{"id":4888,"date":"2021-03-02T14:18:06","date_gmt":"2021-03-02T13:18:06","guid":{"rendered":"https:\/\/q-finity.de\/bereiche\/die-digitale-transformation-im-gxp-regulierten-umfeld\/"},"modified":"2026-07-26T08:48:31","modified_gmt":"2026-07-26T06:48:31","slug":"the-digital-transformation-in-gxp-regulated-fields","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/","title":{"rendered":"The digital transformation in GxP regulated fields"},"content":{"rendered":"\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":16417,"parent":4876,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4888","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>Digital Transformation in GxP | QFINITY<\/title>\n<meta name=\"description\" content=\"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.\" \/>\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\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digital Transformation in GxP | QFINITY\" \/>\n<meta property=\"og:description\" content=\"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-26T06:48:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1030\/h:575\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/digitale-transformation-hero-v5.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1030\" \/>\n\t<meta property=\"og:image:height\" content=\"575\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"The digital transformation in GxP regulated fields\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/\",\"name\":\"Digital Transformation in GxP | QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/07\\/digitale-transformation-hero-v5-scaled.png\",\"datePublished\":\"2021-03-02T13:18:06+00:00\",\"dateModified\":\"2026-07-26T06:48:31+00:00\",\"description\":\"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#primaryimage\",\"url\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/07\\/digitale-transformation-hero-v5-scaled.png\",\"contentUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/07\\/digitale-transformation-hero-v5-scaled.png\",\"width\":2560,\"height\":1429,\"caption\":\"Digitale Transformation GxP - QFINITY\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Areas\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"The digital transformation in GxP regulated fields\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; - sicherung\",\"publisher\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/q-finity.de\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\",\"name\":\"QFINITY\u221e\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\/\\/mlsqau6zetur.i.optimole.com\\/cb:frAi.c2d9\\/w:512\\/h:512\\/q:mauto\\/f:best\\/https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2021\\/03\\/cropped-cropped-signet_PAN_orange.png\",\"contentUrl\":\"https:\\/\\/mlsqau6zetur.i.optimole.com\\/cb:frAi.c2d9\\/w:512\\/h:512\\/q:mauto\\/f:best\\/https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2021\\/03\\/cropped-cropped-signet_PAN_orange.png\",\"width\":512,\"height\":512,\"caption\":\"QFINITY\u221e\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/company\\\/q-finity-quality-management\\\/\",\"https:\\\/\\\/www.instagram.com\\\/qfinity_official\\\/\"],\"founder\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#founder\"}},{\"@type\":\"FAQPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#faq\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Does GxP slow down digital transformation?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"No. The regulations demand risk understanding and controlled processes - not maximum documentation volume. What slows transformation down are usually a company's own assumptions: over-documentation as supposed safety, and fear of the inspection. The regulations themselves are taking the risk-based path - from the FDA's CSA guidance to the drafts of Annex 11 and Annex 22.\"}},{\"@type\":\"Question\",\"name\":\"Are we allowed to use tools in validation?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. No regulation prohibits tool-supported validation - quite the opposite: the current Annex 11 has explicitly provided for automated testing tools since 2011, the FDA confirms the route with the CSA guidance, and the draft Annex 11 stays on this line - tools for requirements traceability and audit trail review are literally \\\"encouraged\\\". What counts is the evidence, not the medium: record-based methods create the evidence where it comes into being, and they are more efficient than downstream documentation. The prerequisites are a defined intended use and a risk-based approach for each tool.\"}},{\"@type\":\"Question\",\"name\":\"Is AI-supported work permitted in a GxP environment?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes - it is not prohibited outright; it wants to be approached wisely: through governance, defined use cases and risk analyses. That is exactly the order the EU AI Act lays out, and the draft Annex 22 formulates GMP expectations for AI for the first time. Where limits apply - under the draft Annex 22, generative AI should not be used in critical GMP applications - they follow from risk, not from a blanket ban: in non-critical applications its use with a human-in-the-loop is explicitly foreseen. What this looks like in practice is shown in our topic area Artificial Intelligence in GxP.\"}},{\"@type\":\"Question\",\"name\":\"Do we have to validate every new tool?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Not every one - and never the tool alone. What is validated is the application in the process: the process defines the intended use, and risk and depth of evidence follow from it. A tool with no influence on the chain from data to product to patient needs no validation effort; a critical one needs targeted evidence instead of maximum formality.