitness for the intended purpose would be enough. This proof should focus on the critical requirements, including:<\/h5>\n