{"id":15113,"date":"2026-06-18T09:05:58","date_gmt":"2026-06-18T07:05:58","guid":{"rendered":"https:\/\/q-finity.de\/news-2-2\/"},"modified":"2026-07-17T12:51:15","modified_gmt":"2026-07-17T10:51:15","slug":"news-2","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/news-2\/","title":{"rendered":"News"},"content":{"rendered":"\n<div class=\"av-alb-blogposts template-blog  av-blog-meta-author-disabled av-blog-meta-comments-disabled av-blog-meta-category-disabled av-blog-meta-date-disabled av-blog-meta-tag-disabled \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Blog\"><article class=\"post-entry post-entry-type-standard post-entry-16099 post-loop-1 post-parity-odd single-big with-slider post-16099 post type-post status-publish format-standard has-post-thumbnail hentry category-meet-qfinity-en\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\"><div class=\"blog-meta\"><\/div><div class=\"entry-content-wrapper clearfix standard-content\"><header class=\"entry-content-header\" aria-label=\"Post: BPD Biopharmaceutical Bioprocess Development Summit with QFINITY | August 6-7, 2026\"><div class=\"av-heading-wrapper\"><span class=\"blog-categories minor-meta\"><a href=\"https:\/\/q-finity.de\/en\/kategorie\/meet-qfinity-en\/\" rel=\"tag\">Meet Qfinity<\/a><\/span><h2 class=\"post-title entry-title \" itemprop=\"headline\"><a href=\"https:\/\/q-finity.de\/en\/bpd-biopharmaceutical-bioprocess-development-summit-with-qfinity-august-6-7-2026\/\" rel=\"bookmark\" title=\"Permanent Link: BPD Biopharmaceutical Bioprocess Development Summit with QFINITY | August 6-7, 2026\">BPD Biopharmaceutical Bioprocess Development Summit with QFINITY | August 6-7, 2026<span class=\"post-format-icon minor-meta\"><\/span><\/a><\/h2><\/div><\/header><span class=\"av-vertical-delimiter\"><\/span><div class=\"big-preview single-big\" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"><a href=\"https:\/\/q-finity.de\/en\/bpd-biopharmaceutical-bioprocess-development-summit-with-qfinity-august-6-7-2026\/\" title=\"BPD Summit 2026 tour timeline\"><img data-opt-id=1020090334  fetchpriority=\"high\" decoding=\"async\" loading=\"lazy\" width=\"1210\" height=\"423\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1210\/h:423\/q:mauto\/rt:fill\/g:ce\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/bpd-summit-2026-hero.png\" class=\"wp-image-16096 avia-img-lazy-loading-16096 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"BPD Biopharmaceutical Bioprocess Development Summit - tour stops and dates across China, Singapore and the USA in 2026\"><\/a><\/div><div class=\"entry-content\" itemprop=\"text\"><p>We are glad to be at the 9th BPD Biopharmaceutical Bioprocess Development Summit in Shanghai!<\/p>\n<p>The summit runs August 6-7, 2026 in Shanghai &ndash; China&rsquo;s benchmark event for biopharmaceutical process development, from research to commercial manufacturing. Since 2017 it has connected the entire CMC value chain; the 2025 edition drew more than 5,500 attendees and over 160 speakers. The AI FOR PHARMA Conference 2026 runs alongside it.<\/p>\n<h2>QFINITY on stage<\/h2>\n<p>Oliver Herrmann (QFINITY) and Martin Heitmann (MH Consulting &amp; Advisory) are pleased to speak at both conferences on August 6: at the BPD Summit itself on the shift in EU GMP regulation, and at the parallel AI FOR PHARMA Conference on how adaptive AI only becomes GMP-ready under control.