{"id":38972,"date":"2026-08-21T17:46:28","date_gmt":"2026-08-21T17:46:28","guid":{"rendered":"https:\/\/orise.com\/?page_id=38972"},"modified":"2026-09-02T18:25:28","modified_gmt":"2026-09-02T18:25:28","slug":"csv-compliance-checkliste","status":"publish","type":"page","link":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/","title":{"rendered":"CSV Compliance Checklist"},"content":{"rendered":"<div id=\"pageheader-block_33d92dfba92de4cb1d7731a3554798ca\" class=\"content-row content-row-pageheader background_blue pageheader\">\n        <div class=\"contentPart-fixed\">\n        <div class=\"contentPart-inner\">\n            <div class=\"contentPart-text width-100\">\n                <h1>\n                                        F\u00fcllen Sie das Formular aus und laden Sie die CSV Compliance Checklist f\u00fcr Pharma &amp; Biotech herunter                                    <\/h1>\n                                                            <\/div>\n        <\/div>\n    <\/div>\n    <div class=\"slidedown-button editor-hide\">\n        <span class=\"slidedown-label\">Mehr erfahren<\/span>\n        <img decoding=\"async\" src=\"https:\/\/orise.com\/wp-content\/themes\/ats-orise\/img\/doubble-arrow-down.svg\" alt=\"\"\n            class=\"slidedown-icon\">\n    <\/div>\n<\/div>\n\n\n    <div id=\"contactform-block_5e933fd8f7b925064eba20e7a9b66ae1\" class=\"content-row content-row-contactform  background_darken contactform\">\n        <div class=\"contentPart-inner\">\n\n            <div class=\"contentPart-text width-100\">\n                            <\/div>\n\n            <div class=\"contactform-wrapper trans\">\n                                    <iframe src=\"https:\/\/go.orise.com\/l\/651873\/2026-08-20\/h8qysd\" class=\"form-iframe form-iframe-contactform\" data-cookieconsent=\"marketing\"><\/iframe>\n                            <\/div>\n\n        <\/div>\n    <\/div>\n\n\n    <div id=\"singletext-block_9a9338af0de2d34a45c31bdb3b658d0a\" class=\"content-row content-row-singletext bg-base   singletext\">\n        <div class=\"contentPart-inner\">\n            <div class=\"contentPart-text width-100\">\n                                <div class=\"contentPart-textbox textInput trans\">\n                    <table>\n<tbody>\n<tr>\n<td><strong>43 Pr\u00fcfpunkte zu GAMP 5, 21 CFR Part 11, EU GMP Annex 11 und PIC\/S-Datenintegrit\u00e4t, plus eine 8-Punkte-Bereitschaftspr\u00fcfung f\u00fcr den Annex-11-Entwurf 2025 und den neuen Annex 22 zu KI.<\/strong><\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<tr>\n<td><strong>Die meisten computergest\u00fctzten GxP-Systeme bestehen ihre eigene Validierungspr\u00fcfung. Was Teams bei einer Inspektion ins Straucheln bringt, ist die Umsetzung: Schnittstellen, die au\u00dferhalb des Validierungsumfangs blieben, Audit Trails, die den vorherigen Wert nie erfasst haben, Zugriffspr\u00fcfungen, die nie eingeplant wurden, eine Wiederherstellung, die nie getestet wurde.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/td>\n<\/tr>\n<tr>\n<td><strong>GAMP 5\u00a0 \u00a0\u00b7\u00a0 \u00a0 21 CFR PART 11\u00a0 \u00a0\u00b7\u00a0 \u00a0EU ANNEX 11\u00a0 \u00a0\u00b7\u00a0 \u00a0 ICH Q9(R1)\u00a0 \u00a0\u00b7\u00a0 \u00a0PIC\/S PI 041-1<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":617,"featured_media":36867,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_cr_original_post":"","_cr_replace_post_id":"","_cr_replacing_post_id":"","footnotes":""},"class_list":["post-38972","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 v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CSV Compliance Checklist | Orise<\/title>\n<meta name=\"description\" content=\"43 Pr\u00fcfungen \u00fcber GAMP 5, 21 CFR Part 11, EU-GMP Annex 11 und PIC\/S Datenintegrit\u00e4t hinweg \u2014 plus ein 8-Punkte-Bereitschaftscheck f\u00fcr den Entwurf des Annex 11 von 2025 und den neuen Annex 22 zu KI.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/orise.com\/de\/csv-compliance-checkliste\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CSV Compliance Checklist | Orise\" \/>\n<meta property=\"og:description\" content=\"43 Pr\u00fcfungen \u00fcber GAMP 5, 21 CFR Part 11, EU-GMP Annex 11 und PIC\/S Datenintegrit\u00e4t hinweg \u2014 plus ein 8-Punkte-Bereitschaftscheck f\u00fcr den Entwurf des Annex 11 von 2025 und den neuen Annex 22 zu KI.