{"id":3286,"date":"2025-08-01T18:50:01","date_gmt":"2025-08-01T18:50:01","guid":{"rendered":"https:\/\/nano-test.de\/?p=3286"},"modified":"2025-08-01T18:59:30","modified_gmt":"2025-08-01T18:59:30","slug":"glp-und-computergestutzte-systeme-uberblick-uber-das-oecd-konsensdokument-nr-10","status":"publish","type":"post","link":"https:\/\/nano-test.de\/fr\/2025\/08\/01\/glp-und-computergestutzte-systeme-uberblick-uber-das-oecd-konsensdokument-nr-10\/","title":{"rendered":"GLP et syst\u00e8mes informatis\u00e9s : Document de consensus de l'OCDE No. 10 Pr\u00e9sentation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3286\" class=\"elementor elementor-3286\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5c37f610 ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c37f610\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-1607f78b ts-bg-color-over-image\" data-id=\"1607f78b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3a2030b9 elementor-widget elementor-widget-text-editor\" data-id=\"3a2030b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3><span style=\"color: #000000;\">GLP et transformation num\u00e9rique<\/span><\/h3><p><span style=\"color: #000000;\">Der Einsatz computergest\u00fctzter Systeme in technologisch gut ausgestatteten, kompetenten Laboren ist unverzichtbar. Da dies mittlerweile Teil der Laborprozesse ist, muss die Sicherheit, Genauigkeit und R\u00fcckverfolgbarkeit elektronischer Daten kontrolliert werden. Dies sind wichtige Punkte im Rahmen der GLP (Gute Laborpraxis), und wir k\u00f6nnen aus dem von der <a href=\"https:\/\/www.oecd.org\/en.html\">OECD<\/a> ver\u00f6ffentlichten <a href=\"https:\/\/www.oecd.org\/content\/dam\/oecd\/en\/publications\/reports\/1995\/10\/the-application-of-the-principles-of-glp-to-computerised-systems_g1gh32fb\/9789264078710-en.pdf\"><b>GLP-Konsensdokument Nr. 10 <\/b><\/a>erfahren, wie diese Punkte umgesetzt werden k\u00f6nnen.<\/span><\/p><p><span style=\"color: #000000;\">L'application des Principes du GLP aux syst\u00e8mes informatiques comprend tous les types de syst\u00e8mes informatiques utilis\u00e9s dans les travaux de GLP. Ceux-ci comprennent :<\/span><\/p><ul><li><span style=\"color: #000000;\">Syst\u00e8mes de collecte et d'analyse de donn\u00e9es<\/span><\/li><li><span style=\"color: #000000;\">Syst\u00e8mes de gestion des informations de laboratoire (LIM)<\/span><\/li><li><span style=\"color: #000000;\">Logiciel de contr\u00f4le automatique<\/span><\/li><li><span style=\"color: #000000;\">Syst\u00e8mes d'archivage \u00e9lectroniques<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Ces syst\u00e8mes assist\u00e9s par ordinateur doivent avoir une conception appropri\u00e9e et une capacit\u00e9 suffisante, avoir d\u00e9fini des proc\u00e9dures de contr\u00f4le et de maintenance appropri\u00e9es, et ont \u00e9t\u00e9 d\u00e9velopp\u00e9s et valid\u00e9s conform\u00e9ment aux principes du GLP.<\/span><\/p><p><\/p><div style=\"width: 847px;\" class=\"wp-video\"><video class=\"wp-video-shortcode\" id=\"video-3286-1\" width=\"847\" height=\"476\" loop autoplay preload=\"auto\" controls=\"controls\"><source type=\"video\/mp4\" src=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/4121354-uhd_3840_2160_25fps.mp4?