<\/p>\n<h3>Shifting the EU GMP Regulatory Paradigm &ndash; Annex 11 and Annex 22 Drafts<\/h3>\n<p><strong>Oliver Herrmann<\/strong> (QFINITY) and <strong>Martin Heitmann<\/strong> (MH Consulting &amp; Advisory)<\/p>\n<p>&ldquo;Global Expansion &amp; Globalization&rdquo; track. For companies expanding into European markets, the regulatory ground is shifting: the revised <a href=\"https:\/\/q-finity.de\/en\/glossar\/eu-gmp-annex-11\/\" target=\"_self\" title='EU GMP Annex 11 (\"Computerised Systems\") is the European GMP annex for computerized systems: introduced in 1992, current in its 2011 version, part of EudraLex Vol. 4. Its principle divides the world of evidence in two: the application is validated, the IT infrastructure is qualified. Annex 11 requires a risk-based approach across the entire lifecycle&hellip;' class=\"encyclopedia\">EU GMP Annex 11<\/a> and the new Annex 22 draft reshape how computerized systems &ndash; and, increasingly, AI &ndash; are assessed in GxP environments. The talk maps out what quality, IT, and regulatory teams need to prepare for.<\/p>\n<h3>Adaptive AI Without Control is Not GMP &ndash; From Potential to Controlled Biopharma<\/h3>\n<p><em>Digital Compliance Architecture for Trustworthy Adaptive AI-Enabled Systems from <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"A process is a set of interrelated or interacting activities which transform inputs into outputs.\" class=\"encyclopedia\">Process<\/a> Development to GxP Manufacturing<\/em><\/p>\n<p><strong>Oliver Herrmann<\/strong> (QFINITY) and <strong>Martin Heitmann<\/strong> (MH Consulting &amp; Advisory)<\/p>\n<p>AI FOR PHARMA Conference. Adaptive AI systems change their behavior as new data comes in &ndash; exactly what makes them powerful and hard to keep in check. Without robust control, that potential never reaches GMP. The talk outlines a digital compliance architecture that keeps adaptive, AI-enabled systems trustworthy and verifiable, from process development through to GxP manufacturing.<\/p>\n<p>Meet us in Shanghai &ndash; we look forward to connecting in person.<\/p>\n<\/div><span class=\"post-meta-infos\"><\/span><footer class=\"entry-footer\"><\/footer><div class=\"post_delimiter\"><\/div><\/div><div class=\"post_author_timeline\"><\/div><span class=\"hidden\">\n\t\t\t\t<span class=\"av-structured-data\" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\">\n\t\t\t\t\t\t<span itemprop=\"url\">https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/bpd-summit-2026-hero.png<\/span>\n\t\t\t\t\t\t<span itemprop=\"height\">698<\/span>\n\t\t\t\t\t\t<span itemprop=\"width\">1924<\/span>\n\t\t\t\t<\/span>\n\t\t\t\t<span class=\"av-structured-data\" itemprop=\"publisher\" itemtype=\"https:\/\/schema.org\/Organization\" itemscope=\"itemscope\">\n\t\t\t\t\t\t<span itemprop=\"name\">oherrmann<\/span>\n\t\t\t\t\t\t<span itemprop=\"logo\" itemscope itemtype=\"https:\/\/schema.org\/ImageObject\">\n\t\t\t\t\t\t\t<span itemprop=\"url\">https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/q-finity_schriftzug_orange-retina.png<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t\t\t<\/span><span class=\"av-structured-data\" itemprop=\"author\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Person\"><span itemprop=\"name\">oherrmann<\/span><\/span><span class=\"av-structured-data\" itemprop=\"datePublished\" datetime=\"2026-07-07T08:36:50+02:00\">2026-07-07 08:36:50<\/span><span class=\"av-structured-data\" itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\">2026-07-15 14:12:21<\/span><span class=\"av-structured-data\" itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\"><span itemprop=\"name\">BPD Biopharmaceutical Bioprocess Development Summit with QFINITY | August 6-7, 2026<\/span><\/span><\/span><\/article><article class=\"post-entry post-entry-type-standard post-entry-16539 post-loop-2 post-parity-even single-big with-slider post-16539 post type-post status-publish format-standard has-post-thumbnail hentry category-news-category\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\"><div class=\"blog-meta\"><\/div><div class=\"entry-content-wrapper clearfix standard-content\"><header class=\"entry-content-header\" aria-label=\"Post: