{"id":4961,"date":"2021-02-25T14:24:39","date_gmt":"2021-02-25T13:24:39","guid":{"rendered":"https:\/\/q-finity.de\/news\/meet-qfinity\/"},"modified":"2026-10-19T00:11:36","modified_gmt":"2026-10-18T22:11:36","slug":"meet-qfinity","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/meet-qfinity\/","title":{"rendered":"Meet QFINITY"},"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-17239 post-loop-1 post-parity-odd single-big with-slider post-17239 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: Pharma Smart Manufacturing 2026 in Copenhagen: QFINITY workshop on Data Integrity and ALCOA++ in digital manufacturing systems\"><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\/pharma-smart-manufacturing-2026-copenhagen\/\" rel=\"bookmark\" title=\"Permanent Link: Pharma Smart Manufacturing 2026 in Copenhagen: QFINITY workshop on Data Integrity and ALCOA++ in digital manufacturing systems\">Pharma Smart Manufacturing 2026 in Copenhagen: QFINITY workshop on Data Integrity and ALCOA++ in digital manufacturing systems<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\/pharma-smart-manufacturing-2026-copenhagen\/\" title=\"pharma-smart-manufacturing-2026-copenhagen\"><img data-opt-id=66419328  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\/10\/pharma-smart-manufacturing-2026-copenhagen.jpg\" class=\"wp-image-17240 avia-img-lazy-loading-17240 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"Pharma Smart Manufacturing 2026 Kopenhagen - Fleming-Konferenz - QFINITY-Workshop Data Integrity und ALCOA++\"><\/a><\/div><div class=\"entry-content\" itemprop=\"text\"><p>On October 13 and 14, 2026, Fleming hosts the <strong>Pharma Smart Manufacturing 2026<\/strong> conference at the Scandic Spectrum in Copenhagen under the banner &ldquo;From Roadmaps to Real Impact&rdquo;. Two days focus on how pharmaceutical manufacturers move automation, data platforms and AI from pilot status into validated GMP operations. The program features speakers from Sanofi, Merck KGaA, Novo Nordisk, Roche and Lonza, plus two interactive workshops.<\/p>\n<p>One of the two workshops is led by <strong>Oliver Herrmann<\/strong>, GxP Compliance &amp; AI Consultant, Auditor, Chair of the GAMP Europe Steering Committee and CEO of QFINITY. The workshop is titled <strong>&ldquo;<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.\" class=\"encyclopedia\">Data Integrity<\/a> &amp; <a href=\"https:\/\/q-finity.de\/en\/glossar\/alcoa\/\" target=\"_self\" title=\"ALCOA is a common acronym summarizing the criteria of data integrity (the ALCOA principles). It stands for: Attributable (i.e., identification of the source, the data originator - person, device, or system) Legible (and understandable) Contemporaneous (i.e., recorded at the time) Original (the initial record itself - paper-based or electronic - or a certified\/true copy) Accurate&hellip;\" class=\"encyclopedia\">ALCOA<\/a>++ in Digital Manufacturing Systems: Preparing <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.\" class=\"encyclopedia\">Data<\/a>, Systems and People for AI&rdquo;<\/strong>. At its center is the question of what needs to change in data integrity controls when manufacturing data move between systems and AI starts contributing to quality decisions.<\/p>\n<p>The workshop is interactive: after a short introduction, participants work through a manufacturing case at their tables, and the results are brought together at the end. The frame is set by the current Chapter 4 and Annex 11 requirements, the proposed revisions of both texts and the draft Annex 22 on AI. The workshop runs 90 minutes and is scheduled for the second conference day, October 14, at 11:00 am.<\/p>\n<p><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.\" class=\"encyclopedia\">Data<\/a> integrity and the regulation of AI are part of our daily work. How data integrity is secured in regulated operations is the subject of our service area <a href=\"https:\/\/q-finity.de\/en\/service-areas\/data-integrity-in-gxp-regulated-fields\/\">Data Integrity in GxP-regulated Fields<\/a>. The regulatory frame is explained on our pages on the <a href=\"https:\/\/q-finity.de\/en\/eu-gmp-annex-11-revision\/\">Annex 11 revision<\/a> and the <a href=\"https:\/\/q-finity.de\/en\/eu-gmp-annex-22\/\">draft EU GMP Annex 22<\/a>.<\/p>\n<p><a class=\"qf-extref\" href=\"https:\/\/fleming.events\/pharma-smart-manufacturing\/\" target=\"_blank\" rel=\"noopener\"><span class=\"qf-extref-text\">Program, brochure and tickets at Fleming (fleming.events)<\/span><span class=\"qf-extref-arrow\">&#8599;<\/span><\/a><\/p>\n<p>Joining us in Copenhagen? Oliver looks forward to the exchange at the table and on the sidelines of the conference. Or <a href=\"https:\/\/q-finity.de\/en\/contact\/#formular\">book a call directly<\/a>.