{"id":11021,"date":"2026-06-16T08:00:35","date_gmt":"2026-06-16T06:00:35","guid":{"rendered":"http:\/\/localhost\/fast-furious-ebr-implementation\/"},"modified":"2026-09-18T08:34:29","modified_gmt":"2026-09-18T06:34:29","slug":"fast-furious-ebr-implementation","status":"publish","type":"post","link":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/","title":{"rendered":"Fast &#038; Furious eBR Implementation"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;2px|||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Montserrat||||||||&#8221; header_font=&#8221;Montserrat||||||||&#8221; header_text_align=&#8221;justify&#8221; header_font_size=&#8221;14px&#8221; text_orientation=&#8221;justified&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>SIM, \u00e9 verdade, \u00e9 poss\u00edvel uma <strong>Fast &#038; Furious eBR Implementation<\/strong>. J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do <a href=\"https:\/\/www.oytec.es\/pt\/registo-de-lote-eletronico-ebr\/\" target=\"_blank\" rel=\"noopener\">Electronic Batch Record<\/a> de forma r\u00e1pida e massiva em qualquer f\u00e1brica. N\u00e3o importa a \u00e1rea de fabrico: bulk, pesagens ou acondicionamento. N\u00e3o importa a tipologia do processo de fabrico: formas s\u00f3lidas, gelatinas, cremes, pellets, injet\u00e1veis, processos biol\u00f3gicos, fabrico de APIs\u2026 todos podem ser digitalizados de forma r\u00e1pida e massiva.<\/p>\n<p><strong>Surgiu uma f\u00f3rmula milagrosa? Uma tecnologia disruptiva?<\/strong><br \/>N\u00e3o, basta aproveitar as novas tecnologias para definir uma nova abordagem, uma forma diferente de encarar a estrat\u00e9gia de implementa\u00e7\u00e3o do eBR.<\/p>\n<p><strong>\u00c9 necess\u00e1rio que o meu objetivo a longo prazo, de ter um eBR completo com todas as funcionalidades, mude? <\/strong><br \/>N\u00e3o, basta adaptar a minha estrat\u00e9gia, o meu roadmap de implementa\u00e7\u00e3o, podendo chegar ao mesmo objetivo de forma mais faseada.<\/p>\n<p>Na <a href=\"https:\/\/oytec.es\" target=\"_blank\" rel=\"noopener\">OYTEC<\/a> sempre encar\u00e1mos e sempre encararemos a implementa\u00e7\u00e3o do eBR como um processo de <strong>Transforma\u00e7\u00e3o Digital<\/strong>, uma oportunidade \u00fanica para melhorar os processos, otimizar as opera\u00e7\u00f5es, aumentar a qualidade e assegurar o compliance. Mas sempre o fizemos a partir de uma an\u00e1lise exaustiva dos processos, da procura e normaliza\u00e7\u00e3o de opera\u00e7\u00f5es comuns (bibliotecas de opera\u00e7\u00f5es), bem como da cria\u00e7\u00e3o de registos de lote eletr\u00f3nicos multiproduto. <strong>Eliminando 100% do papel<\/strong> e otimizando ao m\u00e1ximo todos os processos de revis\u00e3o para conseguir uma <strong>Revis\u00e3o por Exce\u00e7\u00e3o em tempo real, plena e completa.<\/strong> Esta abordagem permite-nos tamb\u00e9m otimizar a cria\u00e7\u00e3o de receitas futuras, bem como a altera\u00e7\u00e3o dos Batch Records existentes (propaga\u00e7\u00e3o de altera\u00e7\u00f5es).<\/p>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/oytec.es\/wp-content\/uploads\/Siemens-SIMATIC.png&#8221; title_text=&#8221;Siemens SIMATIC&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;45%&#8221; module_alignment=&#8221;center&#8221; box_shadow_style=&#8221;preset2&#8243; box_shadow_horizontal=&#8221;4px&#8221; box_shadow_vertical=&#8221;4px&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_text ol_item_indent=&#8221;40px&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Montserrat||||||||&#8221; ul_font=&#8221;Montserrat||||||||&#8221; ol_font=&#8221;Montserrat|&#8211;et_global_body_font_weight|||||||&#8221; ol_text_align=&#8221;justify&#8221; ol_line_height=&#8221;2em&#8221; header_2_font=&#8221;Montserrat||||||||&#8221; header_2_text_align=&#8221;justify&#8221; text_orientation=&#8221;justified&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Esta abordagem, digamos \u201cmais tradicional\u201d, implica uma an\u00e1lise profunda de todos os processos e partir, desde o primeiro dia, de uma estrat\u00e9gia de implementa\u00e7\u00e3o completa ou quase completa das funcionalidades que devemos esperar de um eBR: gest\u00e3o de materiais, equipamentos, limpezas, integra\u00e7\u00e3o completa com os sistemas sat\u00e9lite ou de automa\u00e7\u00e3o, IPC, eLogbook, entre outras. Esta abordagem <strong>100% transformadora desde o primeiro dia<\/strong> implica muita dedica\u00e7\u00e3o na an\u00e1lise inicial de cada um dos processos, atrasando a obten\u00e7\u00e3o dos primeiros resultados. Os resultados n\u00e3o s\u00e3o r\u00e1pidos e o ROI chega mais tarde.