{"id":13176,"date":"2024-07-08T19:59:37","date_gmt":"2024-07-08T17:59:37","guid":{"rendered":"https:\/\/q-finity.de\/?page_id=13176"},"modified":"2026-02-25T17:52:54","modified_gmt":"2026-02-25T16:52:54","slug":"artificial-intelligence","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/artificial-intelligence\/","title":{"rendered":"Artificial intelligence"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd98wjo-ec1181bfc6a9b82a93c89f6ec31a4b64\">\n.avia-section.av-lyd98wjo-ec1181bfc6a9b82a93c89f6ec31a4b64{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bild-KI-3.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id=\"av_section_1\" class=\"avia-section av-lyd98wjo-ec1181bfc6a9b82a93c89f6ec31a4b64 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-minimum-height av-minimum-height-50 av-height-50  container_wrap fullsize\" data-section-bg-repeat=\"stretch\" data-av_minimum_height_pc=\"50\" data-av_min_height_opt=\"50\"><div class=\"container av-section-cont-open\"><main role=\"main\" itemprop=\"mainContentOfPage\" class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e\">\n#top .av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:50px;\n}\nbody .av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-lyd9aczb-32c00953f107a60cb7485da82d37ad9e av-special-heading-h1 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-1  avia-builder-el-no-sibling  av-inherit-size\"><h1 class=\"av-special-heading-tag \" itemprop=\"headline\">Artificial intelligence in the GxP-regulated environment <\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><div id=\"av_section_2\" class=\"avia-section av-av_section-8c038a69d7b065b313c8996090138e7a main_color avia-section-default avia-no-border-styling  avia-builder-el-2  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-3  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd9bm16-1f734a74b3a574e5c111fbb3f3de41d1\">\n#top .av-special-heading.av-lyd9bm16-1f734a74b3a574e5c111fbb3f3de41d1{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lyd9bm16-1f734a74b3a574e5c111fbb3f3de41d1 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd9bm16-1f734a74b3a574e5c111fbb3f3de41d1 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd9bm16-1f734a74b3a574e5c111fbb3f3de41d1 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lyd9bm16-1f734a74b3a574e5c111fbb3f3de41d1 av-special-heading-h2  avia-builder-el-4  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Deploying AI safely and effectively &mdash; between GxP, the EU AI Act, and operational reality <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lyd9crra-fbf0cf439793143bf4254695efb01533 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p><span data-contrast=\"none\">Are you already using AI in&nbsp;GxP-relevant processes &mdash; or&nbsp;planning to?<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">Then you are not just introducing&nbsp;a new&nbsp;technology.<\/span><br>\n<span data-contrast=\"none\">You are changing the organization, processes, and the working environment of your employees.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">Artificial intelligence is transforming pharma, biotechnology, and medical technology. Processes become more efficient, <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> analyses more powerful, and decision support more&nbsp;precise. At the same time, new regulatory requirements are emerging &mdash; especially where AI has a direct impact on product <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>, patient&nbsp;<\/span><span data-contrast=\"none\">rights &amp;&nbsp;<\/span><span data-contrast=\"none\">safety, or <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">Between innovation pressure, the EU AI Act, and&nbsp;GxP&nbsp;requirements, a new level of complexity is taking shape. Without a structured framework, this either leads to operational paralysis &mdash; or increased regulatory risk.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\"><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> supports you in introducing and operating AI systems in a compliant, risk-based, and value-creating way &mdash; practical and future-oriented.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-6  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd9eino-06bc65200c99ebf8a3a5719a52b45002\">\n.avia-section.av-lyd9eino-06bc65200c99ebf8a3a5719a52b45002{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bild-KI-3.