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/orise.com\/de\/csv-compliance-checkliste\/\" \/>\n<meta property=\"og:site_name\" content=\"Orise\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-02T18:25:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"700\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 Minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/\",\"url\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/\",\"name\":\"CSV Compliance Checklist | Orise\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/orise.com\\\/wp-content\\\/uploads\\\/sites\\\/71\\\/2026\\\/05\\\/Frame-106-3.png\",\"datePublished\":\"2026-08-21T17:46:28+00:00\",\"dateModified\":\"2026-09-02T18:25:28+00:00\",\"description\":\"43 Pr\u00fcfungen \u00fcber GAMP 5, 21 CFR Part 11, EU-GMP Annex 11 und PIC\\\/S Datenintegrit\u00e4t hinweg \u2014 plus ein 8-Punkte-Bereitschaftscheck f\u00fcr den Entwurf des Annex 11 von 2025 und den neuen Annex 22 zu KI.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/#breadcrumb\"},\"inLanguage\":\"de-DE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de-DE\",\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/#primaryimage\",\"url\":\"https:\\\/\\\/orise.com\\\/wp-content\\\/uploads\\\/sites\\\/71\\\/2026\\\/05\\\/Frame-106-3.png\",\"contentUrl\":\"https:\\\/\\\/orise.com\\\/wp-content\\\/uploads\\\/sites\\\/71\\\/2026\\\/05\\\/Frame-106-3.png\",\"width\":1920,\"height\":700},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/csv-compliance-checkliste\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/orise.com\\\/de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CSV Compliance Checklist\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/#website\",\"url\":\"https:\\\/\\\/orise.com\\\/de\\\/\",\"name\":\"Orise\",\"description\":\"Unlock your full potential.\",\"publisher\":{\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/orise.com\\\/de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de-DE\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/#organization\",\"name\":\"Orise\",\"url\":\"https:\\\/\\\/orise.com\\\/de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de-DE\",\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/orise.com\\\/wp-content\\\/uploads\\\/sites\\\/71\\\/2025\\\/04\\\/cropped-Orise-Circle-Icon-Website-V1-1.png\",\"contentUrl\":\"https:\\\/\\\/orise.com\\\/wp-content\\\/uploads\\\/sites\\\/71\\\/2025\\\/04\\\/cropped-Orise-Circle-Icon-Website-V1-1.png\",\"width\":512,\"height\":512,\"caption\":\"Orise\"},\"image\":{\"@id\":\"https:\\\/\\\/orise.com\\\/de\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"CSV Compliance Checklist | Orise","description":"43 Pr\u00fcfungen \u00fcber GAMP 5, 21 CFR Part 11, EU-GMP Annex 11 und PIC\/S Datenintegrit\u00e4t hinweg \u2014 plus ein 8-Punkte-Bereitschaftscheck f\u00fcr den Entwurf des Annex 11 von 2025 und den neuen Annex 22 zu KI.","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:\/\/orise.com\/de\/csv-compliance-checkliste\/","og_locale":"de_DE","og_type":"article","og_title":"CSV Compliance Checklist | Orise","og_description":"43 Pr\u00fcfungen \u00fcber GAMP 5, 21 CFR Part 11, EU-GMP Annex 11 und PIC\/S Datenintegrit\u00e4t hinweg \u2014 plus ein 8-Punkte-Bereitschaftscheck f\u00fcr den Entwurf des Annex 11 von 2025 und den neuen Annex 22 zu KI.","og_url":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/","og_site_name":"Orise","article_modified_time":"2026-09-02T18:25:28+00:00","og_image":[{"width":1920,"height":700,"url":"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Gesch\u00e4tzte Lesezeit":"1 Minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/","url":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/","name":"CSV Compliance Checklist | Orise","isPartOf":{"@id":"https:\/\/orise.com\/de\/#website"},"primaryImageOfPage":{"@id":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/#primaryimage"},"image":{"@id":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/#primaryimage"},"thumbnailUrl":"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png","datePublished":"2026-08-21T17:46:28+00:00","dateModified":"2026-09-02T18:25:28+00:00","description":"43 Pr\u00fcfungen \u00fcber GAMP 5, 21 CFR Part 11, EU-GMP Annex 11 und PIC\/S Datenintegrit\u00e4t hinweg \u2014 plus ein 8-Punkte-Bereitschaftscheck f\u00fcr den Entwurf des Annex 11 von 2025 und den neuen Annex 22 zu