{"id":14350,"date":"2026-01-29T15:14:06","date_gmt":"2026-01-29T14:14:06","guid":{"rendered":"https:\/\/q-finity.de\/?p=14350"},"modified":"2026-07-19T08:59:56","modified_gmt":"2026-07-19T06:59:56","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\">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). It also appears 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 QFINITY demonstrate how artificial intelligence can fundamentally transform <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components,&hellip;\" class=\"encyclopedia\">Computerized System<\/a> Validation (CSV) in regulated GxP environments &ndash; 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 quality 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 quality 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<p><a class=\"qf-extref\" href=\"https:\/\/ispe.org\/pharmaceutical-engineering\/january-february-2026\/how-ai-will-transform-computerized-system\" target=\"_blank\" rel=\"noopener\"><span class=\"qf-extref-text\">Read the article at Pharmaceutical Engineering (ispe.org)<\/span><span class=\"qf-extref-arrow\">&#8599;<\/span><\/a><\/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). It also appears as a Feature Article on the ISPE website. In this article, Oliver Herrmann and Frank Henrichmann of QFINITY demonstrate how artificial intelligence [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":14346,"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","has-post-thumbnail","hentry","category-news-category"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>How AI Transforms Computerized System Validation | QFINITY<\/title>\n<meta name=\"description\" content=\"QFINITY&#039;s article in ISPE Pharmaceutical Engineering: how AI-enabled tools are reshaping Computerized System Validation in GxP environments.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/expert-article\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How AI Transforms Computerized System Validation | QFINITY\" \/>\n<meta property=\"og:description\" content=\"QFINITY&#039;s article in ISPE Pharmaceutical Engineering: how AI-enabled tools are reshaping Computerized System Validation in GxP environments.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/expert-article\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-29T14:14:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-19T06:59:56+00:00\" \/>\n<meta property=\"og:image\" 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