{"id":14350,"date":"2026-01-29T15:14:06","date_gmt":"2026-01-29T14:14:06","guid":{"rendered":"https:\/\/q-finity.de\/?p=14350"},"modified":"2026-02-23T11:32:41","modified_gmt":"2026-02-23T10:32:41","slug":"expert-article","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/expert-article\/","title":{"rendered":"Expert Article published in Pharmaceutical Engineering"},"content":{"rendered":"<p data-start=\"0\" data-end=\"232\"><a href=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png\"><img data-opt-id=407893224  fetchpriority=\"high\" decoding=\"async\" class=\" wp-image-14349 alignright\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:251\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png\" alt=\"\" width=\"275\" height=\"329\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:251\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png 251w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:863\/h:1030\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png 863w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:917\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:591\/h:705\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png 591w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:904\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/01\/Bildschirmfoto-2026-01-29-um-15.06.27.png 1002w\" sizes=\"(max-width: 275px) 100vw, 275px\"><\/a>Our expert article &ldquo;How AI Will Transform <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a>&rdquo; has been published in the latest issue of Pharmaceutical Engineering, the journal of the International Society for Pharmaceutical Engineering (ISPE). The article has also been published as a Feature Article on the ISPE website.<\/p>\n<p data-start=\"234\" data-end=\"529\">In this article, Oliver Herrmann and Frank Henrichmann of <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> demonstrate how artificial intelligence can fundamentally transform <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a> (CSV) in regulated GxP environments &mdash; from requirements definition and risk assessment to test creation and execution.<\/p>\n<h3 data-start=\"531\" data-end=\"953\">Key message:<\/h3>\n<p data-start=\"531\" data-end=\"953\"><br data-start=\"547\" data-end=\"550\">AI accelerates CSV not by replacing expertise, but by purposefully supporting it. Based on clearly defined business processes, AI analyzes relevant inputs and helps generate precise user requirements, structured risk assessments, and robust test cases. Using a human-in-the-loop approach, qualified AI tools can simultaneously increase the speed, consistency, and <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> of validation deliverables.<\/p>\n<h3 data-start=\"955\" data-end=\"982\">The article also addresses:<\/h3>\n<ul data-start=\"983\" data-end=\"1266\">\n<li data-start=\"983\" data-end=\"1087\">\n<p data-start=\"985\" data-end=\"1087\">the evolution of roles within validation teams (from document management to <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> architecture),<\/p>\n<\/li>\n<li data-start=\"1088\" data-end=\"1158\">\n<p data-start=\"1090\" data-end=\"1158\">the regulatory guardrails that must be considered when using AI,<\/p>\n<\/li>\n<li data-start=\"1159\" data-end=\"1266\">\n<p data-start=\"1161\" data-end=\"1266\">and key challenges such as regulatory acceptance, qualification of AI systems, and change management.<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1268\" data-end=\"1368\">We would like to thank ISPE for providing the platform and for initiating this important discussion.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Our expert article \u201cHow AI Will Transform Computerized System Validation\u201d has been published in the latest issue of Pharmaceutical Engineering, the journal of the International Society for Pharmaceutical Engineering (ISPE). The article has also been published as a Feature Article on the ISPE website. In this article, Oliver Herrmann and Frank Henrichmann of QFINITY demonstrate [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-14350","post","type-post","status-publish","format-standard","hentry","category-news-category"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Expert Article published in Pharmaceutical Engineering<\/title>\n<meta name=\"description\" content=\"Our expert article \u201cHow AI Will Transform Computerized System Validation\u201d has been published in the Pharmaceutical Engineering.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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