{"id":8506,"date":"2025-07-23T13:48:39","date_gmt":"2025-07-23T05:48:39","guid":{"rendered":"https:\/\/regask.com\/?p=8506"},"modified":"2025-07-23T13:50:16","modified_gmt":"2025-07-23T05:50:16","slug":"actualizacion-de-la-documentacion-de-los-sistemas-informaticos-de-ia-directrices-gmp-de-la-ue-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","title":{"rendered":"La Comisi\u00f3n Europea lanza una consulta p\u00fablica sobre la actualizaci\u00f3n..."},"content":{"rendered":"<p>En <strong>7 de julio de 2025<\/strong>, el <a href=\"https:\/\/commission.europa.eu\/about\/departments-and-executive-agencies\/health-and-food-safety_en\"><strong>Direcci\u00f3n General de Salud y Seguridad Alimentaria de la Comisi\u00f3n Europea<\/strong><\/a> abri\u00f3 una <strong>consulta p\u00fablica<\/strong> sobre las revisiones propuestas a <strong>EudraLex Volumen 4 \u2013 Directrices de buenas pr\u00e1cticas de fabricaci\u00f3n (BPF)<\/strong>Las actualizaciones se aplican a:<\/p>\n<ul>\n<li><strong>Cap\u00edtulo 4: Documentaci\u00f3n<\/strong><\/li>\n<li><strong>Anexo 11: Sistemas informatizados<\/strong><\/li>\n<li><strong>Anexo 22: Inteligencia Artificial<\/strong> <em>(reci\u00e9n introducido)<\/em><\/li>\n<\/ul>\n<p>Estos cambios propuestos tienen como objetivo <strong>modernizar las pr\u00e1cticas GMP<\/strong> mediante el fortalecimiento <strong>integridad de los datos<\/strong>, integrando <strong>Gobernanza de la IA<\/strong>, y mejorar la supervisi\u00f3n de <strong>sistemas informatizados<\/strong> y <strong>documentaci\u00f3n<\/strong> en <strong>fabricaci\u00f3n farmac\u00e9utica<\/strong>.<\/p>\n<p><strong>Aspectos destacados:<\/strong><\/p>\n<ul>\n<li>El <strong>Cap\u00edtulo 4 actualizado<\/strong> enfatiza <strong>pr\u00e1cticas de documentaci\u00f3n basadas en riesgos<\/strong>, junto con una mejor gesti\u00f3n de <strong>registros electr\u00f3nicos<\/strong> y <strong>firmas<\/strong>, garantizando al mismo tiempo la <strong>legibilidad e integridad<\/strong> de documentaci\u00f3n en todos los formatos.<\/li>\n<li>El <strong>Anexo 11 revisado<\/strong> refuerza la aplicaci\u00f3n de <strong>Gesti\u00f3n de riesgos de calidad (QRM)<\/strong> A lo largo del ciclo de vida de <strong>sistemas informatizados<\/strong>, introduciendo controles m\u00e1s estrictos para <strong>juicios de auditor\u00eda<\/strong>, <strong>seguridad del sistema<\/strong>, y <strong>supervisi\u00f3n de proveedores<\/strong>.<\/li>\n<li>El <strong>Anexo 22 recientemente introducido<\/strong> Establece un marco regulatorio claro para el uso de <strong>Inteligencia Artificial en entornos GMP<\/strong>, abordando los requisitos relacionados con <strong>validaci\u00f3n del modelo<\/strong>, <strong>calidad de los datos de entrenamiento<\/strong>, <strong>m\u00e9tricas de rendimiento<\/strong>, y <strong>supervisi\u00f3n humana continua<\/strong>.<\/li>\n<\/ul>\n<h4><strong>Fecha l\u00edmite para enviar comentarios: 7 de octubre de 2025<\/strong><\/h4>\n\t<div id=\"gap-2139785941\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2139785941 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Por qu\u00e9 es importante:<\/strong><br \/>Se espera que estas revisiones:<\/p>\n<ul>\n<li>Mejorar <strong>claridad regulatoria<\/strong><\/li>\n<li>Alinearse con <strong>tecnolog\u00edas digitales emergentes<\/strong><\/li>\n<li>Promover <strong>eficiencia operativa<\/strong><\/li>\n<li>Introducir <strong>nuevas cargas m\u00ednimas de cumplimiento<\/strong><\/li>\n<\/ul>\n<p><strong>Las aportaciones de las partes interesadas desempe\u00f1ar\u00e1n un papel decisivo a la hora de elaborar una orientaci\u00f3n que sea pr\u00e1ctica y est\u00e9 alineada con los avances tecnol\u00f3gicos.