{"id":17462,"date":"2021-09-20T17:03:28","date_gmt":"2021-09-20T17:03:28","guid":{"rendered":"https:\/\/www.tepsivo.com\/fichero-maestro-del-sistema-de-farmacovigilancia\/"},"modified":"2026-05-22T12:20:34","modified_gmt":"2026-05-22T12:20:34","slug":"fichero-maestro-del-sistema-de-farmacovigilancia","status":"publish","type":"page","link":"https:\/\/www.tepsivo.com\/es\/fichero-maestro-del-sistema-de-farmacovigilancia\/","title":{"rendered":"Fichero Maestro del Sistema de Farmacovigilancia"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; background_color=\u00bb#eff1f4&#8243; custom_padding=\u00bb||21px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; max_width=\u00bb943px\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb0px||||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb1px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb<\/p>\n<h2 style=%22font-weight: 500;%22>Fichero Maestro del Sistema de Farmacovigilancia  <\/h2>\n<p style=%22font-weight: 400;%22>El Archivo Maestro del Sistema de Farmacovigilancia (PSMF) es un documento clave exigido por la legislaci\u00f3n que debes elaborar y mantener de forma rutinaria para poder ofrecer una visi\u00f3n general de tu sistema global de farmacovigilancia en caso de inspecci\u00f3n.<\/p>\n<p>\u00bb content_phone=\u00bb<\/p>\n<h2 style=%22font-weight: 500;%22>Fichero Maestro del Sistema de Farmacovigilancia  <\/h2>\n<p style=%22font-weight: 400;%22>El Archivo Maestro del Sistema de Farmacovigilancia (PSMF) es un documento clave exigido por la legislaci\u00f3n que debes elaborar y mantener de forma rutinaria para poder ofrecer una visi\u00f3n general de tu sistema global de farmacovigilancia en caso de inspecci\u00f3n.<\/p>\n<p>\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb ul_font=\u00bb||||||||\u00bb ol_font=\u00bb||||||||\u00bb header_font=\u00bbMontserrat||||||||\u00bb header_2_font=\u00bbMontserrat|700|||||||\u00bb header_2_text_color=\u00bb#312533&#8243; header_2_font_size=\u00bb36px\u00bb header_2_line_height=\u00bb1.6em\u00bb header_3_font=\u00bbMerriweather|700|||||||\u00bb header_3_text_color=\u00bb#ffc47c\u00bb header_3_font_size=\u00bb18px\u00bb header_3_line_height=\u00bb1.8em\u00bb header_4_font=\u00bb||||||||\u00bb header_5_font=\u00bb||||||||\u00bb header_6_font=\u00bb||||||||\u00bb text_orientation=\u00bbcenter\u00bb max_width_tablet=\u00bb\u00bb max_width_phone=\u00bb\u00bb max_width_last_edited=\u00bbon|tablet\u00bb custom_margin=\u00bb0px||||false|false\u00bb custom_margin_tablet=\u00bb0px|0px||0px|false|false\u00bb custom_margin_phone=\u00bb0px||||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb0px||||false|false\u00bb custom_padding_tablet=\u00bb|0px||0px|false|false\u00bb custom_padding_phone=\u00bb0px||||false|false\u00bb custom_padding_last_edited=\u00bbon|tablet\u00bb header_2_font_size_tablet=\u00bb\u00bb header_2_font_size_phone=\u00bb28px\u00bb header_2_font_size_last_edited=\u00bbon|phone\u00bb header_3_font_size_tablet=\u00bb\u00bb header_3_font_size_phone=\u00bb14px\u00bb header_3_font_size_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2 style=\"font-weight: 500;\">Fichero Maestro del Sistema de Farmacovigilancia  <\/h2>\n<p style=\"font-weight: 400;\">El Archivo Maestro del Sistema de Farmacovigilancia (PSMF) es un documento clave exigido por la legislaci\u00f3n que debes elaborar y mantener de forma rutinaria para poder ofrecer una visi\u00f3n general de tu sistema global de farmacovigilancia en caso de inspecci\u00f3n.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb2_3,1_3&#8243; _builder_version=\u00bb4.16&#8243; width=\u00bb85%\u00bb max_width=\u00bb850px\u00bb custom_margin=\u00bb0px||||false|false\u00bb custom_padding=\u00bb0px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb2_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/tepsivo.com\/wp-content\/uploads\/2021\/09\/psmf-2.png\u00bb title_text=\u00bbpsmf\u00bb align=\u00bbcenter\u00bb disabled_on=\u00bboff|on|on\u00bb _builder_version=\u00bb4.16&#8243; max_height=\u00bb307px\u00bb max_height_tablet=\u00bb\u00bb max_height_phone=\u00bb202px\u00bb max_height_last_edited=\u00bbon|phone\u00bb custom_margin=\u00bb29px||||false|false\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb5px||10px||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb5px||0px||false|false\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb<\/p>\n<h4 style=%22font-weight: 500;%22>\u00bfC\u00f3mo podemos<br \/>\ndesarrollarlo para ti?  <\/h4>\n<p style=%22font-weight: 400;%22>No hay una gran magia detr\u00e1s de la elaboraci\u00f3n de un PSMF, la magia est\u00e1 en lo que describe. Si necesitas crear un nuevo sistema de farmacovigilancia, lo m\u00e1s f\u00e1cil es que recurras a nosotros. En ese caso, el PSMF ya estar\u00e1 preparado para ti gracias a nuestra plantilla de PSMF ya preparada, que describe nuestro sistema global de PV de principio a fin.    <\/p>\n<p style=%22font-weight: 400;%22>S\u00f3lo tendremos que trabajar contigo para rellenar un par de espacios en blanco, como tu sistema de calidad interno, la estructura org\u00e1nica, la informaci\u00f3n m\u00e9dica, los licenciatarios y otros socios, y algunas otras \u00e1reas.   <\/p>\n<p>\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_font=\u00bb||||||||\u00bb header_4_font=\u00bbMontserrat|600|||||||\u00bb header_4_text_color=\u00bb#312533&#8243; header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb text_orientation=\u00bbjustified\u00bb max_width=\u00bb600px\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb||43px|0px|false|false\u00bb custom_padding=\u00bb36px|0px||0px|false|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb15px|||0px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb header_4_font_size_phone=\u00bb20px\u00bb header_4_font_size_last_edited=\u00bboff|desktop\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4 style=\"font-weight: 500;\">\u00bfC\u00f3mo podemos desarrollarlo para ti?  <\/h4>\n<p style=\"font-weight: 400;\">No hay una gran magia detr\u00e1s de la elaboraci\u00f3n de un PSMF, la magia est\u00e1 en lo que describe. Si necesitas crear un nuevo sistema de farmacovigilancia, lo m\u00e1s f\u00e1cil es que recurras a nosotros. En ese caso, el PSMF ya estar\u00e1 preparado para ti gracias a nuestra plantilla de PSMF ya preparada, que describe nuestro sistema global de PV de principio a fin.    <\/p>\n<p style=\"font-weight: 400;\">S\u00f3lo tendremos que trabajar contigo para rellenar un par de espacios en blanco, como tu sistema de calidad interno, la estructura org\u00e1nica, la informaci\u00f3n m\u00e9dica, los licenciatarios y otros socios, y algunas otras \u00e1reas.   <\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bbhttps:\/\/www.tepsivo.com\/es\/ponte-en-contacto-con\/\u00bb button_text=\u00bbContacta con nosotros\u00bb button_alignment=\u00bbleft\u00bb button_alignment_tablet=\u00bb\u00bb button_alignment_phone=\u00bbcenter\u00bb button_alignment_last_edited=\u00bbon|phone\u00bb module_class=\u00bbsecondary-button\u00bb _builder_version=\u00bb4.16&#8243; custom_button=\u00bbon\u00bb button_text_size=\u00bb16px\u00bb button_text_color=\u00bb#ffffff\u00bb button_bg_color=\u00bb#b5302f\u00bb button_border_width=\u00bb2px\u00bb button_border_color=\u00bb#b5302f\u00bb button_border_radius=\u00bb19px\u00bb button_font=\u00bbMontserrat||||||||\u00bb button_use_icon=\u00bboff\u00bb custom_margin=\u00bb|10px||0px|false|false\u00bb custom_padding=\u00bb9px|80px|9px|80px|false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb9px|45px|9px|45px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; 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use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; width=\u00bb85%\u00bb max_width=\u00bb850px\u00bb custom_margin=\u00bb||||false|false\u00bb custom_padding=\u00bb7px||50px|0px|false|false\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb2_5&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_image src=\u00bbhttps:\/\/tepsivo.com\/wp-content\/uploads\/2021\/09\/when-do-you-need-psmf.png\u00bb title_text=\u00bbcu\u00e1ndo-necesitas-psmf\u00bb align=\u00bbcenter\u00bb _builder_version=\u00bb4.16&#8243; max_height=\u00bb274px\u00bb max_height_tablet=\u00bb\u00bb max_height_phone=\u00bb198px\u00bb max_height_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb70px||||false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb15px||||false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb3_5&#8243; _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb|||\u00bb global_colors_info=\u00bb{}\u00bb custom_padding__hover=\u00bb|||\u00bb][et_pb_text content_last_edited=\u00bboff|desktop\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_font=\u00bb||||||||\u00bb