{"id":11482,"date":"2023-04-05T11:42:01","date_gmt":"2023-04-05T09:42:01","guid":{"rendered":"https:\/\/oytec.es\/guia-de-fabricacio-electronica-ebr\/"},"modified":"2026-10-17T18:21:44","modified_gmt":"2026-10-17T16:21:44","slug":"guia-de-fabricacio-electronica-ebr","status":"publish","type":"page","link":"https:\/\/oytec.es\/ca\/guia-de-fabricacio-electronica-ebr\/","title":{"rendered":"Guia de Fabricaci\u00f3 Electr\u00f2nica (eBR)"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; prev_background_color=\u00bb#ffffff\u00bb _builder_version=\u00bb4.14.7&#8243; background_color=\u00bbrgba(0,0,0,0.34)\u00bb background_image=\u00bbhttps:\/\/oytec.es\/wp-content\/uploads\/2023\/04\/EBR_HEADER.jpg\u00bb background_blend=\u00bbdarken\u00bb custom_margin=\u00bb||21px|||\u00bb custom_padding=\u00bb||36px|||\u00bb top_divider_style=\u00bbarrow\u00bb top_divider_height=\u00bb30px\u00bb z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_row module_class=\u00bb et_pb_row_fullwidth\u00bb _builder_version=\u00bb4.9.2&#8243; width_tablet=\u00bb80%\u00bb width_phone=\u00bb\u00bb width_last_edited=\u00bbon|desktop\u00bb max_width=\u00bb80%\u00bb max_width_tablet=\u00bb80%\u00bb max_width_phone=\u00bb\u00bb max_width_last_edited=\u00bbon|desktop\u00bb custom_padding=\u00bb49px||0px|||\u00bb z_index_tablet=\u00bb500&#8243; make_fullwidth=\u00bbon\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb3.25&#8243; custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_font=\u00bbRoboto|700|||||||\u00bb text_text_color=\u00bb#FFFFFF\u00bb text_font_size=\u00bb35px\u00bb text_line_height=\u00bb1em\u00bb background_layout=\u00bbdark\u00bb custom_margin=\u00bb||12.5%||false|false\u00bb custom_padding=\u00bb0px||||false|false\u00bb animation_direction=\u00bbright\u00bb text_text_shadow_style=\u00bbpreset5&#8243; text_text_shadow_horizontal_length=\u00bb-0.02em\u00bb text_text_shadow_blur_strength=\u00bb0.1em\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span class=\"NormalTextRun SCXW168365144 BCX0\">GUIA DE FABRICACI\u00d3 ELECTR\u00d2NICA (<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW168365144 BCX0\">eBR<\/span><span class=\"NormalTextRun SCXW168365144 BCX0\">)<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb29px||12px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_5,1_5,1_5,1_5,1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb||54px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_text_color=\u00bb#23408f\u00bb text_font_size=\u00bb55px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><strong>+95%<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_font_size=\u00bb20px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span class=\"NormalTextRun SCXW181439639 BCX0\">Right First Time<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_text_color=\u00bb#23408f\u00bb text_font_size=\u00bb55px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><strong>-75%<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_font_size=\u00bb20px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span class=\"NormalTextRun SCXW150321225 BCX0\">Desviacions <\/span><span class=\"NormalTextRun SCXW150321225 BCX0\">en els <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW150321225 BCX0\">Batch<\/span><span class=\"NormalTextRun SCXW150321225 BCX0\"> <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW150321225 BCX0\">Record<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_text_color=\u00bb#23408f\u00bb text_font_size=\u00bb55px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><strong>-75%<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_font_size=\u00bb20px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span class=\"NormalTextRun SCXW51529328 BCX0\">Temps de revisi\u00f3 del <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW51529328 BCX0\">Batch<\/span><span class=\"NormalTextRun SCXW51529328 BCX0\"> <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW51529328 BCX0\">Record<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_text_color=\u00bb#23408f\u00bb text_font_size=\u00bb55px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><strong>-75%<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_font_size=\u00bb20px\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span data-contrast=\"auto\" xml:lang=\"ES-ES\" lang=\"ES-ES\" class=\"TextRun