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_3\" class=\"avia-section av-lyd9eino-06bc65200c99ebf8a3a5719a52b45002 main_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_section  el_before_av_section  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-8  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-9  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd9gkgs-500e339a063635e42b9fe74e63529635\">\n#top .av-special-heading.av-lyd9gkgs-500e339a063635e42b9fe74e63529635{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-lyd9gkgs-500e339a063635e42b9fe74e63529635 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd9gkgs-500e339a063635e42b9fe74e63529635 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd9gkgs-500e339a063635e42b9fe74e63529635 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lyd9gkgs-500e339a063635e42b9fe74e63529635 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lyd9gkgs-500e339a063635e42b9fe74e63529635 av-special-heading-h2 custom-color-heading  avia-builder-el-10  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">AI in a GxP-regulated environment is more than just software <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd9i0hj-c53996083667203172e2f782969dbfea\">\n#top .av_textblock_section.av-lyd9i0hj-c53996083667203172e2f782969dbfea .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section class=\"av_textblock_section av-lyd9i0hj-c53996083667203172e2f782969dbfea \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><p><span data-contrast=\"none\">In regulated environments, we do not view AI&nbsp;as an isolated&nbsp;application, but as a subsystem of an overarching <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is 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, together&hellip;\" class=\"encyclopedia\">computerized system<\/a>.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">Regulatory and economic viability only&nbsp;emerges&nbsp;through the interaction of:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">AI&nbsp;models&nbsp;and&nbsp;algorithms<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">IT&nbsp;systems,&nbsp;infrastructure, and&nbsp;interfaces<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Business&nbsp;processes&nbsp;and SOPs<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\"><a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a> <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>,&nbsp;IT&nbsp;and information security<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Clearly defined roles and governance structures<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Qualified personnel<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Structured development, change&nbsp;management, and operational processes and\/or effective collaboration with suppliers<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">Only this holistic perspective&nbsp;provides a foundation for&nbsp;stability.<\/span><span data-contrast=\"none\">&nbsp;<\/span><br>\n<span data-contrast=\"none\">Isolated measures do&nbsp;not.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_4\" class=\"avia-section av-av_section-8c038a69d7b065b313c8996090138e7a main_color avia-section-default avia-no-border-styling  avia-builder-el-12  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-13  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29obh3-fdda5953ced63ab0e184c8552bb1b02b\">\n#top .av-special-heading.av-mm29obh3-fdda5953ced63ab0e184c8552bb1b02b{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-mm29obh3-fdda5953ced63ab0e184c8552bb1b02b .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-mm29obh3-fdda5953ced63ab0e184c8552bb1b02b .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-mm29obh3-fdda5953ced63ab0e184c8552bb1b02b .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-mm29obh3-fdda5953ced63ab0e184c8552bb1b02b av-special-heading-h2  avia-builder-el-14  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Leveraging opportunities &mdash; managing risks <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-mm29oyny-7ca008d9a628f1f7ca5abe615875ad91 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p><span data-contrast=\"none\">AI unlocks significant potential, including:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Efficiency gains in <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>- and documentation-intensive processes<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Advanced <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> analytics and new insights<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Support across the entire product lifecycle<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">At the same time, specific risks arise, such as:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\"><a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a>&nbsp;dependency&nbsp;and&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a>&nbsp;<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><\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">AI model&nbsp;behavior and the traceability of results and decisions<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Greater operational dynamics&nbsp;regarding&nbsp;changes in production use<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">New requirements for infrastructure and monitoring<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">&hellip; and&nbsp;many&nbsp;more<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">Regulatory expectations in the&nbsp;GxP&nbsp;context are of particular importance. AI systems that affect&nbsp;GxP-relevant processes are subject to the same requirements as&nbsp;established&nbsp;computerized systems&mdash;supplemented by&nbsp;additional&nbsp;regulatory expectations in the&nbsp;GxP&nbsp;context as well as horizontal regulation such as the EU AI Act.