{"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\/it\/2025\/08\/01\/glp-und-computergestutzte-systeme-uberblick-uber-das-oecd-konsensdokument-nr-10\/","title":{"rendered":"GLP e sistemi computerizzati: Documento di consenso OCSE n. 10 Panoramica"},"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 e trasformazione digitale<\/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'applicazione dei principi GLP ai sistemi informatici include tutti i tipi di sistemi computerizzati utilizzati nelle opere GLP. Questi includono:<\/span><\/p><ul><li><span style=\"color: #000000;\">Sistemi di raccolta e analisi dei dati<\/span><\/li><li><span style=\"color: #000000;\">Sistemi di gestione delle informazioni di laboratorio (LIMS)<\/span><\/li><li><span style=\"color: #000000;\">Software di controllo automatico<\/span><\/li><li><span style=\"color: #000000;\">Sistemi di archiviazione elettronici<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Questi sistemi assistiti da computer devono avere un design appropriato e una capacit\u00e0 sufficiente, aver definito procedure di controllo e manutenzione appropriate e essere stati sviluppati e convalidati in conformit\u00e0 con i principi 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;\">Aspetti da considerare quando si applicano i principi GLP a sistemi computerizzati<\/span><\/h3><p><span style=\"color: #000000;\"><strong>1. Responsabilit\u00e0: <\/strong><\/span><span style=\"color: #000000;\">Al fine di garantire il rispetto dei principi GLP, le responsabilit\u00e0 nel documento sono elencate come segue: responsabilit\u00e0 di gestione, responsabilit\u00e0 del manager del lavoro, responsabilit\u00e0 del personale di laboratorio e responsabilit\u00e0 dell'organismo di garanzia della qualit\u00e0.<\/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\/it\/service\/gute-laborpraxis-glp\/\">GLP-Grunds\u00e4tzen<\/a> zu betreiben.<\/span><\/p><p><span style=\"color: #000000;\">I compiti dell'unit\u00e0 di garanzia della qualit\u00e0 devono essere chiaramente definiti nelle linee guida e nelle procedure scritte. Ci\u00f2 include la convalida del sistema, i processi operativi, le misure di manutenzione e la valutazione dei sistemi acquisiti e sviluppati internamente.<\/span><\/p><p><span style=\"color: #000000;\"><strong>2. Convalida del sistema: <\/strong><\/span><span style=\"color: #000000;\">Ogni sistema computerizzato deve essere convalidato e documentato in base all'uso previsto. La convalida assicura che il sistema funzioni correttamente e in modo coerente.<\/span><\/p><p><strong><span style=\"color: #000000;\">3. Autorizzazione e controllo degli accessi: <\/span><\/strong><span style=\"color: #000000;\">Occorre garantire che solo le persone autorizzate possano accedere al sistema; \u00c8 necessario implementare identit\u00e0 utente, gestione delle password e controlli di accesso basati sui ruoli.<\/span><\/p><p><span style=\"color: #000000;\"><strong>4. Integrit\u00e0 e sicurezza dei dati: <\/strong><\/span><span style=\"color: #000000;\">I dati devono essere indelebili, immutabili e registrati. \u00c8 necessario utilizzare un audit trail, ogni processo deve essere comprensibile.<\/span><\/p><p><span style=\"color: #000000;\"><strong>5. Controllo del cambiamento: <\/strong><\/span><span style=\"color: #000000;\">Eventuali modifiche al sistema devono essere registrate e, se necessario, nuovamente convalidate. Questo vale anche per gli aggiornamenti software.<\/span><\/p><p><span style=\"color: #000000;\"><strong>6. Backup e ripristino del sistema: <\/strong><\/span><span style=\"color: #000000;\">Tutti i dati devono essere sottoposti a backup regolarmente e recuperabili, se necessario. Le procedure di sicurezza devono essere specificate per iscritto.<\/span><\/p><p><span style=\"color: #000000;\"><strong>7. Supporto e manutenzione del sistema: <\/strong><\/span><span style=\"color: #000000;\">Il produttore del sistema o il reparto IT interno \u00e8 responsabile della manutenzione, riparazione e supporto tecnico. Tutte le operazioni devono essere registrate.<\/span><\/p><p><span style=\"color: #000000;\"><strong>8. Formazione e responsabilit\u00e0: <\/strong><\/span><span style=\"color: #000000;\">Il personale che utilizza il sistema deve essere formato in relazione al GLP e alle procedure relative al sistema. Le responsabilit\u00e0 devono essere chiaramente definite in base ai ruoli.<\/span><\/p><p><span style=\"color: #000000;\"><strong>9. Requisiti di documentazione: <\/strong><\/span><span style=\"color: #000000;\">Tutti i documenti come manuali utente, procedure, rapporti di convalida e documenti di formazione devono essere archiviati sistematicamente.<\/span><\/p><p><span style=\"color: #000000;\"><strong>10. Cooperazione con fornitori di servizi esterni (outsourcing): <\/strong><\/span><span style=\"color: #000000;\">Se i servizi di sistema vengono acquistati da terze parti (ad es. servizi cloud), la loro conformit\u00e0 GLP deve anche essere documentata e definita contrattualmente.<\/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\/it\/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\u201c&gt;Continue reading <span class=\"screen-reader-text\">GLP e sistemi computerizzati: Documento di consenso OCSE n. 10 Panoramica<\/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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