<\/p>\n<p>Esta nova abordagem, a que chamamos <strong>&#8220;Fast &#038; Furious eBR Implementation&#8221;<\/strong>, permite-nos chegar ao mesmo objetivo, FULL eBR, mas com uma estrat\u00e9gia de implementa\u00e7\u00e3o diferente.<\/p>\n<\/p>\n<ol>\n<li>Migra\u00e7\u00e3o massiva dos MBR para eBR utilizando a IA como ferramenta de convers\u00e3o autom\u00e1tica, a que chamaremos <strong>AI Smart Designer<\/strong>. Al\u00e9m disso, com a possibilidade de os pr\u00f3prios editores de guias do cliente treinarem os modelos de convers\u00e3o autom\u00e1tica. Podendo, inclusivamente, treinar diferentes modelos, um para cada \u00e1rea de fabrico, por exemplo: s\u00f3lidos, injet\u00e1veis, l\u00edquidos, pellets, entre outros. Tudo isto suportado por um <strong>Knowledge Assistant Copilot<\/strong> para a edi\u00e7\u00e3o de guias em linguagem natural, treinado com toda a informa\u00e7\u00e3o do projeto eBR\/MES, acelerando ainda mais o processo de cria\u00e7\u00e3o de eBR. Em suma, <strong>com a IA poderemos treinar modelos para cada \u00e1rea de processo, podendo chegar a n\u00edveis de convers\u00e3o direta superiores a 80%.<br \/>\u00a0<\/strong><\/li>\n<li>Digitalizamos de forma r\u00e1pida e massiva os Batch Records Eletr\u00f3nicos, sacrificando funcionalidades e com uma abordagem inicial menos transformadora. Mas<strong> a obten\u00e7\u00e3o dos primeiros resultados \u00e9 muito mais r\u00e1pida, o ROI come\u00e7a a surgir muito mais cedo <\/strong>e temos uma primeira camada de digitaliza\u00e7\u00e3o em toda a f\u00e1brica <strong>a partir dos 3 primeiros meses.<br \/>\u00a0<\/strong><\/li>\n<li>Numa segunda fase, de forma gradual, j\u00e1 podemos pensar em acrescentar novas funcionalidades ou melhorar as existentes com estrat\u00e9gias muito mais transformadoras, com o objetivo de <strong>obter 100% dos benef\u00edcios esperados.<\/strong> Definir bibliotecas de opera\u00e7\u00f5es padr\u00e3o e conceber registos eletr\u00f3nicos multiproduto, utilizando a pot\u00eancia do Knowledge Assistant Copilot.<\/li>\n<\/ol>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/oytec.es\/wp-content\/uploads\/FF_3_c-1.png&#8221; title_text=&#8221;F&#038;F_3_c&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;45%&#8221; module_alignment=&#8221;center&#8221; box_shadow_style=&#8221;preset2&#8243; box_shadow_horizontal=&#8221;4px&#8221; box_shadow_vertical=&#8221;4px&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_gallery gallery_ids=&#8221;10860&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; width=&#8221;40%&#8221; max_width=&#8221;100%&#8221; module_alignment=&#8221;center&#8221; box_shadow_style=&#8221;preset2&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_gallery][et_pb_text ol_item_indent=&#8221;40px&#8221; _builder_version=&#8221;4.27.6&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Montserrat||||||||solid&#8221; ul_font=&#8221;Montserrat||||||||&#8221; ol_font=&#8221;Montserrat|&#8211;et_global_body_font_weight|||||||&#8221; ol_text_align=&#8221;justify&#8221; ol_line_height=&#8221;2em&#8221; header_2_font=&#8221;Montserrat||||||||&#8221; header_2_text_align=&#8221;justify&#8221; text_orientation=&#8221;justified&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Diferentes caminhos que convergem num processo de Transforma\u00e7\u00e3o Digital em que o ROI, mais cedo ou mais tarde, surge sob a forma de benef\u00edcios extremamente tang\u00edveis:<\/p>\n<ul>\n<li><strong>Redu\u00e7\u00e3o do tempo de revis\u00e3o dos Batch Records superior a 75%<\/strong><\/li>\n<li><strong>Redu\u00e7\u00e3o dos desvios nos Batch Records na ordem dos 98%<\/strong><\/li>\n<li><strong>Redu\u00e7\u00e3o dos tempos de introdu\u00e7\u00e3o de dados superior a 75%<\/strong><\/li>\n<li><strong>Right First Time superior a 95%<br \/><\/strong><\/li>\n<\/ul>\n<p>Quer saber como aplicar esta metodologia na sua f\u00e1brica? <strong><a href=\"mailto:info@oytec.es?subject=Fast%20%26%20Furious%20eBR%20Implementation%20%E2%80%93%20Hablemos&amp;body=Hola%2C%0A%0AQuiero%20digitalizar%20mi%20planta%20a%20toda%20velocidad.