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-16  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-fa708d047516d350251f23d4137c1cf5\">\n.avia-section.av-av_section-fa708d047516d350251f23d4137c1cf5{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bild-KI-3.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_5\" class=\"avia-section av-av_section-fa708d047516d350251f23d4137c1cf5 main_color avia-section-default avia-no-border-styling  avia-builder-el-17  el_after_av_section  el_before_av_section  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-18  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-19  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1\">\n#top .av-special-heading.av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-mm29pk1q-b4c1903165a31153da40de4e3ec929f1 av-special-heading-h2 custom-color-heading  avia-builder-el-20  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Two regulatory perspectives &mdash; one integrated solution<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29q0l5-3a8d130e30bb513322f0b61d4dd1062c\">\n#top .av_textblock_section.av-mm29q0l5-3a8d130e30bb513322f0b61d4dd1062c .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section class=\"av_textblock_section av-mm29q0l5-3a8d130e30bb513322f0b61d4dd1062c \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><p><span data-contrast=\"none\">The use of AI must be assessed from two different perspectives:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><b><span data-contrast=\"none\">GxP&nbsp;risk assessment<\/span><\/b><br>\n<span data-contrast=\"none\">Evaluation of impacts on patient&nbsp;rights\/safety, product <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>, and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>. Based on this, risk-based decisions are made on lifecycle activities and control measures.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><b><span data-contrast=\"none\">Risk classification under the EU AI Act<\/span><\/b><br>\n<span data-contrast=\"none\">Classification based on intended purpose and area of use&mdash;independent&nbsp;of&nbsp;the technical implementation. Certain applications are considered high-risk AI systems if they are classified accordingly.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">These&nbsp;different frameworks&nbsp;can lead to different risk assessments.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\"><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> integrates both perspectives within a consistent governance and lifecycle architecture.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_6\" class=\"avia-section av-av_section-8c038a69d7b065b313c8996090138e7a main_color avia-section-default avia-no-border-styling  avia-builder-el-22  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-23  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29qjoi-023ec69099a6f9acaca80ea398084bf3\">\n#top .av-special-heading.av-mm29qjoi-023ec69099a6f9acaca80ea398084bf3{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-mm29qjoi-023ec69099a6f9acaca80ea398084bf3 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-mm29qjoi-023ec69099a6f9acaca80ea398084bf3 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-mm29qjoi-023ec69099a6f9acaca80ea398084bf3 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-mm29qjoi-023ec69099a6f9acaca80ea398084bf3 av-special-heading-h2  avia-builder-el-24  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Practical experience from real-world AI use cases<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-mm29qzhc-139a3d956c8c94aa858e80dc2b27b0a9 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p><span data-contrast=\"none\">We have been supporting AI implementations in regulated environments for several years, including:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">AI-assisted image analysis in clinical applications<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Visual&nbsp;inspections&nbsp;in&nbsp;pharmaceutical&nbsp;manufacturing<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Yield&nbsp;optimization&nbsp;in&nbsp;pharmaceutical&nbsp;production<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Generative AI applications in deviation management<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">LLM-based&nbsp;support in&nbsp;pharmacovigilance<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"4\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Post-market surveillance in medical technology<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">The greater the impact on patients or product <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>, the higher the requirements for governance, validation, and monitoring.