_=1\"><\/source><a href=\"https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/4121354-uhd_3840_2160_25fps.mp4\">https:\/\/nano-test.de\/wp-content\/uploads\/2025\/08\/4121354-uhd_3840_2160_25fps.mp4<\/a><\/video><\/div><h3><span style=\"color: #000000;\">Aspects \u00e0 prendre en compte lors de l'application des principes du BPL \u00e0 des syst\u00e8mes informatis\u00e9s<\/span><\/h3><p><span style=\"color: #000000;\"><strong>1. Responsabilit\u00e9s\u00a0: <\/strong><\/span><span style=\"color: #000000;\">Afin d'assurer le respect des principes du GLP, les responsabilit\u00e9s du document sont \u00e9num\u00e9r\u00e9es comme suit : responsabilit\u00e9s de gestion, responsabilit\u00e9s des responsables du travail, responsabilit\u00e9s du personnel de laboratoire et responsabilit\u00e9s de l'organisme d'assurance qualit\u00e9.<\/span><\/p><p><span style=\"color: #000000;\">Kurz gesagt ist die Betriebsleitung daf\u00fcr verantwortlich, dass das Computersystem ordnungsgem\u00e4\u00df entwickelt, validiert und betrieben wird und dass <b>Richtlinien und Verfahren f\u00fcr die Datenverarbeitung<\/b> festgelegt werden.<\/span><\/p><p><span style=\"color: #000000;\">Der Arbeitsleiter muss sicherstellen, dass die im Rahmen der GLP durchgef\u00fchrten Arbeiten verwaltet werden und dass validierte Systeme verwendet werden. In diesem Zusammenhang ist das Laborpersonal daf\u00fcr verantwortlich, das System gem\u00e4\u00df den <a href=\"https:\/\/nano-test.de\/fr\/service\/gute-laborpraxis-glp\/\">GLP-Grunds\u00e4tzen<\/a> zu betreiben.<\/span><\/p><p><span style=\"color: #000000;\">Les t\u00e2ches de l'unit\u00e9 d'assurance qualit\u00e9 doivent \u00eatre clairement d\u00e9finies dans les lignes directrices et proc\u00e9dures \u00e9crites. Cela comprend la validation du syst\u00e8me, les processus op\u00e9rationnels, les mesures de maintenance et l'\u00e9valuation des syst\u00e8mes acquis et d\u00e9velopp\u00e9s en interne.<\/span><\/p><p><span style=\"color: #000000;\"><strong>2. Validation du syst\u00e8me\u00a0: <\/strong><\/span><span style=\"color: #000000;\">Chaque syst\u00e8me assist\u00e9 par ordinateur doit \u00eatre valid\u00e9 et document\u00e9 en fonction de son utilisation pr\u00e9vue. La validation garantit que le syst\u00e8me fonctionne correctement et de mani\u00e8re coh\u00e9rente.<\/span><\/p><p><strong><span style=\"color: #000000;\">3. Autorisation et contr\u00f4le d'acc\u00e8s\u00a0: <\/span><\/strong><span style=\"color: #000000;\">Il faut s'assurer que seules les personnes autoris\u00e9es peuvent acc\u00e9der au syst\u00e8me ; Les identit\u00e9s des utilisateurs, la gestion des mots de passe et les contr\u00f4les d'acc\u00e8s bas\u00e9s sur les r\u00f4les doivent \u00eatre impl\u00e9ment\u00e9s.<\/span><\/p><p><span style=\"color: #000000;\"><strong>4. Int\u00e9grit\u00e9 et s\u00e9curit\u00e9 des donn\u00e9es\u00a0: <\/strong><\/span><span style=\"color: #000000;\">Les donn\u00e9es doivent \u00eatre ind\u00e9l\u00e9biles, immuables et enregistr\u00e9es. Une piste d'audit doit \u00eatre utilis\u00e9e, chaque processus doit \u00eatre compr\u00e9hensible.<\/span><\/p><p><span style=\"color: #000000;\"><strong>5. Modifier le contr\u00f4le\u00a0: <\/strong><\/span><span style=\"color: #000000;\">Toute modification du syst\u00e8me doit \u00eatre enregistr\u00e9e et, si n\u00e9cessaire, valid\u00e9e \u00e0 nouveau. Cela s'applique \u00e9galement aux mises \u00e0 jour logicielles.