QFINITY at the ISPE AI Summit 2026: Advancing Practical AI Applications in GxP\"><div class=\"av-heading-wrapper\"><span class=\"blog-categories minor-meta\"><a href=\"https:\/\/q-finity.de\/en\/kategorie\/news-category\/\" rel=\"tag\">News<\/a><\/span><h2 class=\"post-title entry-title \" itemprop=\"headline\"><a href=\"https:\/\/q-finity.de\/en\/qfinity-at-ispe-ai-summit-2026\/\" rel=\"bookmark\" title=\"Permanent Link: QFINITY at the ISPE AI Summit 2026: Advancing Practical AI Applications in GxP\">QFINITY at the ISPE AI Summit 2026: Advancing Practical AI Applications in GxP<span class=\"post-format-icon minor-meta\"><\/span><\/a><\/h2><\/div><\/header><span class=\"av-vertical-delimiter\"><\/span><div class=\"big-preview single-big\" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"><a href=\"https:\/\/q-finity.de\/en\/qfinity-at-ispe-ai-summit-2026\/\" title=\"boston-team-gruppe\"><img data-opt-id=1973687154  fetchpriority=\"high\" decoding=\"async\" loading=\"lazy\" width=\"1210\" height=\"423\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1210\/h:423\/q:mauto\/rt:fill\/g:ce\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/boston-team-gruppe.jpg\" class=\"wp-image-16546 avia-img-lazy-loading-16546 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"QFINITY-Team beim ISPE AI in Life Sciences Summit 2026 in Boston\"><\/a><\/div><div class=\"entry-content\" itemprop=\"text\"><p class=\"qf-abstract\">The first ISPE AI in Life Sciences Summit &ndash; Powered by GAMP put one question at its centre, a question QFINITY has worked on for years: how do you move AI in GxP environments from experiment to validated, responsible use? QFINITY was on site and helped shape the content &ndash; among other things with a workshop on working with AI suppliers.<\/p>\n<figure class=\"qf-figure right\"><img data-opt-id=1299451925  fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/boston-skyline-charles-river.jpg\" alt=\"Boston skyline on the Charles River\"><figcaption><b>Setting<\/b>Boston on the Charles River &ndash; host city of the first Summit.<\/figcaption><\/figure>\n<p>The Summit turned on a core question for regulated life sciences: what changes when AI enters the picture &ndash; and what does not? Collaboration between the regulated user and the supplier was always demanding: different vocabularies, quality brought in too late, short-notice changes in SaaS services. AI sharpens these familiar challenges and adds new ones &ndash; dynamic models, model drift, a higher relevance of data, ongoing performance monitoring.<\/p>\n<p>The answer, however, is not a new discipline: it is the proven <a href=\"https:\/\/q-finity.de\/en\/glossar\/gamp-5-begriff\/\" target=\"_self\" title=\"GAMP 5 - &quot;A Risk-Based Approach to Compliant GxP Computerized Systems&quot; - is ISPE's industry guide to the validation of computerized systems: published in 2008, and available since 2022 in the Second Edition, which strengthens critical thinking and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements - GAMP shows a&hellip;\" class=\"encyclopedia\">GAMP 5<\/a> key principles, critical thinking and a risk-based approach &ndash; the right mix of flexibility and rigor.<\/p>\n<div style=\"clear:both\"><\/div>\n<h2>Four blind spots in AI supplier relationships<\/h2>\n<p>How concrete this gets became clear in the workshop, drawing on real gaps that recur in AI supplier relationships:<\/p>\n<div class=\"qf-gaplist\">\n<div class=\"qf-gap\">\n<div class=\"qf-gap-n\">1<\/div>\n<div class=\"qf-gap-t\"><b>The AI supplier updates the model without notice.<\/b> In a GxP environment this is an unauthorized change to the validated state &ndash; the regulated user loses their evidence without knowing it.