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-26  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-fa708d047516d350251f23d4137c1cf5\">\n.avia-section.av-av_section-fa708d047516d350251f23d4137c1cf5{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bild-KI-3.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_7\" class=\"avia-section av-av_section-fa708d047516d350251f23d4137c1cf5 main_color avia-section-default avia-no-border-styling  avia-builder-el-27  el_after_av_section  el_before_av_section  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-28  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-29  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29rkr6-593cade7178d828dbee66fc07055a0cb\">\n#top .av-special-heading.av-mm29rkr6-593cade7178d828dbee66fc07055a0cb{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-mm29rkr6-593cade7178d828dbee66fc07055a0cb .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-mm29rkr6-593cade7178d828dbee66fc07055a0cb .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-mm29rkr6-593cade7178d828dbee66fc07055a0cb .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-mm29rkr6-593cade7178d828dbee66fc07055a0cb .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-mm29rkr6-593cade7178d828dbee66fc07055a0cb av-special-heading-h2 custom-color-heading  avia-builder-el-30  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">CSV is necessary &mdash; but not sufficient <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29sa9m-d4510ef2b55ce21a6b027efbe7935622\">\n#top .av_textblock_section.av-mm29sa9m-d4510ef2b55ce21a6b027efbe7935622 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section class=\"av_textblock_section av-mm29sa9m-d4510ef2b55ce21a6b027efbe7935622 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><p><span data-contrast=\"none\">Validation activities are a core&nbsp;component. Successful AI implementations additionally require:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">A clear definition of the intended purpose<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Appropriate, well-justified&nbsp;acceptance&nbsp;criteria<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">A traceable&nbsp;selection&nbsp;of <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a>, e.g.,&nbsp;regarding&nbsp;training, validation, and test datasets<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Transparency of design and implementation decisions<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"5\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Controlled&nbsp;changes&nbsp;and&nbsp;continuous&nbsp;monitoring<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">In addition, the following are critical:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Structured&nbsp;change&nbsp;management<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Clear&nbsp;roles&nbsp;and&nbsp;qualifications<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Ongoing development of the <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services. If you need&hellip;\" class=\"encyclopedia\">quality management<\/a> system<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">A robust understanding of <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> and IT security<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Aligned expectations between suppliers and the regulated user<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_8\" class=\"avia-section av-av_section-8c038a69d7b065b313c8996090138e7a main_color avia-section-default avia-no-border-styling  avia-builder-el-32  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-33  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29svqt-1c23f9f31aac8645fbbb2d1102ae9c0a\">\n#top .av-special-heading.av-mm29svqt-1c23f9f31aac8645fbbb2d1102ae9c0a{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-mm29svqt-1c23f9f31aac8645fbbb2d1102ae9c0a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-mm29svqt-1c23f9f31aac8645fbbb2d1102ae9c0a .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-mm29svqt-1c23f9f31aac8645fbbb2d1102ae9c0a .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-mm29svqt-1c23f9f31aac8645fbbb2d1102ae9c0a av-special-heading-h2  avia-builder-el-34  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Our service approach <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-mm29tcym-ee17c86057e4afc2034d81f56ae5315b \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p><span data-contrast=\"none\"><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> supports you across the entire lifecycle:<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<ul>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Establishing organizational and structural foundations for compliant AI use<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Integrating AI systems into existing IT and <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> landscapes<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Supporting&nbsp;validation&nbsp;and&nbsp;qualification&nbsp;projects<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Developing risk-based control and monitoring concepts<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<li aria-setsize=\"-1\" data-leveltext=\"&#61623;\" data-font=\"Symbol\" data-listid=\"8\" data-list-defn-props='{\"335552541\":1,\"335559685\":720,\"335559991\":360,\"469769226\":\"Symbol\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"&#61623;\",\"469777815\":\"multilevel\"}' data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Supporting supplier evaluation, <a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a> preparation, and compliance evidence<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">In addition, we use AI selectively to increase efficiency 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> within CSV itself.