{"id":818,"date":"2020-09-01T16:32:38","date_gmt":"2020-09-01T16:32:38","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=818"},"modified":"2024-11-03T15:12:19","modified_gmt":"2024-11-03T15:12:19","slug":"lack-of-assessment-of-automated-test-execution-tools","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/","title":{"rendered":"Lack of Assessment of Automated Test Execution Tools"},"content":{"rendered":"\r\n\r\n\r\n<h4><span style=\"color: #009999;\">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>\r\n<p><!--more--><\/p>\r\n<h5>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, <strong>appropriate assessment of the tool\u00a0 should be carried out before use<\/strong>.<\/h5>\r\n<blockquote>\r\n<h5>The assessment and verification of a computerized test tool should focus on demonstrating that the tool is <strong>fit for purpose<\/strong> as far as critical requirements<\/h5>\r\n<\/blockquote>\r\n<h5>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>\r\n<ul>\r\n<li>\r\n<h5>Security of test data (e.g. role based permissions and user retriction, use of audit trails). The verification should focus on the implementation of security through the use of logical and\/or physical security controls and procedural controls.<\/h5>\r\n<\/li>\r\n<li>\r\n<h5>Enforcement of defined test processes or workflow.<\/h5>\r\n<\/li>\r\n<\/ul>\r\n<h5>Custom or highly configured test automation tools may, based on a risk assessment, require detailed requirements definition, specifications and verification.<\/h5>\r\n<h5>Whether you are a GxP software developer, auditor, inspector or an end user, remember\u00a0 that the test tools used for automated testing of GxP systems are required to be assessed, and that based on that assessment, a verification or testing approach will be defined to demonstrate the tool&#8217;s fit for purpose.<\/h5>\r\n<p>&nbsp;<\/p>\r\n<h3 style=\"text-align: justify;\" align=\"justify\"><strong><span style=\"color: #009999;\">REFERENCES<\/span><\/strong><\/h3>\r\n<ul style=\"list-style-type: circle;\">\r\n<li>\r\n<h6><span style=\"color: #333333;\"><span style=\"font-size: small;\">International Council for Harmonization (ICH): ICH Harmonized Guideline, Integrated Addendum to ICH E6(R1): <\/span><span style=\"font-size: small;\">Guideline for Good Clinical Practice<\/span><span style=\"font-size: small;\"> E6(R2). Step 4, version 9 November 2016. <\/span><\/span><\/h6>\r\n<\/li>\r\n<li>\r\n<h6><span style=\"font-size: small; color: #333333;\">GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems. ISPE. 2012<\/span><\/h6>\r\n<\/li>\r\n<\/ul>\r\n<p>&nbsp;<\/p>\r\n<h4><strong><span style=\"color: #0000ff;\">SIGN UP for our newsletter to stay up to date on all our new articles<\/span><\/strong><br \/><br \/>\ud83d\udc49<span style=\"color: #0000ff;\"> <a style=\"color: #0000ff;\" href=\"https:\/\/www.pharmity.com\/blog\/#newsletter\">https:\/\/www.pharmity.com\/blog\/#newsletter<\/a><\/span><\/h4>\r\n<p align=\"justify\">\u00a0<\/p>\r\n<p style=\"text-align: justify;\" align=\"justify\"><span style=\"color: #009999;\"><span style=\"font-size: medium;\">Author: Dr Leire Z\u00fa\u00f1iga, Director and Principal GCP Consultant<\/span><\/span><\/p>\r\n<p style=\"text-align: justify;\" align=\"justify\"><span style=\"color: #009999;\"><span style=\"font-size: medium;\"><b>PHARMITY<\/b><\/span><\/span><span style=\"color: #009999;\"><span style=\"font-size: medium;\">, 1st of September 2020<\/span><\/span><\/p>\r\n<p style=\"text-align: justify;\" align=\"justify\"><a href=\"http:\/\/www.pharmity.com\/\"><span style=\"font-size: medium;\">www.pharmity.com<\/span><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>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.<\/p>\n","protected":false},"author":3,"featured_media":829,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24,17],"tags":[25],"class_list":["post-818","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-computer-system-validation","category-ich-gcp","tag-csv"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Lack of Assessment of Automated Test Execution Tools | Pharmity<\/title>\n<meta name=\"description\" content=\"Automated test execution tools can be used to improve test execution 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 .\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lack of Assessment of Automated Test Execution Tools | Pharmity\" \/>\n<meta property=\"og:description\" content=\"Automated test execution tools can be used to improve test execution 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 .\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharmity\" \/>\n<meta property=\"article:published_time\" content=\"2020-09-01T16:32:38+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-03T15:12:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.pharmity.com\/wp-content\/uploads\/2020\/09\/Automated-testing-1024x683.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"683\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Leire Zu\u00f1iga\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Leire Zu\u00f1iga\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/\"},\"author\":{\"name\":\"Leire Zu\u00f1iga\",\"@id\":\"https:\/\/www.pharmity.com\/#\/schema\/person\/a44b1c604f6554577cde3888acbaedb4\"},\"headline\":\"Lack of Assessment of Automated Test Execution Tools\",\"datePublished\":\"2020-09-01T16:32:38+00:00\",\"dateModified\":\"2024-11-03T15:12:19+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/\"},\"wordCount\":383,\"publisher\":{\"@id\":\"https:\/\/www.pharmity.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.pharmity.com\/wp-content\/uploads\/2020\/09\/Automated-testing.png\",\"keywords\":[\"CSV\"],\"articleSection\":[\"Computer System Validation\",\"ICH GCP\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/\",\"url\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/\",\"name\":\"Lack of Assessment of Automated Test Execution Tools | Pharmity\",\"isPartOf\":{\"@id\":\"https:\/\/www.pharmity.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.pharmity.com\/lack-of-assessment-of-automated-test-execution-tools\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/www.pharmity.com\/wp-content\/uploads\/2020\/09\/Automated-testing.png\",\"datePublished\":\"2020-09-01T16:32:38+00:00\",\"dateModified\":\"2024-11-03T15:12:19+00:00\",\"description\":\"Automated test execution tools can be used to improve test execution efficiency and effectiveness. 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