<\/div>\n<\/div>\n<div class=\"qf-gap\">\n<div class=\"qf-gap-n\">2<\/div>\n<div class=\"qf-gap-t\"><b>The LLM provider was never qualified as a sub-supplier.<\/b> The audit scope extends to the sub-supplier; a SOC 2 attestation does not cover the GxP-specific obligations.<\/div>\n<\/div>\n<div class=\"qf-gap\">\n<div class=\"qf-gap-n\">3<\/div>\n<div class=\"qf-gap-t\"><b>The contract contains no audit rights.<\/b> For GxP-critical AI, certificates are necessary but not sufficient &ndash; without a contractual right, the supplier can decline any audit.<\/div>\n<\/div>\n<div class=\"qf-gap\">\n<div class=\"qf-gap-n\">4<\/div>\n<div class=\"qf-gap-t\"><b>The provider trains on your data.<\/b> Sensitive deviation descriptions flow to a third party &ndash; without an explicit contractual arrangement, no GxP company can accept this.<\/div>\n<\/div>\n<\/div>\n<p class=\"qf-keyq\">The decisive question behind every gap: what would you put in front of an inspector to justify your validation strategy?<\/p>\n<figure class=\"qf-figure left\"><img data-opt-id=1174086102  fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/mit-campus-pasteur-fries-rotated.jpg\" alt=\"Frieze at MIT with the names Pasteur, Linnaeus, Jenner\"><figcaption><b>The depth<\/b>Between sessions: the MIT campus, where the names of scientific history are carved in stone &ndash; Pasteur, Linnaeus, Jenner.<\/figcaption><\/figure>\n<p>The regulatory framework for this is taking shape right now: the draft <a href=\"https:\/\/q-finity.de\/en\/glossar\/eu-gmp-annex-22\/\" target=\"_self\" title=\"EU GMP Annex 22 (&ldquo;Artificial Intelligence&rdquo;) is the planned AI annex to the EU GMP guideline: it adds the evidence for embedded AI models to Annex 11 - in the draft limited, for critical applications, to static models with deterministic output.\" class=\"encyclopedia\">EU GMP Annex 22<\/a> requires the regulated user to review the documentation &ndash; regardless of whether the model is trained in-house or by a supplier. Methodological orientation comes from the ISPE GAMP Guide: Artificial Intelligence (2025), and the EU AI Act draws a further line with its distinction between provider and deployer. Specific guidance on AI supplier management is still rare &ndash; and this is where QFINITY works at the leading edge.<\/p>\n<p>That QFINITY helps shape this development is no coincidence: as chair of the GAMP Global Steering Committee, Frank Henrichmann, Senior Executive Consultant at QFINITY, is close to where these guidelines take form. The real value, however, is created where QFINITY translates this still-young framework into robust practice &ndash; from AI experiment to validated, audit-ready use.<\/p>\n<div style=\"clear:both\"><\/div>\n<div class=\"qf-carousel\" data-qf-carousel tabindex=\"0\" aria-roledescription=\"Karussell\" aria-label=\"From the Summit and around Boston\">\n<div class=\"qf-car-head\"><span class=\"qf-car-eyebrow\">Impressions<\/span><span class=\"qf-car-title\">From the Summit and around Boston<\/span><span class=\"qf-car-count\"><b class=\"cur\">1<\/b>&thinsp;\/&thinsp;4<\/span><\/div>\n<div class=\"qf-car-viewport\">\n<div class=\"qf-car-track\">\n<figure class=\"qf-car-slide\"><img data-opt-id=198991585  fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/qfinity-fachaustausch-summit.jpg\" alt=\"QFINITY in professional exchange at the ISPE AI Summit 2026\"><figcaption>Professional exchange on the sidelines of the sessions.<\/figcaption><\/figure>\n<figure class=\"qf-car-slide\"><img data-opt-id=1024904868  fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/ispe-ai-summit-2026-welcome-rotated.jpg\" alt=\"Welcome stele of the ISPE AI Summit 2026\"><figcaption>Welcome: 2026 ISPE AI in Life Sciences Summit &ndash; Powered by GAMP.