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-36  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-fa708d047516d350251f23d4137c1cf5\">\n.avia-section.av-av_section-fa708d047516d350251f23d4137c1cf5{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bild-KI-3.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_9\" class=\"avia-section av-av_section-fa708d047516d350251f23d4137c1cf5 main_color avia-section-default avia-no-border-styling  avia-builder-el-37  el_after_av_section  el_before_av_section  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13176\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-38  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-39  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf\">\n#top .av-special-heading.av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-mm29tw4h-4d1e7263ea8e1adf3095d67a7724c9cf av-special-heading-h2 custom-color-heading  avia-builder-el-40  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">QFINITY &mdash; your partner for AI in regulated environments <\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mm29v058-4262e3f03dc2bc564f10c8a06d6cd31c\">\n#top .av_textblock_section.av-mm29v058-4262e3f03dc2bc564f10c8a06d6cd31c .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section class=\"av_textblock_section av-mm29v058-4262e3f03dc2bc564f10c8a06d6cd31c \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><p><span data-contrast=\"none\">AI in the&nbsp;GxP&nbsp;environment requires more than technological <a href=\"https:\/\/q-finity.de\/en\/glossar\/integration\/\" target=\"_self\" title=\"Integration describes the building of hardware and\/or implementation of software components to create a complete system. Integration tests check the function and interaction of the individual components. For more information about integration contact us here.\" class=\"encyclopedia\">integration<\/a>.<\/span><br>\n<span data-contrast=\"none\">It demands structural change and a new understanding of responsibility.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">Our goal is to consistently combine regulatory assurance and innovation.<\/span><br>\n<span data-contrast=\"none\">So that AI systems&nbsp;remain&nbsp;robust, <a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a>-ready, and operationally stable over the long term&mdash;and the expected added value can&nbsp;actually be&nbsp;achieved beyond pilot applications.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">T<\/span><span data-contrast=\"none\">he structural framing should be&nbsp;established&nbsp;before regulatory inconsistencies or operational roadblocks arise<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">Let&rsquo;s&nbsp;assess together how your AI initiative can be implemented in a way that is both&nbsp;regulatorily sound&nbsp;and effective in practice.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-contrast=\"none\">&#128073;<\/span><span data-contrast=\"none\">&nbsp;Talk&nbsp;to&nbsp;us.<\/span><span data-ccp-props='{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":1,\"335551620\":1,\"335559739\":120,\"335559740\":240}'>&nbsp;<\/span><\/p>\n<p><span data-ccp-props='{\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559739\":120,\"335559740\":360}'>&nbsp;<\/span><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lydagycl-e46dad9cdcf787262c845f668890639a\">\n.avia-section.av-lydagycl-e46dad9cdcf787262c845f668890639a{\nbackground-color:#ffffff;\nbackground-image:unset;\n}\n.avia-section.av-lydagycl-e46dad9cdcf787262c845f668890639a 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av_one_half  avia-builder-el-45  el_after_av_one_half  el_before_av_one_half  flex_column_div  \"><\/div><div class=\"flex_column_table av-av_one_half-f6e6835ccd39617df8dd44e269c7a0ed sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-f6e6835ccd39617df8dd44e269c7a0ed\">\n.flex_column.av-av_one_half-f6e6835ccd39617df8dd44e269c7a0ed{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-f6e6835ccd39617df8dd44e269c7a0ed av_one_half  avia-builder-el-46  el_after_av_one_half  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-middle  column-top-margin\"><form action=\"https:\/\/q-finity.de\/en\/artificial-intelligence\/\" method=\"post\" data-fields-with-error=\"Found errors in the following field(s):\" class=\"avia_ajax_form