<\/p>\n<aside class=\"qf-update\">\n<p class=\"qf-update-meta\"><time datetime=\"2026-10-18\">October 18, 2026<\/time><\/p>\n<p>The format from Copenhagen is now available as a one-day workshop at your site: <a href=\"https:\/\/q-finity.de\/en\/ai-gmp-workshop\/\">AI GMP Workshop: Who Decides, Who Stops?<\/a> Around 80 participants worked on four cases at five tables in Copenhagen; the three findings that recurred at almost every table are documented on the workshop page. The organizer included the sentence &ldquo;<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> is not a system property. It is an architectural one.&rdquo; in the conference synthesis.<\/p>\n<\/aside>\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\/10\/pharma-smart-manufacturing-2026-copenhagen.jpg<\/span>\n\t\t\t\t\t\t<span itemprop=\"height\">1440<\/span>\n\t\t\t\t\t\t<span itemprop=\"width\">2560<\/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=\"2026-10-05T14:27:13+02:00\">2026-10-05 14:27:13<\/span><span class=\"av-structured-data\" itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\">2026-10-18 18:13:31<\/span><span class=\"av-structured-data\" itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\"><span itemprop=\"name\">Pharma Smart Manufacturing 2026 in Copenhagen: QFINITY workshop on <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.\" class=\"encyclopedia\">Data Integrity<\/a> and <a href=\"https:\/\/q-finity.de\/en\/glossar\/alcoa\/\" target=\"_self\" title=\"ALCOA is a common acronym summarizing the criteria of data integrity (the ALCOA principles). It stands for: Attributable (i.e., identification of the source, the data originator - person, device, or system) Legible (and understandable) Contemporaneous (i.e., recorded at the time) Original (the initial record itself - paper-based or electronic - or a certified\/true copy) Accurate&hellip;\" class=\"encyclopedia\">ALCOA<\/a>++ in digital manufacturing systems<\/span><\/span><\/span><\/article><article class=\"post-entry post-entry-type-standard post-entry-17132 post-loop-2 post-parity-even single-big with-slider post-17132 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: How does agentic AI become possible in GxP? QFINITY brings the governance perspective to an SAP expert workshop\"><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\/agentic-ai-gxp-sap-expert-workshop\/\" rel=\"bookmark\" title=\"Permanent Link: How does agentic AI become possible in GxP? QFINITY brings the governance perspective to an SAP expert workshop\">How does agentic AI become possible in GxP? QFINITY brings the governance perspective to an SAP expert workshop<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\/agentic-ai-gxp-sap-expert-workshop\/\" title=\"SAP-Expertenworkshop Walldorf 2026-08-18\"><img data-opt-id=960415013  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\/09\/sap-expertenworkshop-walldorf-2026-08-18.jpg\" class=\"wp-image-17133 avia-img-lazy-loading-17133 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"Participants of the SAP expert workshop on AI in regulated pharma processes in front of the welcome wall in Walldorf, August 18, 2026\"><\/a><\/div><div class=\"entry-content\" itemprop=\"text\"><p><em>Recap of the SAP expert workshop on AI in regulated pharma processes, Walldorf, August 18, 2026.<\/em><\/p>\n<p class=\"qf-abstract\">On August 18, 2026, QFINITY, represented by Oliver Herrmann, brought the governance perspective to an SAP expert workshop on AI in regulated pharma processes. The workshop followed an ecosystem format: selected organizations each represented their role, SAP as the vendor, Merck for the regulated industry, alongside specialists in governance, validation and guardrails. They work on the same questions because none of them can solve them alone, and these questions concern everyone in a regulated environment. Who is accountable when agentic AI is deployed in GxP processes? And how do you know that the answer holds up?<\/p>\n<h2>What the vendor delivers and what stays with the customer<\/h2>\n<p>QFINITY&rsquo;s contribution followed one principle: the software vendor delivers the technical capability, embedded in a GxP-shaped governance that fits the governance systems of its users. What no vendor can deliver is the regulatory accountability of each individual customer. It arises on the customer&rsquo;s side: in their own governance, in the validation of the systems in their own process, in their own controls.<\/p>\n<p>The structural challenge behind this is an asymmetry. One product governance meets many governance systems of regulated users, and each of those users carries its GxP accountability itself, including for outsourced activities, as Annex 11 provides in its section on suppliers and service providers. That asymmetry is built into the structure, and harmonization alone does not resolve it. It takes defined interfaces where evidence crosses the boundary: model changes, provenance of training data, monitoring signals, audit rights reaching into the supply chain of the model providers.