%20Cu\u00e9ntame%20m\u00e1s%20sobre%20%20Fast%20%26%20Furious%20eBR%20Implementation.%0A%0AListo%20para%20pisar%20el%20acelerador.\" target=\"_blank\" rel=\"noopener\">Podemos explicar-lhe.<\/a><\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text disabled_on=&#8221;on|on|on&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Montserrat||||||||&#8221; header_font=&#8221;Montserrat||||||||&#8221; header_2_font=&#8221;Montserrat||||||||&#8221; header_2_text_align=&#8221;justify&#8221; text_orientation=&#8221;justified&#8221; disabled=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2><strong>Como a OYTEC implementa a IA<\/strong><\/h2>\n<p>A OYTEC implementa <strong>solu\u00e7\u00f5es de IA em ambientes GxP juntamente com parceiros tecnol\u00f3gicos como a Siemens e a Aizon<\/strong>, alinhando planos e relat\u00f3rios de credibilidade com o cumprimento GMP. Para mais informa\u00e7\u00f5es, pode <a href=\"https:\/\/www.oytec.es\/pt\/contacto\/\">contactar os nossos especialistas.<\/a> [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;9px|||||&#8221; z_index_tablet=&#8221;500&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row module_class=&#8221; et_pb_row_fullwidth&#8221; _builder_version=&#8221;4.16&#8243; width=&#8221;89%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;&#8221; width_last_edited=&#8221;on|desktop&#8221; max_width=&#8221;89%&#8221; max_width_tablet=&#8221;80%&#8221; max_width_phone=&#8221;&#8221; max_width_last_edited=&#8221;on|desktop&#8221; custom_padding=&#8221;11px|0px|38.0469px|0px|false|false&#8221; z_index_tablet=&#8221;500&#8243; make_fullwidth=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_divider _builder_version=&#8221;4.16&#8243; z_index_tablet=&#8221;500&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][et_pb_text _builder_version=&#8221;4.27.6&#8243; text_font=&#8221;Roboto||||||||&#8221; text_text_color=&#8221;#000000&#8243; z_index_tablet=&#8221;500&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h3><strong style=\"color: #333333; font-size: 22px;\"><strong>\u00daltimas Not\u00edcias <\/strong><\/strong><\/h3>\n<p>[\/et_pb_text][et_pb_blog fullwidth=&#8221;off&#8221; posts_number=&#8221;3&#8243; include_categories=&#8221;3,5,17,7&#8243; show_more=&#8221;on&#8221; show_date=&#8221;off&#8221; _builder_version=&#8221;4.16&#8243; z_index_tablet=&#8221;500&#8243; box_shadow_style=&#8221;preset3&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_blog][et_pb_button button_url=&#8221;https:\/\/oytec.es\/blog-oytec\/&#8221; button_text=&#8221;Mais not\u00edcias&#8221; button_alignment=&#8221;center&#8221; _builder_version=&#8221;4.16&#8243; z_index_tablet=&#8221;500&#8243; global_colors_info=&#8221;{}&#8221;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#eef1f7&#8243; background_image=&#8221;https:\/\/www.oytec.es\/wp-content\/uploads\/2021\/03\/Footer_Oytec_400.jpg&#8221; background_enable_image=&#8221;off&#8221; custom_margin=&#8221;||-55px|||&#8221; custom_padding=&#8221;3px||3px|||&#8221; saved_tabs=&#8221;all&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_5,1_5,1_5,1_5,1_5&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; module_alignment=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_5&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-9px||20px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<strong>BARCELONA<\/strong>[\/et_pb_text][et_pb_text