KI.","breadcrumb":{"@id":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/#breadcrumb"},"inLanguage":"de-DE","potentialAction":[{"@type":"ReadAction","target":["https:\/\/orise.com\/de\/csv-compliance-checkliste\/"]}]},{"@type":"ImageObject","inLanguage":"de-DE","@id":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/#primaryimage","url":"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png","contentUrl":"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png","width":1920,"height":700},{"@type":"BreadcrumbList","@id":"https:\/\/orise.com\/de\/csv-compliance-checkliste\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/orise.com\/de\/"},{"@type":"ListItem","position":2,"name":"CSV Compliance Checklist"}]},{"@type":"WebSite","@id":"https:\/\/orise.com\/de\/#website","url":"https:\/\/orise.com\/de\/","name":"Orise","description":"Unlock your full potential.","publisher":{"@id":"https:\/\/orise.com\/de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/orise.com\/de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de-DE"},{"@type":"Organization","@id":"https:\/\/orise.com\/de\/#organization","name":"Orise","url":"https:\/\/orise.com\/de\/","logo":{"@type":"ImageObject","inLanguage":"de-DE","@id":"https:\/\/orise.com\/de\/#\/schema\/logo\/image\/","url":"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2025\/04\/cropped-Orise-Circle-Icon-Website-V1-1.png","contentUrl":"https:\/\/orise.com\/wp-content\/uploads\/sites\/71\/2025\/04\/cropped-Orise-Circle-Icon-Website-V1-1.png","width":512,"height":512,"caption":"Orise"},"image":{"@id":"https:\/\/orise.com\/de\/#\/schema\/logo\/image\/"}}]}},"acf":[],"jetpack-related-posts":[{"id":38786,"url":"https:\/\/orise.com\/csv-compliance-checklist\/","url_meta":{"origin":38972,"position":0},"title":"CSV Compliance Checklist","author":"\u042e\u043b\u0456\u044f","date":"August 21, 2026","format":false,"excerpt":"","rel":"","context":"\u00c4hnlicher Beitrag","block_context":{"text":"\u00c4hnlicher Beitrag","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":38975,"url":"https:\/\/orise.com\/it\/checklist-conformita-csv\/","url_meta":{"origin":38972,"position":1},"title":"CSV Compliance Checklist","author":"\u042e\u043b\u0456\u044f","date":"August 21, 2026","format":false,"excerpt":"","rel":"","context":"\u00c4hnlicher Beitrag","block_context":{"text":"\u00c4hnlicher Beitrag","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":38979,"url":"https:\/\/orise.com\/nl\/csv-nalevingschecklist\/","url_meta":{"origin":38972,"position":2},"title":"CSV Compliance Checklist","author":"\u042e\u043b\u0456\u044f","date":"August 21, 2026","format":false,"excerpt":"","rel":"","context":"\u00c4hnlicher Beitrag","block_context":{"text":"\u00c4hnlicher Beitrag","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/orise.com\/wp-content\/uploads\/sites\/71\/2026\/05\/Frame-106-3.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":24947,"url":"https:\/\/orise.com\/nl\/csv-csa-project-delivery\/","url_meta":{"origin":38972,"position":3},"title":"CSV and CSA Project Delivery","author":"","date":"Februar 24, 2025","format":false,"excerpt":"","rel":"","context":"\u00c4hnlicher Beitrag","block_context":{"text":"\u00c4hnlicher Beitrag","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":24948,"url":"https:\/\/orise.com\/de\/csv-csa-project-delivery\/","url_meta":{"origin":38972,"position":4},"title":"CSV and CSA Project Delivery","author":"","date":"Februar 24, 2025","format":false,"excerpt":"","rel":"","context":"\u00c4hnlicher Beitrag","block_context":{"text":"\u00c4hnlicher Beitrag","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":24949,"url":"https:\/\/orise.com\/it\/csv-csa-project-delivery\/","url_meta":{"origin":38972,"position":5},"title":"CSV and CSA Project Delivery ITAdd title","author":"","date":"Februar 24, 2025","format":false,"excerpt":"","rel":"","context":"\u00c4hnlicher Beitrag","block_context":{"text":"\u00c4hnlicher Beitrag","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/pages\/38972","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/users\/617"}],"replies":[{"embeddable":true,"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/comments?post=38972"}],"version-history":[{"count":3,"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/pages\/38972\/revisions"}],"predecessor-version":[{"id":38988,"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/pages\/38972\/revisions\/38988"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/media\/36867"}],"wp:attachment":[{"href":"https:\/\/orise.com\/de\/wp-json\/wp\/v2\/media?parent=38972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}