<\/p>\n<p class=\"qf-keyq\">The capability is delivered. The accountability is not.<\/p>\n<h2>The human stays accountable<\/h2>\n<p><a class=\"textlink\" href=\"https:\/\/q-finity.de\/en\/ai-governance-and-human-oversight-in-the-gxp-environment\/\">Human oversight<\/a> does not mean that a human is involved. The test question is: can that person still intervene and stop? This holds at every level, up to the roles that personally answer for what is released. We therefore put three questions to every agentic system, whatever the vendor:<\/p>\n<ul>\n<li>Can every action of an agent be attributed to an identifiable actor in the audit trail?<\/li>\n<li>Is a change in behavior detected without a version change?<\/li>\n<li>Are there defined paths for stop, rollback and re-verification?<\/li>\n<\/ul>\n<p>In our ISPE iSpeak article <a class=\"textlink\" href=\"https:\/\/q-finity.de\/en\/company\/publications\/human-in-the-loop-illusion-of-control\/\">Human-in-the-Loop as an Illusion of Control?<\/a> we explain why the involvement of a human alone is not yet a control.<\/p>\n<h2>The yardstick is patient safety<\/h2>\n<p>The real yardstick of our industry applies to every activity: patient safety, product quality and data integrity. Audits are one of many controls in that picture. Good AI governance is not glamorous, it is downright unexciting. Instead of a dramatic stop, it shows in decisions that were carefully weighed before risks occur. The question we expect from an auditor is therefore no longer whether an AI policy exists, but: &ldquo;Show me where your AI governance decisively shaped a decision.&rdquo; The architecture has to be prepared for that question today.<\/p>\n<h2>Why we have a say here<\/h2>\n<p>These questions are not new to QFINITY. Supplier accountability, validation evidence and human responsibility have been our daily work for <span data-qf-metric=\"years\">22<\/span> years, for <span data-qf-metric=\"clients\">200<\/span> clients in more than 20 countries, on the core team of <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> Second Edition and in the author teams of GAMP Good Practice Guides, from the RDI guide on data integrity to the eClinical guide. What is new is the context: AI is now arriving in regulated processes. Our role in this is that of the translator between the expectations of regulated users and those of the software vendor.<\/p>\n<h2>What comes next<\/h2>\n<p>The discussion continues. In October, Oliver Herrmann and Martin Heitmann take the topic to the <a class=\"textlink\" href=\"https:\/\/q-finity.de\/en\/2026-ispe-annual-meeting-expo-with-qfinity-october-18-21-2026\/\">ISPE Annual Meeting &amp; Expo<\/a> in Washington, D.C., with their talk &ldquo;Progressive QA in AI-Enabled GxP Environments&rdquo; on October 21. In December, QFINITY and Merck share the stage again. At the <a class=\"textlink\" href=\"https:\/\/q-finity.de\/en\/19th-official-gamp-5-conference-with-qfinity-december-8-9-2026\/\">19th Official GAMP 5 Conference<\/a> in Mannheim, Oliver Herrmann and Alexander Kunz (Merck) moderate the panel &ldquo;CSV at a turning point: Is our validation ready for digital reality?&rdquo;<\/p>\n<p>If you are asking yourself which role you play in this network and how your own governance stands up to the audit question, that is a conversation we are <a class=\"textlink\" href=\"https:\/\/q-finity.de\/en\/contact\/\">glad to have<\/a>.<\/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\/09\/sap-expertenworkshop-walldorf-2026-08-18.jpg<\/span>\n\t\t\t\t\t\t<span itemprop=\"height\">883<\/span>\n\t\t\t\t\t\t<span itemprop=\"width\">1280<\/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=\"2026-09-05T12:07:02+02:00\">2026-09-05 12:07:02<\/span><span class=\"av-structured-data\" itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\">2026-09-05 12:09:17<\/span><span class=\"av-structured-data\" itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\"><span itemprop=\"name\">How does agentic AI become possible in GxP? QFINITY brings the governance perspective to an SAP expert workshop<\/span><\/span><\/span><\/article><article class=\"post-entry post-entry-type-standard post-entry-17029 post-loop-3 post-parity-odd post-entry-last single-big with-slider post-17029 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: AI in Pharma 2026 in Krak&oacute;w: QFINITY speaks on AI-Enabled Computerized System Validation\"><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\/ai-in-pharma-2026-krakow\/\" rel=\"bookmark\" title=\"Permanent