<\/figcaption><\/figure>\n<figure class=\"qf-car-slide\"><img data-opt-id=224947555  data-opt-src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/mit-campus-bronze-skulptur-rotated.jpg\"  decoding=\"async\" src=\"data:image/svg+xml,%3Csvg%20viewBox%3D%220%200%20100%%20100%%22%20width%3D%22100%%22%20height%3D%22100%%22%20xmlns%3D%22http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%22%3E%3Crect%20width%3D%22100%%22%20height%3D%22100%%22%20fill%3D%22transparent%22%2F%3E%3C%2Fsvg%3E\" alt=\"Bronze sculpture on the MIT campus\"><figcaption>Art and science on the MIT campus.<\/figcaption><\/figure>\n<figure class=\"qf-car-slide\"><img data-opt-id=1099693098  data-opt-src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/mit-campus-granit-skulptur.jpg\"  decoding=\"async\" src=\"data:image/svg+xml,%3Csvg%20viewBox%3D%220%200%20100%%20100%%22%20width%3D%22100%%22%20height%3D%22100%%22%20xmlns%3D%22http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%22%3E%3Crect%20width%3D%22100%%22%20height%3D%22100%%22%20fill%3D%22transparent%22%2F%3E%3C%2Fsvg%3E\" alt=\"Granite sculpture on the MIT campus\"><figcaption>Modern forms on the MIT campus.<\/figcaption><\/figure>\n<\/div>\n<p><button class=\"qf-car-btn qf-car-prev\" aria-label=\"prev\">&lsaquo;<\/button><button class=\"qf-car-btn qf-car-next\" aria-label=\"next\">&rsaquo;<\/button><\/p><\/div>\n<div class=\"qf-car-dots\"><button class=\"qf-car-dot on\" aria-label=\"1\"><\/button><button class=\"qf-car-dot\" aria-label=\"2\"><\/button><button class=\"qf-car-dot\" aria-label=\"3\"><\/button><button class=\"qf-car-dot\" aria-label=\"4\"><\/button><\/div>\n<\/div>\n<\/div><span class=\"post-meta-infos\"><\/span><footer class=\"entry-footer\"><\/footer><div class=\"post_delimiter\"><\/div><\/div><div class=\"post_author_timeline\"><\/div><span class=\"hidden\">\n\t\t\t\t<span class=\"av-structured-data\" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\">\n\t\t\t\t\t\t<span itemprop=\"url\">https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/boston-team-gruppe.jpg<\/span>\n\t\t\t\t\t\t<span itemprop=\"height\">1220<\/span>\n\t\t\t\t\t\t<span itemprop=\"width\">1800<\/span>\n\t\t\t\t<\/span>\n\t\t\t\t<span class=\"av-structured-data\" itemprop=\"publisher\" itemtype=\"https:\/\/schema.org\/Organization\" itemscope=\"itemscope\">\n\t\t\t\t\t\t<span itemprop=\"name\">oherrmann<\/span>\n\t\t\t\t\t\t<span itemprop=\"logo\" itemscope itemtype=\"https:\/\/schema.org\/ImageObject\">\n\t\t\t\t\t\t\t<span itemprop=\"url\">https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/q-finity_schriftzug_orange-retina.png<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t\t\t<\/span><span class=\"av-structured-data\" itemprop=\"author\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Person\"><span itemprop=\"name\">oherrmann<\/span><\/span><span class=\"av-structured-data\" itemprop=\"datePublished\" datetime=\"2026-07-06T10:00:00+02:00\">2026-07-06 10:00:00<\/span><span class=\"av-structured-data\" itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\">2026-07-14 20:14:56<\/span><span class=\"av-structured-data\" itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\"><span itemprop=\"name\">QFINITY at the ISPE AI Summit 2026: Advancing Practical AI Applications in GxP<\/span><\/span><\/span><\/article><article class=\"post-entry post-entry-type-standard post-entry-15795 post-loop-3 post-parity-odd post-entry-last single-big with-slider post-15795 post type-post status-publish format-standard has-post-thumbnail hentry category-meet-qfinity-en\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\"><div class=\"blog-meta\"><\/div><div class=\"entry-content-wrapper clearfix standard-content\"><header class=\"entry-content-header\" aria-label=\"Post: ISPE Pharma 4.0 &amp; Biopharma Conference with QFINITY | December 10-11, 2026\"><div