admin_label=&#8221;Texto&#8221; _builder_version=&#8221;4.16&#8243; text_font=&#8221;Roboto||||||||&#8221; text_text_color=&#8221;#636363&#8243; header_3_font=&#8221;|||on|||||&#8221; header_6_text_color=&#8221;#7c7c7c&#8221; background_layout=&#8221;dark&#8221; custom_padding=&#8221;0px|||||&#8221; z_index_tablet=&#8221;500&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<aside>@SANTCUGAT building<\/aside>\n<aside>Av. Via Augusta, 15-25<\/aside>\n<aside>08174 Sant Cugat del Vall\u00e8s<\/aside>\n<aside>Barcelona, ES<\/aside>\n<aside>+34 610 459 081<\/aside>\n<aside>\n<div>\n<div>info@oytec.es<\/div>\n<\/div>\n<\/aside>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_5&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-9px||20px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<strong>MADRID<\/strong>[\/et_pb_text][et_pb_text admin_label=&#8221;Texto&#8221; _builder_version=&#8221;4.16&#8243; text_font=&#8221;Roboto||||||||&#8221; text_text_color=&#8221;#636363&#8243; header_3_font=&#8221;|||on|||||&#8221; header_6_text_color=&#8221;#7c7c7c&#8221; background_layout=&#8221;dark&#8221; custom_padding=&#8221;0px|||||&#8221; z_index_tablet=&#8221;500&#8243; global_colors_info=&#8221;{}&#8221;]Carretera M-603 Fuencarral a Alcobendas Portal n\u00ba 44, Edificio 6, Piso Bajo, Puerta 23 28108, Alcobendas, Madrid[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_5&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/oytec.es\/wp-content\/uploads\/2023\/06\/CertificadoER-0524-2021_ES_2021-10-19-1.jpg&#8221; title_text=&#8221;CertificadoER-0524-2021_ES_2021-10-19-1&#8243; show_in_lightbox=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; max_width=&#8221;50%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_5&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_image src=&#8221;https:\/\/oytec.es\/wp-content\/uploads\/2023\/06\/IQNetES-0524-2021_2021-10-19-1.jpg&#8221; title_text=&#8221;IQNetES-0524-2021_2021-10-19-1&#8243; show_in_lightbox=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; width=&#8221;50%&#8221; max_width=&#8221;50%&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_5&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;RGBA(255,255,255,0)&#8221; custom_margin=&#8221;-6px|||||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: right;\"><span style=\"color: #808080;\"><a style=\"color: #808080;\" href=\"https:\/\/www.oytec.es\/pt\/contacto\/\">CONTACT<\/a><\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"color: #808080;\"><a style=\"color: #808080;\" href=\"https:\/\/www.oytec.es\/pt\/blog\/\">BLOG<\/a><\/span><\/p>\n<p style=\"text-align: right;\"><a href=\"https:\/\/www.oytec.es\/pt\/legal\/\"><span style=\"color: #808080;\">LEGAL<\/span><\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>SIM, \u00e9 verdade, \u00e9 poss\u00edvel uma Fast &#038; Furious eBR Implementation. J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica. N\u00e3o importa a \u00e1rea de fabrico: bulk, pesagens ou acondicionamento. N\u00e3o importa a tipologia do processo de fabrico: formas s\u00f3lidas, gelatinas, cremes, pellets, injet\u00e1veis, [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":10900,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<p><a style=\"font-size: 14px;\" href=\"https:\/\/oytec.es\/wp-content\/uploads\/Revista-Farmabiotec-Numero-18-66-71.pdf\"><img class=\"wp-image-10242 aligncenter\" src=\"https:\/\/oytec.es\/wp-content\/uploads\/Captura-revista-Guillem-800x561.png\" alt=\"\" width=\"445\" height=\"312\" \/><\/a>La FDA sit\u00faa la credibilidad como condici\u00f3n indispensable para utilizar IA en decisiones regulatorias farmac\u00e9uticas, en un marco proporcional al riesgo que exige trazabilidad, transparencia y validaci\u00f3n a lo largo de todo el ciclo de vida del modelo. Este enfoque ha sido sintetizado y divulgado por Guillem L\u00f3pez, CSV & QA Manager de OYTEC, autor del an\u00e1lisis publicado en el n\u00famero 18 de la revista FARMABIOTEC.