Link: AI in Pharma 2026 in Krak&oacute;w: QFINITY speaks on AI-Enabled Computerized System Validation\">AI in Pharma 2026 in Krak&oacute;w: QFINITY speaks on AI-Enabled Computerized System Validation<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\/ai-in-pharma-2026-krakow\/\" title=\"ai-in-pharma-2026-krakow\"><img data-opt-id=1348130172  fetchpriority=\"high\" decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"423\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1024\/h:423\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/08\/ai-in-pharma-2026-krakow.png\" class=\"wp-image-17030 avia-img-lazy-loading-17030 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"AI in Pharma 2026 Krak&oacute;w - ISPE Poland GAMP CoP conference - QFINITY\"><\/a><\/div><div class=\"entry-content\" itemprop=\"text\"><p>On 26 and 27 October 2026, ISPE Poland and its GAMP Community of Practice host <strong>AI in Pharma 2026<\/strong> at the Novotel Krak&oacute;w Centrum, the fourth edition of this English-language conference. Over two days, four tracks cover AI in pharmaceutical practice, from &ldquo;Trusted, Safe &amp; Regulated AI&rdquo; to &ldquo;Sustainable &amp; Responsible AI&rdquo;. The event opens on 25 October with a student hackathon at AGH Krak&oacute;w, built on real-world tasks from pharmaceutical manufacturing.<\/p>\n<p>QFINITY appears on the first day of the program: <strong>Frank Henrichmann<\/strong>, Senior Executive Consultant and Chair of the GAMP Global Steering Committee, presents <strong>&ldquo;AI-Enabled <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a> &ndash; Vision and Reality&rdquo;<\/strong> in the &ldquo;Trusted, Safe &amp; Regulated AI&rdquo; track (26 October, 10:30 am). The talk measures the vision of AI-supported validation against what actually holds up in regulated environments today.<\/p>\n<p>The topic is at the core of our work. Our topic area <a href=\"https:\/\/q-finity.de\/en\/artificial-intelligence\/\">Artificial Intelligence in GxP<\/a> explains how AI is changing the <a href=\"https:\/\/q-finity.de\/en\/service-areas\/validation-of-computerized-systems\/\">validation of computerized systems<\/a>, and the <a href=\"https:\/\/q-finity.de\/en\/eu-gmp-annex-22\/\">draft EU GMP Annex 22<\/a> shows where regulatory expectations for AI in GMP are heading.<\/p>\n<p><a class=\"qf-extref\" href=\"https:\/\/aiinpharma.pl\/\" target=\"_blank\" rel=\"noopener\"><span class=\"qf-extref-text\">Program and tickets at AI in Pharma (aiinpharma.pl)<\/span><span class=\"qf-extref-arrow\">&#8599;<\/span><\/a><\/p>\n<p>Will you be in Krak&oacute;w and would like to talk about AI in GxP? Frank looks forward to meeting you there. Or <a href=\"https:\/\/q-finity.de\/en\/contact\/#formular\">book a call directly<\/a>.<\/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\/08\/ai-in-pharma-2026-krakow.png<\/span>\n\t\t\t\t\t\t<span itemprop=\"height\">576<\/span>\n\t\t\t\t\t\t<span itemprop=\"width\">1024<\/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=\"2026-08-26T12:57:29+02:00\">2026-08-26 12:57:29<\/span><span class=\"av-structured-data\" itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\">2026-10-08 17:11:13<\/span><span class=\"av-structured-data\" itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\"><span itemprop=\"name\">AI in Pharma 2026 in Krak&oacute;w: QFINITY speaks on AI-Enabled <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a><\/span><\/span><\/span><\/article><div class=\"single-big\"><nav class=\"pagination\"><span class=\"pagination-meta\">Page 1 of 18<\/span><span class=\"current\">1<\/span><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4961\/page\/2\/\" class=\"inactive next_page\">2<\/a><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4961\/page\/3\/\" class=\"inactive\">3<\/a><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4961\/page\/2\/\">&rsaquo;<\/a><a href=\"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4961\/page\/18\/\">&raquo;<\/a><\/nav>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"On 26 and 27 October 2026, ISPE Poland and its GAMP Community of Practice host AI in Pharma 2026 at the Novotel Krak&oacute;w Centrum, the fourth edition of this English-language conference. Over two days, four tracks cover AI in pharmaceutical&hellip;","protected":false},"author":2,"featured_media":15296,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4961","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.5 (Yoast SEO v28.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Events - Meet QFINITY<\/title>\n<meta name=\"description\" content=\"Conferences, talks and webinars with QFINITY - regulars at ISPE and ACDM events. 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