class=\"av-heading-wrapper\"><span class=\"blog-categories minor-meta\"><a href=\"https:\/\/q-finity.de\/en\/kategorie\/meet-qfinity-en\/\" rel=\"tag\">Meet Qfinity<\/a><\/span><h2 class=\"post-title entry-title \" itemprop=\"headline\"><a href=\"https:\/\/q-finity.de\/en\/ispe-pharma-4-0-biopharma-conference-with-qfinity-december-10-11-2026\/\" rel=\"bookmark\" title=\"Permanent Link: ISPE Pharma 4.0 &amp; Biopharma Conference with QFINITY | December 10-11, 2026\">ISPE Pharma 4.0 &amp; Biopharma Conference with QFINITY | December 10-11, 2026<span class=\"post-format-icon minor-meta\"><\/span><\/a><\/h2><\/div><\/header><span class=\"av-vertical-delimiter\"><\/span><div class=\"big-preview single-big\" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"><a href=\"https:\/\/q-finity.de\/en\/ispe-pharma-4-0-biopharma-conference-with-qfinity-december-10-11-2026\/\" title=\"pharma-4-0-conference-hero\"><img data-opt-id=412739080  decoding=\"async\" loading=\"lazy\" width=\"1210\" height=\"400\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1210\/h:400\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/pharma-4-0-conference-hero.webp\" class=\"wp-image-15792 avia-img-lazy-loading-15792 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"ISPE Pharma 4.0 &amp; Biopharma Conference 2026 Berlin\"><\/a><\/div><div class=\"entry-content\" itemprop=\"text\"><p>We are pleased to be part of the 2026 ISPE Pharma 4.0 &amp; Biopharma Conference!<\/p>\n<p>The conference takes place on 10-11 December 2026 in Berlin &ndash; a central European meeting point for the digital transformation of the pharmaceutical industry. You can also attend virtually.<\/p>\n<h2>QFINITY on stage<\/h2>\n<p>In his talk, Oliver Herrmann shows how AI reshapes <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word \"qualitas\", which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent characteristics of an object meets requirements. Inherent means \"intrinsic to a particular unit\".' class=\"encyclopedia\">Quality<\/a> Assurance in regulated environments &ndash; and why human oversight must be a designed structural element, not an end-of-line check.<\/p>\n<h3>Human Oversight by Design: Progressive QA for AI-Enabled GxP Systems<\/h3>\n<p><strong>Oliver Herrmann<\/strong> (QFINITY)<\/p>\n<p>AI does not just add tools to GxP. It changes how computerized systems behave. Execution moves from operation to supervision. Deterministic logic gives way to probabilistic output. This does not lower the demand for <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word \"qualitas\", which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent characteristics of an object meets requirements. Inherent means \"intrinsic to a particular unit\".' class=\"encyclopedia\">Quality<\/a> Assurance. It raises it.<\/p>\n<p>Quality no longer comes from validating a system in isolation. It emerges from the interaction of business processes, data, software, interfaces and decision structures. QA stops being a downstream control and becomes the architect of the landscape it once only inspected.<\/p>\n<p>The GAMP AI Guide draws the distinction that carries this shift: the AI subsystem is not the computerized system, and the model is a component. What you validate is the system, against its intended use &ndash; not the model in the abstract. Human oversight is where this becomes concrete. Treated as a check at the end of the line, it controls nothing; designed into the architecture, it holds. Oversight is not a stage you add once the system runs &ndash; it is a property you build before it does.