SCXW153655990 BCX0\"><span class=\"NormalTextRun SCXW153655990 BCX0\">Temps d&#8217;introducci\u00f3 de dades<\/span><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_text_color=\u00bb#23408f\u00bb text_font_size=\u00bb30px\u00bb text_line_height=\u00bb0.3em\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb-11px|-23px|10px|-23px|false|false\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><strong><span class=\"NormalTextRun SCXW77018116 BCX0\">21 CFR <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW77018116 BCX0\">Part<\/span><span class=\"NormalTextRun SCXW77018116 BCX0\"> 11 <\/span> <\/strong><\/p>\n<p><strong><span class=\"NormalTextRun SpellingErrorV2Themed SCXW77018116 BCX0\">Compliment<\/span><\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb text_font_size=\u00bb20px\u00bb text_orientation=\u00bbcenter\u00bb custom_margin=\u00bb27px|||||\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><span data-contrast=\"auto\" xml:lang=\"ES-ES\" lang=\"ES-ES\" class=\"TextRun SCXW26129279 BCX0\"><span class=\"NormalTextRun SCXW26129279 BCX0\"> Compliment GMP &#038; FDA<\/span><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.14.7&#8243; width=\u00bb100%\u00bb custom_margin=\u00bb9px||2px|||\u00bb custom_padding=\u00bb29px||0px|||\u00bb bottom_divider_height=\u00bb114px\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_2,1_2&#8243; _builder_version=\u00bb4.14.7&#8243; background_size=\u00bbinitial\u00bb background_position=\u00bbtop_left\u00bb background_repeat=\u00bbrepeat\u00bb custom_margin=\u00bb-1.2%|auto||auto|false|false\u00bb custom_padding=\u00bb22px||35px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb3.25&#8243; custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; text_font=\u00bb||||||||\u00bb text_font_size=\u00bb17px\u00bb text_orientation=\u00bbjustified\u00bb custom_padding=\u00bb||0px|||\u00bb animation_direction=\u00bbleft\u00bb z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb width__hover_enabled=\u00bbon|hover\u00bb]<\/p>\n<p><span data-contrast=\"none\">La substituci\u00f3 de la guia de fabricaci\u00f3 en paper per una guia electr\u00f2nica o <\/span><b><span data-contrast=\"none\">Electronic Batch Recording (EBR)<\/span><\/b><span data-contrast=\"none\"> representa una decisi\u00f3 estrat\u00e8gica que requereix la implicaci\u00f3 directa de la direcci\u00f3 general, at\u00e8s el seu impacte en les pol\u00edtiques i els procediments que regeixen la companyia. A m\u00e9s, el seu impacte ser\u00e0 molt transversal i afectar\u00e0 la major part dels departaments de f\u00e0brica.<\/span><span data-ccp-props=\"{\"134245417\":false,\"201341983\":1,\"335551550\":6,\"335551620\":6,\"335559737\":387,\"335559739\":160,\"335559740\":290}\"> <\/span><\/p>\n<p><span data-contrast=\"none\"><\/span><\/p>\n<p><span data-contrast=\"none\"><\/span><\/p>\n<p><span data-contrast=\"none\">La implementaci\u00f3 d&#8217;una Guia Electr\u00f2nica ens permetr\u00e0 la gesti\u00f3 i el seguiment de les ordres de fabricaci\u00f3, aix\u00ed com dels materials i equips (Logbooks electr\u00f2nics) que hi intervenen. Disposarem d&#8217;informaci\u00f3 de l&#8217;inventari en temps real, del flux dels materials (MFC) que intervenen en l&#8217;OF i del seu estat. A trav\u00e9s de l&#8217;EBR gestionarem les instruccions de fabricaci\u00f3 de manera interactiva, predeterminant els fluxos de treball i seq\u00fcenciant amb precisi\u00f3 els diferents passos a executar. Tot plegat de manera electr\u00f2nica, amb revisi\u00f3 per excepci\u00f3 en temps real.     <\/span><span data-ccp-props=\"{\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559739\":160,\"335559740\":259}\"> <\/span><\/p>\n<p><span data-ccp-props=\"{\"134245417\":false,\"201341983\":1,\"335551550\":6,\"335551620\":6,\"335559737\":387,\"335559739\":160,\"335559740\":290}\"><\/span><\/p>\n<p><span data-ccp-props=\"{\"134245417\":false,\"201341983\":1,\"335551550\":6,\"335551620\":6,\"335559737\":387,\"335559739\":160,\"335559740\":290}\"><\/span><\/p>\n<p><span data-ccp-props=\"{\"134245417\":false,\"201341983\":1,\"335551550\":6,\"335551620\":6,\"335559737\":387,\"335559739\":160,\"335559740\":290}\"><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb3.25&#8243; custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_image src=\u00bbhttps:\/\/oytec.es\/wp-content\/uploads\/2023\/04\/EBR.jpg\u00bb