\"}},{\"@type\":\"Question\",\"name\":\"What does a maturity assessment give us?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The groundwork for every investment decision. It shows honestly where culture, processes and systems stand and what capacity to deliver exists. The result is a roadmap that fits your maturity - instead of a technology decision without a foundation.\"}}],\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/\"}},{\"@type\":\"Service\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/#service\",\"name\":\"The digital transformation in GxP regulated fields\",\"serviceType\":\"The digital transformation in GxP regulated fields\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/\",\"areaServed\":[{\"@type\":\"Country\",\"name\":\"Germany\"},{\"@type\":\"Country\",\"name\":\"Austria\"},{\"@type\":\"Country\",\"name\":\"Switzerland\"}],\"description\":\"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.\",\"provider\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/service-areas\\\/the-digital-transformation-in-gxp-regulated-fields\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#founder\",\"name\":\"Oliver Herrmann\",\"jobTitle\":\"Founder & CEO\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"worksFor\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"sameAs\":[\"https:\\\/\\\/www.linkedin.com\\\/in\\\/olherrmann\\\/\",\"https:\\\/\\\/virtual.ispe.org\\\/b\\\/sp\\\/oliver-herrmann-4399\"],\"knowsAbout\":[\"GxP-Compliance\",\"Computer System Validation\",\"Computer Software Assurance\",\"Data Integrity\",\"ALCOA++\",\"AI Governance\",\"GAMP 5\"],\"image\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/06\\/oliver-herrmann-qfinity-ceo-scaled.jpg\",\"description\":\"Founder and CEO of QFINITY, GAMP Europe Chair, qualified GAMP 5 and GAMP Data Integrity trainer, GQMA auditor and international speaker. Co-author of several ISPE GAMP guides, including the GAMP 5 Guide (2nd Edition).\",\"memberOf\":{\"@type\":\"Organization\",\"name\":\"International Society for Pharmaceutical Engineering (ISPE)\",\"url\":\"https:\\\/\\\/ispe.org\"},\"hasCredential\":[{\"@type\":\"EducationalOccupationalCredential\",\"credentialCategory\":\"degree\",\"name\":\"Graduate Computer Scientist (Dipl.-Inf.)\"},{\"@type\":\"EducationalOccupationalCredential\",\"credentialCategory\":\"certification\",\"name\":\"Microsoft Certified Systems Engineer (MCSE)\"},{\"@type\":\"EducationalOccupationalCredential\",\"credentialCategory\":\"certification\",\"name\":\"SAFe (Scaled Agile Framework)\"}]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Digital Transformation in GxP | QFINITY","description":"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/","og_locale":"en_US","og_type":"article","og_title":"Digital Transformation in GxP | QFINITY","og_description":"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.","og_url":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/","og_site_name":"QFINITY","article_modified_time":"2026-07-26T06:48:31+00:00","og_image":[{"width":1030,"height":575,"url":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1030\/h:575\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/digitale-transformation-hero-v5.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_title":"The digital transformation in GxP regulated fields","twitter_misc":{"Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/","url":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/","name":"Digital Transformation in GxP | QFINITY","isPartOf":{"@id":"https:\/\/q-finity.de\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#primaryimage"},"image":{"@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#primaryimage"},"thumbnailUrl":"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\/digitale-transformation-hero-v5-scaled.png","datePublished":"2021-03-02T13:18:06+00:00","dateModified":"2026-07-26T06:48:31+00:00","description":"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.","breadcrumb":{"@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#primaryimage","url":"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\/digitale-transformation-hero-v5-scaled.png","contentUrl":"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\/digitale-transformation-hero-v5-scaled.png","width":2560,"height":1429,"caption":"Digitale Transformation GxP - QFINITY"},{"@type":"BreadcrumbList","@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/q-finity.de\/en\/home\/"},{"@type":"ListItem","position":2,"name":"Areas","item":"https:\/\/q-finity.de\/en\/service-areas\/"},{"@type":"ListItem","position":3,"name":"The digital transformation in GxP regulated fields"}]},{"@type":"WebSite","@id":"https:\/\/q-finity.de\/en\/#website","url":"https:\/\/q-finity.de\/en\/","name":"QFINITY","description":"Qualit\u00e4tsmanagement &amp; - sicherung","publisher":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/q-finity.de\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/q-finity.de\/en\/#organization","name":"QFINITY\u221e","url":"https:\/\/q-finity.de\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/q-finity.de\/en\/#\/schema\/logo\/image\/","url":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:512\/h:512\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/cropped-cropped-signet_PAN_orange.png","contentUrl":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:512\/h:512\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/cropped-cropped-signet_PAN_orange.png","width":512,"height":512,"caption":"QFINITY\u221e"},"image":{"@id":"https:\/\/q-finity.de\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/q-finity-quality-management\/","https:\/\/www.instagram.com\/qfinity_official\/"],"founder":{"@id":"https:\/\/q-finity.de\/en\/#founder"}},{"@type":"FAQPage","@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#faq","mainEntity":[{"@type":"Question","name":"Does GxP slow down digital transformation?","acceptedAnswer":{"@type":"Answer","text":"No. The regulations demand risk understanding and controlled processes - not maximum documentation volume. What slows transformation down are usually a company's own assumptions: over-documentation as supposed safety, and fear of the inspection. The regulations themselves are taking the risk-based path - from the FDA's CSA guidance to the drafts of Annex 11 and Annex 22."