av-form-labels-hidden   avia-builder-el-47  avia-builder-el-no-sibling   \" data-avia-form-id=\"1\" data-avia-redirect=\"\"><fieldset><p class=\"  first_form  form_element form_element_half\" id=\"element_avia_1_1\"><label for=\"avia_1_1\">Name <abbr class=\"required\" title=\"required\">*<\/abbr><\/label> <input name=\"avia_1_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_1_1\" value=\"\" placeholder=\"Name*\"><\/p><p class=\"  form_element form_element_half\" id=\"element_avia_2_1\"><label for=\"avia_2_1\">E-Mail <abbr class=\"required\" title=\"required\">*<\/abbr><\/label> <input name=\"avia_2_1\" class=\"text_input is_email\" type=\"text\" id=\"avia_2_1\" value=\"\" placeholder=\"E-Mail*\"><\/p><p class=\"  first_form  form_element form_element_half\" id=\"element_avia_3_1\"><label for=\"avia_3_1\">Telefon<\/label> <input name=\"avia_3_1\" class=\"text_input \" type=\"text\" id=\"avia_3_1\" value=\"\" placeholder=\"Telefon\"><\/p><p class=\"  form_element form_element_half\" id=\"element_avia_4_1\"><label for=\"avia_4_1\">Unternehmen<\/label> <input name=\"avia_4_1\" class=\"text_input \" type=\"text\" id=\"avia_4_1\" value=\"\" placeholder=\"Unternehmen\"><\/p><p class=\"  first_form  form_element form_fullwidth\" id=\"element_avia_5_1\"><label for=\"avia_5_1\">Thema<\/label><select name=\"avia_5_1\" class=\"select \" id=\"avia_5_1\"><option class=\"av-placeholder\" disabled selected value=\"\">Thema<\/option><option value=\"Strategien zur digitalen Transformation\">Strategien zur digitalen Transformation<\/option><option value=\"Gesch&auml;ftsprozessmanagement\">Gesch&auml;ftsprozessmanagement<\/option><option value=\"Qualit&auml;ts-, Risiko-,(GxP-)Compliancemanagement und kontinuierliche Verbesserung\">Qualit&auml;ts-, Risiko-,(GxP-)Compliancemanagement und kontinuierliche Verbesserung<\/option><option value=\"Prozess-Compliance und Qualit&auml;tssicherung f&uuml;r klinische Pr&uuml;fungen\">Prozess-Compliance und Qualit&auml;tssicherung f&uuml;r klinische Pr&uuml;fungen<\/option><option value=\"Konzepte und Umsetzung von Data Governance \/ Datenqualit&auml;t \/ Datenintegrit&auml;t\">Konzepte und Umsetzung von Data Governance \/ Datenqualit&auml;t \/ Datenintegrit&auml;t<\/option><option value=\"Konzepte zum Umgang mit elektrischen Aufzeichnungen und Unterschriften (ERES)\">Konzepte zum Umgang mit elektrischen Aufzeichnungen und Unterschriften (ERES)<\/option><option value=\"Prozessvalidierung und Qualifizierung von Equipment, Anlagen oder Systemen\">Prozessvalidierung und Qualifizierung von Equipment, Anlagen oder Systemen<\/option><option value=\"Validierung und Betrieb von ERP Systemen\">Validierung und Betrieb von ERP Systemen<\/option><option value=\"Validierung von computergest&uuml;tzten Systemen (CSV) - klinische Systeme, Laborsysteme, Produktionssysteme, IT Systeme, Medizintechnik, Lieferanten etc.\">Validierung von computergest&uuml;tzten Systemen (CSV) - klinische Systeme, Laborsysteme, Produktionssysteme, IT Systeme, Medizintechnik, Lieferanten etc.<\/option><option value=\"IT Infrastruktur - Qualifizierung und Compliance\">IT Infrastruktur - Qualifizierung und Compliance<\/option><\/select><\/p><p class=\"  first_form  form_element form_fullwidth\" id=\"element_avia_6_1\"><label for=\"avia_6_1\">Betreff<\/label> <input name=\"avia_6_1\" class=\"text_input \" type=\"text\" id=\"avia_6_1\" value=\"\" placeholder=\"Betreff\"><\/p><p class=\"  first_form  form_element form_fullwidth\" id=\"element_avia_7_1\"><label for=\"avia_7_1\" class=\"textare_label hidden textare_label_avia_7_1\">Nachricht <abbr class=\"required\" title=\"required\">*<\/abbr><\/label><textarea placeholder=\"Nachricht*\" name=\"avia_7_1\" class=\"text_area is_empty\" cols=\"40\" rows=\"7\" id=\"avia_7_1\"><\/textarea><\/p><div id=\"avia_8_1\" class=\"av-form-text\"><p>\n* Pflichtfelder<\/p>\n<\/div><p class=\"hidden\"><input type=\"text\" name=\"avia_9_1\" class=\"hidden \" id=\"avia_9_1\" value=\"\"><\/p><p class=\"form_element \"><input type=\"hidden\" value=\"1\" name=\"avia_generated_form1\"><input type=\"submit\" value=\"Senden\" class=\"button\" data-sending-label=\"Sending\"><\/p><\/fieldset><\/form><div id=\"ajaxresponse_1\" class=\"ajaxresponse ajaxresponse_1 hidden\"><\/div><\/div><div class=\"av-flex-placeholder\"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-48  el_after_av_one_half  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-middle  column-top-margin\"><\/div><\/div><!--close column table wrapper. 