<\/p>\n<p>AI runs on statistical inference. It produces plausibility, not understanding. Between a plausible output and a correct decision sits a structural gap. It does not close by trusting the model &ndash; it closes by design. Progressive QA is the answer to rising speed and complexity, managing the process, data and system layers at once. The core message: capability is not reliability &ndash; and the work of QA is to make that difference visible before the system does.<\/p>\n<p><a class=\"qf-extref\" href=\"https:\/\/ispe.org\/conferences\/2026-pharma-40-biopharma-conference\" target=\"_blank\" rel=\"noopener\"><span class=\"qf-extref-text\">Program and registration at ISPE (ispe.org)<\/span><span class=\"qf-extref-arrow\">&#8599;<\/span><\/a><\/p>\n<p>Attending in person? Reach out &ndash; we look forward to connecting.<\/p>\n<\/div><span class=\"post-meta-infos\"><\/span><footer class=\"entry-footer\"><\/footer><div class=\"post_delimiter\"><\/div><\/div><div class=\"post_author_timeline\"><\/div><span class=\"hidden\">\n\t\t\t\t<span class=\"av-structured-data\" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\">\n\t\t\t\t\t\t<span itemprop=\"url\">https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/pharma-4-0-conference-hero.webp<\/span>\n\t\t\t\t\t\t<span itemprop=\"height\">400<\/span>\n\t\t\t\t\t\t<span itemprop=\"width\">1900<\/span>\n\t\t\t\t<\/span>\n\t\t\t\t<span class=\"av-structured-data\" itemprop=\"publisher\" itemtype=\"https:\/\/schema.org\/Organization\" itemscope=\"itemscope\">\n\t\t\t\t\t\t<span itemprop=\"name\">oherrmann<\/span>\n\t\t\t\t\t\t<span itemprop=\"logo\" itemscope itemtype=\"https:\/\/schema.org\/ImageObject\">\n\t\t\t\t\t\t\t<span itemprop=\"url\">https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/q-finity_schriftzug_orange-retina.png<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t\t\t<\/span><span class=\"av-structured-data\" itemprop=\"author\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Person\"><span itemprop=\"name\">oherrmann<\/span><\/span><span class=\"av-structured-data\" itemprop=\"datePublished\" datetime=\"2026-07-01T20:44:53+02:00\">2026-07-01 20:44:53<\/span><span class=\"av-structured-data\" itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\">2026-07-15 14:25:22<\/span><span class=\"av-structured-data\" itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\"><span itemprop=\"name\">ISPE Pharma 4.0 &amp; Biopharma Conference with QFINITY | December 10-11, 2026<\/span><\/span><\/span><\/article><div class=\"single-big\"><nav class=\"pagination\"><span class=\"pagination-meta\">Page 1 of 44<\/span><span class=\"current\">1<\/span><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/15113\/page\/2\/\" class=\"inactive next_page\">2<\/a><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/15113\/page\/3\/\" class=\"inactive\">3<\/a><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/15113\/page\/2\/\">&rsaquo;<\/a><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/15113\/page\/44\/\">&raquo;<\/a><\/nav>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"We are pleased to be part of the 2026 ISPE Pharma 4.0 &amp; Biopharma Conference!\nThe conference takes place on 10-11 December 2026 in Berlin &#8211; a central European meeting point for the digital transformation of the pharmaceutical industry. You&hellip;","protected":false},"author":5,"featured_media":15422,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-15113","page","type-page","status-publish","has-post-thumbnail","hentry"],"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>News: GxP, AI &amp; Quality | QFINITY<\/title>\n<meta name=\"description\" content=\"GxP news from QFINITY: well-founded insights on pharma, quality management, GAMP and AI - what moves regulated quality of tomorrow.\" \/>\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\/news-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"News: GxP, AI &amp; 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