<\/strong> Estas actualizaciones son especialmente relevantes para los profesionales en <strong>Calidad, Asuntos Regulatorios, Cumplimiento de TI e Implementaci\u00f3n de IA en GMP-<\/strong>entornos regulados.<\/p>\n<p><strong>Pr\u00f3ximos pasos<\/strong><br \/>Las partes interesadas deben revisar los borradores de las revisiones del Cap\u00edtulo 4, Anexo 11 y Anexo 22, evaluar el impacto interno y coordinar la retroalimentaci\u00f3n interfuncional. Los comentarios deben enviarse a trav\u00e9s de <a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\">Portal de la Comisi\u00f3n Europea por <strong>7 de octubre de 2025<\/strong>.<\/a><\/p>\n<p><strong>C\u00f3mo ayuda RegASK<\/strong><br \/>RegASK es una plataforma impulsada por IA que monitorea continuamente las actualizaciones regulatorias, incluidas las pautas de GMP e IA, para ayudar a los equipos de ciencias biol\u00f3gicas a mantenerse preparados y en cumplimiento.<br \/><a href=\"https:\/\/regask.com\/es\/\"><strong>M\u00e1s informaci\u00f3n<\/strong><\/a><strong> o <\/strong><a href=\"https:\/\/regask.com\/es\/reservar-una-demostracion\/\"><strong>Reservar una demostraci\u00f3n<\/strong><\/a><\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:1em;margin-bottom:1em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n\t<div id=\"gap-791302047\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-791302047 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>Preguntas frecuentes<\/strong><\/h4>\n\t<div id=\"gap-682074802\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-682074802 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ol>\n<li><strong> \u00bfQu\u00e9 es el Anexo 22 de las directrices BPF actualizadas de la UE?<\/strong><br \/>\nEl Anexo 22 es una secci\u00f3n recientemente propuesta en el Volumen 4 de EudraLex. Establece los requisitos reglamentarios para el uso de la inteligencia artificial en la fabricaci\u00f3n de productos farmac\u00e9uticos, incluida la validaci\u00f3n de modelos, los est\u00e1ndares de datos de entrenamiento y la supervisi\u00f3n humana.<\/li>\n<li><strong> \u00bfQu\u00e9 cambios se est\u00e1n realizando en los sistemas informatizados seg\u00fan el Anexo 11?<\/strong><br \/>\nEl Anexo 11 actualizado introduce pr\u00e1cticas m\u00e1s estrictas de Gesti\u00f3n de Riesgos de Calidad para sistemas inform\u00e1ticos. Se centra en las auditor\u00edas, las firmas electr\u00f3nicas, la seguridad del sistema y la supervisi\u00f3n de proveedores.<\/li>\n<li><strong> \u00bfCu\u00e1les son los requisitos de documentaci\u00f3n en el Cap\u00edtulo 4 revisado de las BPM de la UE?<\/strong><br \/>\nEl Cap\u00edtulo 4 revisado enfatiza la integridad de los datos, la gobernanza basada en riesgos y la gesti\u00f3n adecuada de la documentaci\u00f3n en todos los formatos. Tambi\u00e9n refuerza los requisitos para la gesti\u00f3n de registros y firmas electr\u00f3nicas.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>On July 7, 2025, the European Commission\u2019s Directorate-General for Health and Food Safety opened a public consultation on proposed revisions to EudraLex Volume 4 \u2013 Good Manufacturing Practice (GMP) Guidelines. The updates apply to: Chapter 4: Documentation Annex 11: Computerized Systems Annex 22: Artificial Intelligence (newly introduced) These proposed changes aim to modernize GMP practices&#8230;<\/p>","protected":false},"author":32,"featured_media":8508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33],"tags":[],"class_list":["post-8506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>European Commission Launches GMP Consultation | RegASK<\/title>\n<meta name=\"description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. 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