<\/span><\/p><p><span style=\"color: #000000;\"><strong>6. Sauvegarde et restauration du syst\u00e8me\u00a0: <\/strong><\/span><span style=\"color: #000000;\">Toutes les donn\u00e9es doivent \u00eatre sauvegard\u00e9es r\u00e9guli\u00e8rement et r\u00e9cup\u00e9rables si n\u00e9cessaire. Les proc\u00e9dures de s\u00e9curit\u00e9 doivent \u00eatre sp\u00e9cifi\u00e9es par \u00e9crit.<\/span><\/p><p><span style=\"color: #000000;\"><strong>7. Support et maintenance du syst\u00e8me : <\/strong><\/span><span style=\"color: #000000;\">Le fabricant du syst\u00e8me ou le service informatique interne est responsable de la maintenance, de la r\u00e9paration et du support technique. Toutes les op\u00e9rations doivent \u00eatre enregistr\u00e9es.<\/span><\/p><p><span style=\"color: #000000;\"><strong>8. Formation et responsabilit\u00e9s : <\/strong><\/span><span style=\"color: #000000;\">Le personnel utilisant le syst\u00e8me doit \u00eatre form\u00e9 en relation avec le BPL et les proc\u00e9dures li\u00e9es au syst\u00e8me. Les responsabilit\u00e9s doivent \u00eatre clairement d\u00e9finies en fonction des r\u00f4les.<\/span><\/p><p><span style=\"color: #000000;\"><strong>9. Exigences relatives \u00e0 la documentation : <\/strong><\/span><span style=\"color: #000000;\">Tous les documents tels que les manuels d'utilisation, les proc\u00e9dures, les rapports de validation et les documents de formation doivent \u00eatre syst\u00e9matiquement archiv\u00e9s.<\/span><\/p><p><span style=\"color: #000000;\"><strong>10. Coop\u00e9ration avec des prestataires de services externes (externalisation) : <\/strong><\/span><span style=\"color: #000000;\">Si les services syst\u00e8me sont achet\u00e9s aupr\u00e8s de tiers (par exemple, les services cloud), leur conformit\u00e9 GLP doit \u00e9galement \u00eatre document\u00e9e et d\u00e9finie de mani\u00e8re contractuelle.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>GLP und digitale Transformation Der Einsatz computergest\u00fctzter Systeme in technologisch gut ausgestatteten, kompetenten Laboren ist unverzichtbar. Da dies mittlerweile Teil der Laborprozesse ist, muss die Sicherheit, Genauigkeit und R\u00fcckverfolgbarkeit elektronischer Daten kontrolliert werden. Dies sind wichtige Punkte im Rahmen der GLP (Gute Laborpraxis), und wir k\u00f6nnen aus dem von der OECD ver\u00f6ffentlichten GLP-Konsensdokument Nr. 10 \u2026 <a href=\"https:\/\/nano-test.de\/fr\/2025\/08\/01\/glp-und-computergestutzte-systeme-uberblick-uber-das-oecd-konsensdokument-nr-10\/\" class=\"more-link\" title=\"Continue reading &lt;span class=\" screen-reader-text>GLP und computergest\u00fctzte Systeme: \u00dcberblick \u00fcber das OECD-Konsensdokument Nr. 10\u00ab\u00a0&gt;Continue reading <span class=\"screen-reader-text\">GLP et syst\u00e8mes informatis\u00e9s : Document de consensus de l'OCDE No. 10 Pr\u00e9sentation<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":3288,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-3286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-glp-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GLP-Anwendung in computergest\u00fctzten Systemen: \u00dcberblick | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Wie sollten die GLP-Grunds\u00e4tze und -Normen auf computergest\u00fctzte Systeme angewandt werden? 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