title_text=\u00bbEBR\u00bb _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb0px|||||\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.9.3&#8243; _module_preset=\u00bbdefault\u00bb background_color=\u00bb#eef1f7&#8243; background_image=\u00bbhttps:\/\/www.oytec.es\/wp-content\/uploads\/2021\/03\/Footer_Oytec_400.jpg\u00bb background_enable_image=\u00bboff\u00bb custom_padding=\u00bb3px||3px|||\u00bb saved_tabs=\u00bball\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb1_5,1_5,1_5,1_5,1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.9.2&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb-9px||20px||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<p><strong>BARCELONA<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbTexto\u00bb _builder_version=\u00bb4.14.7&#8243; text_font=\u00bbRoboto||||||||\u00bb text_text_color=\u00bb#636363&#8243; header_3_font=\u00bb|||on|||||\u00bb header_6_text_color=\u00bb#7c7c7c\u00bb background_layout=\u00bbdark\u00bb custom_padding=\u00bb0px|||||\u00bb z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<aside>edifici @SANTCUGAT<\/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>\n<p>info@oytec.es<\/p>\n<\/div>\n<\/div>\n<\/aside>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.9.2&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb-9px||20px||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<p><strong>MADRID<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_text admin_label=\u00bbTexto\u00bb _builder_version=\u00bb4.14.7&#8243; text_font=\u00bbRoboto||||||||\u00bb text_text_color=\u00bb#636363&#8243; header_3_font=\u00bb|||on|||||\u00bb header_6_text_color=\u00bb#7c7c7c\u00bb background_layout=\u00bbdark\u00bb custom_padding=\u00bb0px|||||\u00bb z_index_tablet=\u00bb500&#8243; global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<p>Carretera M-603 de Fuencarral a Alcobendas<\/p>\n<p>Portal n\u00fam. 44, Edifici 6, Planta Baixa, Porta 23<\/p>\n<p>28108, Alcobendas, Madrid<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.9.2&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_image src=\u00bbhttps:\/\/oytec.es\/wp-content\/uploads\/2024\/10\/AENOR-ER-05242021-18-10-2024-ES-15-10-2024.png\u00bb title_text=\u00bbAENOR-ER-05242021-18-10-2024-ES-15-10-2024&#8243; show_in_lightbox=\u00bbon\u00bb align=\u00bbcenter\u00bb _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb width=\u00bb50%\u00bb max_width=\u00bb50%\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_image src=\u00bbhttps:\/\/oytec.es\/wp-content\/uploads\/2024\/10\/IQNET-ES-05242021-18-10-2024-EN-15-10-2024.png\u00bb title_text=\u00bbIQNET-ES-05242021-18-10-2024-EN-15-10-2024&#8243; show_in_lightbox=\u00bbon\u00bb align=\u00bbcenter\u00bb _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb width=\u00bb50%\u00bb max_width=\u00bb50%\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_5&#8243; _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.14.7&#8243; _module_preset=\u00bbdefault\u00bb background_color=\u00bbRGBA(255,255,255,0)\u00bb custom_margin=\u00bb-6px|||||\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<p style=\"text-align: right;\"><span style=\"color: #808080;\"><a href=\"https:\/\/oytec.es\/en\/contact\/\" style=\"color: #808080;\">CONTACTE<\/a><\/span><\/p>\n<p style=\"text-align: right;\"><span style=\"color: #808080;\"><a href=\"https:\/\/oytec.es\/en\/blog\/\" style=\"color: #808080;\">BLOG<\/a><\/span><\/p>\n<p style=\"text-align: right;\"><a href=\"https:\/\/oytec.es\/en\/legal\/\"><span style=\"color: #808080;\">AV\u00cdS 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>GUIA DE FABRICACI\u00d3 ELECTR\u00d2NICA (eBR)+95%Right First Time-75%Desviacions en els Batch Record-75%Temps de revisi\u00f3 del Batch Record-75%Temps d&#8217;introducci\u00f3 de dades21 CFR Part 11 Compliment Compliment GMP &#038; FDALa substituci\u00f3 de la guia de fabricaci\u00f3 en paper per una guia electr\u00f2nica o Electronic Batch Recording (EBR) representa una decisi\u00f3 estrat\u00e8gica que requereix la implicaci\u00f3 directa de la [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11483,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"class_list":["post-11482","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - 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