{"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\/es\/2025\/08\/01\/glp-und-computergestutzte-systeme-uberblick-uber-das-oecd-konsensdokument-nr-10\/","title":{"rendered":"GLP y sistemas computarizados: Documento de Consenso de la OCDE No. 10"},"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 y transformaci\u00f3n digital<\/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;\">La aplicaci\u00f3n de los Principios GLP a los sistemas inform\u00e1ticos incluye todo tipo de sistemas computarizados utilizados en los trabajos de GLP. Estos incluyen:<\/span><\/p><ul><li><span style=\"color: #000000;\">Sistemas de recopilaci\u00f3n y an\u00e1lisis de datos<\/span><\/li><li><span style=\"color: #000000;\">Sistemas de gesti\u00f3n de informaci\u00f3n de laboratorio (LIMS)<\/span><\/li><li><span style=\"color: #000000;\">Software de control autom\u00e1tico<\/span><\/li><li><span style=\"color: #000000;\">Sistemas de archivo electr\u00f3nico<\/span><\/li><\/ul><p><span style=\"color: #000000;\">Estos sistemas asistidos por computadora deben tener un dise\u00f1o adecuado y suficiente capacidad, han definido procedimientos de control y mantenimiento apropiados y han sido desarrollados y validados de acuerdo con los principios de 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;\">Aspectos a tener en cuenta al aplicar principios GLP a sistemas computarizados<\/span><\/h3><p><span style=\"color: #000000;\"><strong>1. Responsabilidades: <\/strong><\/span><span style=\"color: #000000;\">Para garantizar el cumplimiento de los principios de GLP, las responsabilidades en el documento se enumeran de la siguiente manera: Responsabilidades de gesti\u00f3n, Responsabilidades de Gerente Laboral, Responsabilidades del personal de laboratorio y Responsabilidades del cuerpo de aseguramiento de la calidad.<\/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\/es\/service\/gute-laborpraxis-glp\/\">GLP-Grunds\u00e4tzen<\/a> zu betreiben.<\/span><\/p><p><span style=\"color: #000000;\">Las tareas de la Unidad de Garant\u00eda de Calidad deben estar claramente definidas en las directrices y procedimientos escritos. Esto incluye la validaci\u00f3n del sistema, los procesos operativos, las medidas de mantenimiento y la evaluaci\u00f3n de sistemas adquiridos y desarrollados internamente.<\/span><\/p><p><span style=\"color: #000000;\"><strong>2. Validaci\u00f3n del sistema: <\/strong><\/span><span style=\"color: #000000;\">Cada sistema asistido por computadora debe ser validado y documentado de acuerdo con su uso previsto. La validaci\u00f3n garantiza que el sistema funcione de manera correcta y consistente.<\/span><\/p><p><strong><span style=\"color: #000000;\">3. Autorizaci\u00f3n y control de acceso: <\/span><\/strong><span style=\"color: #000000;\">Debe garantizarse que s\u00f3lo las personas autorizadas puedan acceder al sistema; Se deben implementar las identidades de los usuarios, la administraci\u00f3n de contrase\u00f1as y los controles de acceso basados en roles.<\/span><\/p><p><span style=\"color: #000000;\"><strong>4. Integridad y seguridad de los datos: <\/strong><\/span><span style=\"color: #000000;\">Los datos deben ser indelebles, inmutables y registrados. Se debe utilizar una pista de auditor\u00eda, cada proceso debe ser comprensible.<\/span><\/p><p><span style=\"color: #000000;\"><strong>5. Control de cambios: <\/strong><\/span><span style=\"color: #000000;\">Cualquier cambio en el sistema debe ser registrado y, si es necesario, validarse nuevamente. Esto tambi\u00e9n se aplica a las actualizaciones de software.<\/span><\/p><p><span style=\"color: #000000;\"><strong>6. Copia de seguridad y recuperaci\u00f3n del sistema: <\/strong><\/span><span style=\"color: #000000;\">Todos los datos deben ser respaldados regularmente y recuperables si es necesario. Los procedimientos de seguridad deben especificarse por escrito.<\/span><\/p><p><span style=\"color: #000000;\"><strong>7. Soporte y mantenimiento del sistema: <\/strong><\/span><span style=\"color: #000000;\">El fabricante del sistema o el departamento de TI interno es responsable del mantenimiento, reparaci\u00f3n y soporte t\u00e9cnico. Todas las operaciones deben ser registradas.<\/span><\/p><p><span style=\"color: #000000;\"><strong>8. Formaci\u00f3n y Responsabilidades: <\/strong><\/span><span style=\"color: #000000;\">El personal que utilice el sistema debe estar capacitado en relaci\u00f3n con GLP y los procedimientos relacionados con el sistema. Las responsabilidades deben estar claramente definidas de acuerdo con los roles.<\/span><\/p><p><span style=\"color: #000000;\"><strong>9. Requisitos de documentaci\u00f3n: <\/strong><\/span><span style=\"color: #000000;\">Todos los documentos, como manuales de usuario, procedimientos, informes de validaci\u00f3n y documentos de capacitaci\u00f3n, deben archivarse sistem\u00e1ticamente.<\/span><\/p><p><span style=\"color: #000000;\"><strong>10. Cooperaci\u00f3n con proveedores de servicios externos (outsourcing): <\/strong><\/span><span style=\"color: #000000;\">Si los servicios del sistema se compran a terceros (por ejemplo, servicios en la nube), su cumplimiento de GLP tambi\u00e9n debe documentarse y definirse contractualmente.<\/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\/es\/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&gt;Continue reading <span class=\"screen-reader-text\">GLP y sistemas computarizados: Documento de Consenso de la OCDE No. 10<\/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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