{"id":8097,"date":"2023-03-17T10:04:36","date_gmt":"2023-03-17T09:04:36","guid":{"rendered":"https:\/\/q-finity.de\/?p=8097"},"modified":"2026-07-07T14:50:09","modified_gmt":"2026-07-07T12:50:09","slug":"april-18-2023-lounges-in-karlsruhe","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/","title":{"rendered":"April 18, 2023 | Lounges in Karlsruhe"},"content":{"rendered":"<p>Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe.<\/p>\n<p>Oliver Herrmann will give a presentation titled <span class=\"TextRun SCXW242898520 BCX4\" lang=\"DE-DE\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW242898520 BCX4\">GAMP&reg;5 &ndash; 2nd Edition<\/span> <span class=\"NormalTextRun SCXW242898520 BCX4\">&ndash; Applying the Key<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SpellingErrorHighlight SCXW242898520 BCX4\">Principles<\/span> <span class=\"NormalTextRun SCXW242898520 BCX4\">to enable Innovation<\/span><\/span><\/p>\n<p><span data-contrast=\"none\">The presentation will<\/span> <span data-contrast=\"none\">provide an introduction to the key principles <\/span><span data-contrast=\"none\"> 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 how they apply in an ever-changing world. It will also briefly introduce the new GAMP Guides. Key challenges arise in the areas of <a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">Critical Thinking<\/a>\/CSA\/RBA, AI, Agile and IS (Cloud) Management. The presentation will also give an overview and share first practical experiences of applying these special topics and implementing them in projects in an integrated way.<\/span><\/p>\n<p>Frank Henrichmann will give a presentation titled <span class=\"TextRun SCXW228412906 BCX4\" lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW228412906 BCX4\">GAMP 5 Second Edition<\/span> &ndash; <span class=\"NormalTextRun SpellingErrorV2Themed SCXW228412906 BCX4\">Specifying<\/span><\/span> <span class=\"EOP SCXW228412906 BCX4\" data-ccp-props=\"{}\">Requirements<\/span><\/p>\n<p><span class=\"TextRun SCXW227108283 BCX4\" lang=\"DE-DE\" xml:lang=\"DE-DE\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW227108283 BCX4\">The presentation will provide an introduction to GAMP 5 Second Edition in general and then explore<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SpellingErrorHighlight SCXW227108283 BCX4\">Requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\"> Management. After all, GAMP is embracing agile methodologies and the traditional separation into User <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">Requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\">,<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">Functional<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">requirements<\/span> <span class=\"NormalTextRun SCXW227108283 BCX4\">and other<\/span> <span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\"> is no longer present in the guide. However, some things did not change. Bad <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">Requirements<\/span><span class=\"NormalTextRun SCXW227108283 BCX4\"> are still bad, whether expressed as user stories in a system or in a specification document. And bad <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW227108283 BCX4\">requirements<\/span> <span class=\"NormalTextRun SCXW227108283 BCX4\">inevitably lead to systems that are not fit for purpose and do not meet regulatory expectations.<\/span><\/span><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Oliver Herrmann (CEO and founder of QFINITY) and Frank Henrichmann (Senior Executive Consultant at QFINITY) will give two presentations at the Lounges in Karlsruhe. Oliver Herrmann will give a presentation titled GAMP\u00ae5 &#8211; 2nd Edition &#8211; Applying the Key Principles to enable Innovation The presentation will provide an introduction to the key principles of GAMP [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":10427,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[38],"tags":[],"class_list":["post-8097","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-meet-qfinity-en"],"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>Lounges Karlsruhe: GAMP 5 2nd Edition | QFINITY<\/title>\n<meta name=\"description\" content=\"At Lounges 2023 in Karlsruhe, QFINITY was represented with two talks - Oliver Herrmann covered the GAMP 5 Second Edition key principles on April 18.\" \/>\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\/april-18-2023-lounges-in-karlsruhe\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lounges Karlsruhe: GAMP 5 2nd Edition | QFINITY\" \/>\n<meta property=\"og:description\" content=\"At Lounges 2023 in Karlsruhe, QFINITY was represented with two talks - Oliver Herrmann covered the GAMP 5 Second Edition key principles on April 18.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/april-18-2023-lounges-in-karlsruhe\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:published_time\" content=\"2023-03-17T09:04:36+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-07T12:50:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/03\/Bildschirmfoto-2023-07-20-um-09.42.01-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1084\" \/>\n\t<meta property=\"og:image:height\" content=\"382\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"oherrmann\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"April 18, 2023 | Lounges in Karlsruhe\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"oherrmann\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/\"},\"author\":{\"name\":\"oherrmann\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#\\\/schema\\\/person\\\/f9dc643267b45b803521d7382f1283b4\"},\"headline\":\"April 18, 2023 | Lounges in Karlsruhe\",\"datePublished\":\"2023-03-17T09:04:36+00:00\",\"dateModified\":\"2026-07-07T12:50:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/\"},\"wordCount\":221,\"publisher\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2023\\/03\\/Bildschirmfoto-2023-07-20-um-09.42.01-1.png\",\"articleSection\":[\"Meet Qfinity\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/\",\"name\":\"Lounges Karlsruhe: GAMP 5 2nd Edition | QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/april-18-2023-lounges-in-karlsruhe\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2023\\/03\\/Bildschirmfoto-2023-07-20-um-09.42.01-1.png\",\"datePublished\":\"2023-03-17T09:04:36+00:00\",\"dateModified\":\"2026-07-07T12:50:09+00:00\",\"description\":\"At Lounges 2023 in Karlsruhe, QFINITY was represented with two talks - 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