<\/p><h2>Exigencias regulatorias<\/h2><p>El borrador emitido en enero de 2025 define que el rigor de la evaluaci\u00f3n debe ajustarse a la influencia del modelo en la decisi\u00f3n y a la severidad de sus consecuencias, articulando un plan de credibilidad y un reporte final que demuestre idoneidad para el contexto de uso. Entre los elementos clave se incluyen la definici\u00f3n de la pregunta de inter\u00e9s, el contexto de uso, la estratificaci\u00f3n de riesgo, la descripci\u00f3n t\u00e9cnica del modelo y datos, la validaci\u00f3n con m\u00e9tricas justificadas y la planificaci\u00f3n de mantenimiento y monitorizaci\u00f3n del desempe\u00f1o.<\/p><h2>Aportaci\u00f3n de OYTEC y su autor<\/h2><p>Desde OYTEC, Guillem L\u00f3pez destaca la necesidad de un <em>Credibility Assessment Plan<\/em> y un <em>Credibility Assessment Report<\/em> que conecten evidencia t\u00e9cnica con la toma de decisiones reguladas, integrando GxP y marcos como GAMP5 Ed.2 e ISPE para asegurar reproducibilidad y control del cambio.<\/p><h2>OYTEC y la IA, los partners<\/h2><p>OYTEC implementa soluciones de IA en entornos GxP junto a partners tecnol\u00f3gicos como Aizon, alineando planes y reportes de credibilidad con el marco FDA para asegurar trazabilidad, detecci\u00f3n de sesgos y vigilancia de drift post\u2011despliegue.<\/p><p>Para profundizar, puede consultar el art\u00edculo de Guillem L\u00f3pez en FARMABIOTEC (n\u00ba18, p\u00e1gs. 66\u201371)<a href=\"https:\/\/oytec.es\/wp-content\/uploads\/Revista-Farmabiotec-Numero-18-66-71.pdf\" target=\"_blank\" rel=\"noopener\"> Revista Farmabiotec - N\u00famero 18-66-71<\/a><\/p>","_et_gb_content_width":"","_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[209,213,211,210],"tags":[215,220,219,216],"class_list":["post-11021","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digitalizacao","category-gmp","category-ia","category-transformacao-digital","tag-215","tag-ebr","tag-gmp","tag-ia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Fast &amp; Furious eBR Implementation - OYTEC<\/title>\n<meta name=\"description\" content=\"J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fast &amp; Furious eBR Implementation - OYTEC\" \/>\n<meta property=\"og:description\" content=\"J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/\" \/>\n<meta property=\"og:site_name\" content=\"OYTEC\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-16T06:00:35+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-18T06:34:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.oytec.es\/wp-content\/uploads\/FF-eBR_destacada-Blog_OYTEC-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2100\" \/>\n\t<meta property=\"og:image:height\" content=\"748\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fernando L\u00f3pez\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@OYTEC_MES\" \/>\n<meta name=\"twitter:site\" content=\"@OYTEC_MES\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fernando L\u00f3pez\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tempo estimado de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/\"},\"author\":{\"name\":\"Fernando L\u00f3pez\",\"@id\":\"https:\\\/\\\/oytec.es\\\/#\\\/schema\\\/person\\\/84c11328cbacd3aab5590e508267a09b\"},\"headline\":\"Fast &#038; Furious eBR Implementation\",\"datePublished\":\"2026-06-16T06:00:35+00:00\",\"dateModified\":\"2026-09-18T06:34:29+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/\"},\"wordCount\":1696,\"publisher\":{\"@id\":\"https:\\\/\\\/oytec.es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.oytec.es\\\/wp-content\\\/uploads\\\/FF-eBR_destacada-Blog_OYTEC-1.jpg\",\"keywords\":[\"2026\",\"eBR\",\"GMP\",\"IA\"],\"articleSection\":[\"Digitaliza\u00e7\u00e3o\",\"GMP\",\"IA\",\"Transforma\u00e7\u00e3o Digital\"],\"inLanguage\":\"pt-PT\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/\",\"url\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/\",\"name\":\"Fast & Furious eBR Implementation - OYTEC\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/oytec.es\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.oytec.es\\\/wp-content\\\/uploads\\\/FF-eBR_destacada-Blog_OYTEC-1.jpg\",\"datePublished\":\"2026-06-16T06:00:35+00:00\",\"dateModified\":\"2026-09-18T06:34:29+00:00\",\"description\":\"J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#breadcrumb\"},\"inLanguage\":\"pt-PT\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-PT\",\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.oytec.es\\\/wp-content\\\/uploads\\\/FF-eBR_destacada-Blog_OYTEC-1.jpg\",\"contentUrl\":\"https:\\\/\\\/www.oytec.es\\\/wp-content\\\/uploads\\\/FF-eBR_destacada-Blog_OYTEC-1.jpg\",\"width\":2100,\"height\":748},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/fast-furious-ebr-implementation\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\\\/\\\/www.oytec.es\\\/pt\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Fast &#038; Furious eBR Implementation\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/oytec.es\\\/#website\",\"url\":\"https:\\\/\\\/oytec.es\\\/\",\"name\":\"OYTEC\",\"description\":\"Digitalizando las operaciones Farma 4.0\",\"publisher\":{\"@id\":\"https:\\\/\\\/oytec.es\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/oytec.es\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"pt-PT\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/oytec.es\\\/#organization\",\"name\":\"OYTEC\",\"url\":\"https:\\\/\\\/oytec.es\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-PT\",\"@id\":\"https:\\\/\\\/oytec.es\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/oytec.es\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/cropped-OYTEC-Logo-transparent.png\",\"contentUrl\":\"https:\\\/\\\/oytec.es\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/cropped-OYTEC-Logo-transparent.png\",\"width\":175,\"height\":45,\"caption\":\"OYTEC\"},\"image\":{\"@id\":\"https:\\\/\\\/oytec.es\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/x.com\\\/OYTEC_MES\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/oytec\\\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/oytec.es\\\/#\\\/schema\\\/person\\\/84c11328cbacd3aab5590e508267a09b\",\"name\":\"Fernando L\u00f3pez\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"pt-PT\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/631c8a7f52cf451905a1bcbcf192e4e42ef600581600d7e3830c75b14e5e3805?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/631c8a7f52cf451905a1bcbcf192e4e42ef600581600d7e3830c75b14e5e3805?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/631c8a7f52cf451905a1bcbcf192e4e42ef600581600d7e3830c75b14e5e3805?s=96&d=mm&r=g\",\"caption\":\"Fernando L\u00f3pez\"},\"sameAs\":[\"http:\\\/\\\/oytec.es\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Fast & Furious eBR Implementation - OYTEC","description":"J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica.","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:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/","og_locale":"pt_PT","og_type":"article","og_title":"Fast & Furious eBR Implementation - OYTEC","og_description":"J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica.","og_url":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/","og_site_name":"OYTEC","article_published_time":"2026-06-16T06:00:35+00:00","article_modified_time":"2026-09-18T06:34:29+00:00","og_image":[{"width":2100,"height":748,"url":"https:\/\/www.oytec.es\/wp-content\/uploads\/FF-eBR_destacada-Blog_OYTEC-1.jpg","type":"image\/jpeg"}],"author":"Fernando L\u00f3pez","twitter_card":"summary_large_image","twitter_creator":"@OYTEC_MES","twitter_site":"@OYTEC_MES","twitter_misc":{"Escrito por":"Fernando L\u00f3pez","Tempo estimado de leitura":"8 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#article","isPartOf":{"@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/"},"author":{"name":"Fernando L\u00f3pez","@id":"https:\/\/oytec.es\/#\/schema\/person\/84c11328cbacd3aab5590e508267a09b"},"headline":"Fast &#038; Furious eBR Implementation","datePublished":"2026-06-16T06:00:35+00:00","dateModified":"2026-09-18T06:34:29+00:00","mainEntityOfPage":{"@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/"},"wordCount":1696,"publisher":{"@id":"https:\/\/oytec.es\/#organization"},"image":{"@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#primaryimage"},"thumbnailUrl":"https:\/\/www.oytec.es\/wp-content\/uploads\/FF-eBR_destacada-Blog_OYTEC-1.jpg","keywords":["2026","eBR","GMP","IA"],"articleSection":["Digitaliza\u00e7\u00e3o","GMP","IA","Transforma\u00e7\u00e3o