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class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-49f6e875884219cf77c24341e550af53\">\n.flex_column.av-av_one_half-49f6e875884219cf77c24341e550af53{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-49f6e875884219cf77c24341e550af53 av_one_half  avia-builder-el-53  el_after_av_one_half  el_before_av_one_full  flex_column_div av-zero-column-padding  \"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_full-79ff81c021393065cee878051452f6a6\">\n.flex_column.av-av_one_full-79ff81c021393065cee878051452f6a6{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_full-79ff81c021393065cee878051452f6a6 av_one_full  avia-builder-el-54  el_after_av_one_half  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><div id=\"av-masonry-1\" class=\"av-masonry av-av_masonry_entries-29157dd713ef718f539eff79bdefee47 noHover av-fixed-size av-large-gap av-hover-overlay-active av-masonry-animation-active av-masonry-col-4 av-caption-always av-caption-style-overlay av-masonry-entries \" data-post_id=\"13176\"><div class=\"av-masonry-container isotope av-js-disabled\"><div class=\"av-masonry-entry isotope-item av-masonry-item-no-image \"><\/div><a href=\"https:\/\/q-finity.de\/en\/ispe-ai-in-life-sciences-summit-with-qfinity-22-23-june-2026-2\/\" id=\"av-masonry-1-item-14517\" data-av-masonry-item=\"14517\" class=\"av-masonry-entry isotope-item post-14517 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">QFINITY will be represented at the ISPE AI in Life Sciences Summit&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">4. May 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/live-online-training-gxp-systems-digital-compliance-fundamentals-with-qfinity-08-may-2026\/\" id=\"av-masonry-1-item-14514\" data-av-masonry-item=\"14514\" class=\"av-masonry-entry isotope-item post-14514 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"Live online training &ldquo;GxP Systems &amp; Digital Compliance Fundamentals&rdquo; with QFINITY | 08. May 2026\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">Live online training &ldquo;GxP Systems &amp; Digital Compliance Fundamentals&rdquo; with QFINITY | 08. May 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">On 8 May 2026, the live online training &ldquo;GxP Systems &amp;&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">4. May 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/cloud-services\/\" id=\"av-masonry-1-item-14507\" data-av-masonry-item=\"14507\" class=\"av-masonry-entry isotope-item post-14507 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"Enabling GxP-Compliant Cloud Services through Global QMS Enhancement\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">Enabling GxP-Compliant Cloud Services through Global QMS Enhancement<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">In this case study, an existing quality management system was&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">26. April 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/it-quality-management\/\" id=\"av-masonry-1-item-14481\" data-av-masonry-item=\"14481\" class=\"av-masonry-entry isotope-item post-14481 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">In this case study, the focus is on the restoration of IT systems&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">8. April 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-37da22849bbdc4631593481053ea0ad2\">\n.flex_column.av-av_one_half-37da22849bbdc4631593481053ea0ad2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\nbackground-color:#ea5a0c;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-37da22849bbdc4631593481053ea0ad2 av_one_half  avia-builder-el-56  el_after_av_one_full  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><div class=\"avia-buttonrow-wrap av-av_buttonrow-55299ef8269dc67e8269173e1abda200 avia-buttonrow-left  avia-builder-el-57  avia-builder-el-no-sibling \">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_buttonrow_item-dccaec55814c02fff16c8cc6908b75a0\">\n#top #wrap_all .avia-button.av-av_buttonrow_item-dccaec55814c02fff16c8cc6908b75a0{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-av_buttonrow_item-dccaec55814c02fff16c8cc6908b75a0:hover{\nbackground-color:white;\ncolor:black;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-av_buttonrow_item-dccaec55814c02fff16c8cc6908b75a0:hover .avia-svg-icon svg:first-child{\nfill:black;\nstroke:black;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-av_buttonrow_item-dccaec55814c02fff16c8cc6908b75a0 avia-icon_select-yes-right-icon avia-size-x-large av-icon-on-hover avia-color-white avia-font-color-black\" aria-label=\"Zu unseren News\"><span class=\"avia_iconbox_title\">Zu unseren News<\/span><span class=\"avia_button_icon avia_button_icon_right avia-iconfont avia-font-entypo-fontello\" data-av_icon=\"&#59517;\" data-av_iconfont=\"entypo-fontello\"><\/span><\/a>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-49f6e875884219cf77c24341e550af53\">\n.flex_column.av-av_one_half-49f6e875884219cf77c24341e550af53{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-49f6e875884219cf77c24341e550af53 av_one_half  avia-builder-el-58  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin\"><\/div>\n\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-13176","page","type-page","status-publish","hentry"],"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>Artificial Intelligence<\/title>\n<meta name=\"description\" content=\"Artificial intelligence is the &quot;next big thing&quot; QFINITY offers help through the validation of AI Solutions. 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