}},{"@type":"Question","name":"Are we allowed to use tools in validation?","acceptedAnswer":{"@type":"Answer","text":"Yes. No regulation prohibits tool-supported validation - quite the opposite: the current Annex 11 has explicitly provided for automated testing tools since 2011, the FDA confirms the route with the CSA guidance, and the draft Annex 11 stays on this line - tools for requirements traceability and audit trail review are literally \"encouraged\". What counts is the evidence, not the medium: record-based methods create the evidence where it comes into being, and they are more efficient than downstream documentation. The prerequisites are a defined intended use and a risk-based approach for each tool."}},{"@type":"Question","name":"Is AI-supported work permitted in a GxP environment?","acceptedAnswer":{"@type":"Answer","text":"Yes - it is not prohibited outright; it wants to be approached wisely: through governance, defined use cases and risk analyses. That is exactly the order the EU AI Act lays out, and the draft Annex 22 formulates GMP expectations for AI for the first time. Where limits apply - under the draft Annex 22, generative AI should not be used in critical GMP applications - they follow from risk, not from a blanket ban: in non-critical applications its use with a human-in-the-loop is explicitly foreseen. What this looks like in practice is shown in our topic area Artificial Intelligence in GxP."}},{"@type":"Question","name":"Do we have to validate every new tool?","acceptedAnswer":{"@type":"Answer","text":"Not every one - and never the tool alone. What is validated is the application in the process: the process defines the intended use, and risk and depth of evidence follow from it. A tool with no influence on the chain from data to product to patient needs no validation effort; a critical one needs targeted evidence instead of maximum formality."}},{"@type":"Question","name":"What does a maturity assessment give us?","acceptedAnswer":{"@type":"Answer","text":"The groundwork for every investment decision. It shows honestly where culture, processes and systems stand and what capacity to deliver exists. The result is a roadmap that fits your maturity - instead of a technology decision without a foundation."}}],"isPartOf":{"@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/"}},{"@type":"Service","@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/#service","name":"The digital transformation in GxP regulated fields","serviceType":"The digital transformation in GxP regulated fields","url":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/","areaServed":[{"@type":"Country","name":"Germany"},{"@type":"Country","name":"Austria"},{"@type":"Country","name":"Switzerland"}],"description":"Digital transformation in GxP: no blanket ban on tools and AI. Record-based, tool-supported, risk-based - the regulations confirm the path.","provider":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"isPartOf":{"@id":"https:\/\/q-finity.de\/en\/service-areas\/the-digital-transformation-in-gxp-regulated-fields\/"}},{"@type":"Person","@id":"https:\/\/q-finity.de\/en\/#founder","name":"Oliver Herrmann","jobTitle":"Founder & CEO","url":"https:\/\/q-finity.de\/en\/","worksFor":{"@id":"https:\/\/q-finity.de\/en\/#organization"},"sameAs":["https:\/\/www.linkedin.com\/in\/olherrmann\/","https:\/\/virtual.ispe.org\/b\/sp\/oliver-herrmann-4399"],"knowsAbout":["GxP-Compliance","Computer System Validation","Computer Software Assurance","Data Integrity","ALCOA++","AI Governance","GAMP 5"],"image":"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/oliver-herrmann-qfinity-ceo-scaled.jpg","description":"Founder and CEO of QFINITY, GAMP Europe Chair, qualified GAMP 5 and GAMP Data Integrity trainer, GQMA auditor and international speaker. Co-author of several ISPE GAMP guides, including the GAMP 5 Guide (2nd Edition).","memberOf":{"@type":"Organization","name":"International Society for Pharmaceutical Engineering (ISPE)","url":"https:\/\/ispe.org"},"hasCredential":[{"@type":"EducationalOccupationalCredential","credentialCategory":"degree","name":"Graduate Computer Scientist (Dipl.-Inf.)"},{"@type":"EducationalOccupationalCredential","credentialCategory":"certification","name":"Microsoft Certified Systems Engineer (MCSE)"},{"@type":"EducationalOccupationalCredential","credentialCategory":"certification","name":"SAFe (Scaled Agile Framework)"}]}]}},"_links":{"self":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4888","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/comments?post=4888"}],"version-history":[{"count":15,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4888\/revisions"}],"predecessor-version":[{"id":16420,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4888\/revisions\/16420"}],"up":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/4876"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/media\/16417"}],"wp:attachment":[{"href":"https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/media?parent=4888"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}