Digital"],"inLanguage":"pt-PT"},{"@type":"WebPage","@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/","url":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/","name":"Fast & Furious eBR Implementation - OYTEC","isPartOf":{"@id":"https:\/\/oytec.es\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#primaryimage"},"image":{"@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#primaryimage"},"thumbnailUrl":"https:\/\/www.oytec.es\/wp-content\/uploads\/FF-eBR_destacada-Blog_OYTEC-1.jpg","datePublished":"2026-06-16T06:00:35+00:00","dateModified":"2026-09-18T06:34:29+00:00","description":"J\u00e1 n\u00e3o \u00e9 uma utopia realizar uma implementa\u00e7\u00e3o do Electronic Batch Record de forma r\u00e1pida e massiva em qualquer f\u00e1brica.","breadcrumb":{"@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#breadcrumb"},"inLanguage":"pt-PT","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/"]}]},{"@type":"ImageObject","inLanguage":"pt-PT","@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#primaryimage","url":"https:\/\/www.oytec.es\/wp-content\/uploads\/FF-eBR_destacada-Blog_OYTEC-1.jpg","contentUrl":"https:\/\/www.oytec.es\/wp-content\/uploads\/FF-eBR_destacada-Blog_OYTEC-1.jpg","width":2100,"height":748},{"@type":"BreadcrumbList","@id":"https:\/\/www.oytec.es\/pt\/fast-furious-ebr-implementation\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/www.oytec.es\/pt\/"},{"@type":"ListItem","position":2,"name":"Fast &#038; Furious eBR Implementation"}]},{"@type":"WebSite","@id":"https:\/\/oytec.es\/#website","url":"https:\/\/oytec.es\/","name":"OYTEC","description":"Digitalizando las operaciones Farma 4.0","publisher":{"@id":"https:\/\/oytec.es\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/oytec.es\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"pt-PT"},{"@type":"Organization","@id":"https:\/\/oytec.es\/#organization","name":"OYTEC","url":"https:\/\/oytec.es\/","logo":{"@type":"ImageObject","inLanguage":"pt-PT","@id":"https:\/\/oytec.es\/#\/schema\/logo\/image\/","url":"https:\/\/oytec.es\/wp-content\/uploads\/2021\/06\/cropped-OYTEC-Logo-transparent.png","contentUrl":"https:\/\/oytec.es\/wp-content\/uploads\/2021\/06\/cropped-OYTEC-Logo-transparent.png","width":175,"height":45,"caption":"OYTEC"},"image":{"@id":"https:\/\/oytec.es\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/x.com\/OYTEC_MES","https:\/\/www.linkedin.com\/company\/oytec\/"]},{"@type":"Person","@id":"https:\/\/oytec.es\/#\/schema\/person\/84c11328cbacd3aab5590e508267a09b","name":"Fernando L\u00f3pez","image":{"@type":"ImageObject","inLanguage":"pt-PT","@id":"https:\/\/secure.gravatar.com\/avatar\/631c8a7f52cf451905a1bcbcf192e4e42ef600581600d7e3830c75b14e5e3805?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/631c8a7f52cf451905a1bcbcf192e4e42ef600581600d7e3830c75b14e5e3805?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/631c8a7f52cf451905a1bcbcf192e4e42ef600581600d7e3830c75b14e5e3805?s=96&d=mm&r=g","caption":"Fernando L\u00f3pez"},"sameAs":["http:\/\/oytec.es"]}]}},"_links":{"self":[{"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/posts\/11021","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/comments?post=11021"}],"version-history":[{"count":1,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/posts\/11021\/revisions"}],"predecessor-version":[{"id":11032,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/posts\/11021\/revisions\/11032"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/media\/10900"}],"wp:attachment":[{"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/media?parent=11021"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/categories?post=11021"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.oytec.es\/pt\/wp-json\/wp\/v2\/tags?post=11021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}