header_4_font=\u00bbMontserrat|600|||||||\u00bb header_4_text_color=\u00bb#312533&#8243; header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb text_orientation=\u00bbjustified\u00bb max_width=\u00bb600px\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb|||0px|false|false\u00bb custom_padding=\u00bb66px|0px||0px|false|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb15px|||0px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb header_4_font_size_phone=\u00bb20px\u00bb header_4_font_size_last_edited=\u00bboff|desktop\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4 style=\"font-weight: 500;\">\u00bfCu\u00e1ndo necesitas un PSMF?<\/h4>\n<p style=\"font-weight: 400;\">Si est\u00e1s planeando comercializar tu primer medicamento, debes tener un sistema de PV en el momento de presentar tu Solicitud de Autorizaci\u00f3n de Comercializaci\u00f3n (MAA). Y como ya sabes, el PSMF es una visi\u00f3n general de ese sistema, por lo que debe desarrollarse cuando presentes la MAA.   <\/p>\n<p style=\"font-weight: 400;\">Para tu solicitud real de MA, necesitar\u00e1s un Resumen del Sistema de Farmacovigilancia que incluir\u00e1 el n\u00famero del PSMF, la ubicaci\u00f3n del PSMF y detalles sobre tu Persona Cualificada para la Farmacovigilancia.  <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; custom_padding_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16&#8243; background_color=\u00bb#fafafa\u00bb custom_padding=\u00bb78px||21px|||\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb||0px||false|false\u00bb top_divider_style=\u00bbslant2&#8243; top_divider_color=\u00bb#ffffff\u00bb top_divider_height_tablet=\u00bb\u00bb top_divider_height_phone=\u00bb55px\u00bb top_divider_height_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row column_structure=\u00bb2_3,1_3&#8243; _builder_version=\u00bb4.16&#8243; width=\u00bb85%\u00bb max_width=\u00bb850px\u00bb custom_margin=\u00bb0px||||false|false\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb||0px||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb0px||0px||false|false\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb2_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/world-map-with-almost-transparent-background.png\u00bb title_text=\u00bbmapa-del-mundo-con-fondo-casi-transparente\u00bb align_tablet=\u00bb\u00bb align_phone=\u00bbcenter\u00bb align_last_edited=\u00bbon|phone\u00bb disabled_on=\u00bboff|on|on\u00bb _builder_version=\u00bb4.16&#8243; max_height_tablet=\u00bb\u00bb max_height_phone=\u00bb193px\u00bb max_height_last_edited=\u00bbon|phone\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb||5px||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb95px||||false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb5px||0px||false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][et_pb_text content_last_edited=\u00bboff|desktop\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_font=\u00bb||||||||\u00bb header_4_font=\u00bbMontserrat|600|||||||\u00bb header_4_text_color=\u00bb#312533&#8243; header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.6em\u00bb text_orientation=\u00bbjustified\u00bb max_width=\u00bb600px\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb|||0px|false|false\u00bb custom_padding=\u00bb36px|0px||0px|false|false\u00bb custom_padding_tablet=\u00bb|||0px|false|false\u00bb custom_padding_phone=\u00bb15px|||0px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb header_4_font_size_phone=\u00bb20px\u00bb header_4_font_size_last_edited=\u00bboff|desktop\u00bb text_orientation_tablet=\u00bbcenter\u00bb text_orientation_phone=\u00bbcenter\u00bb text_orientation_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4 style=\"font-weight: 500;\">\u00bfD\u00f3nde necesitas uno?<\/h4>\n<p style=\"font-weight: 400;\">En particular, el PSMF ha sido un requisito de los legisladores europeos, de modo que si est\u00e1s presente en al menos un mercado europeo, tienes que mantener un archivo maestro del sistema de farmacovigilancia.<\/p>\n<p style=\"font-weight: 400;\">Adem\u00e1s, puede que necesites mantener PSMF locales en varios pa\u00edses, por ejemplo Francia, Arabia Saud\u00ed o recientemente Reino Unido, entre otros pa\u00edses de todo el mundo.<\/p>\n<p style=\"font-weight:400;\">El PSMF del Reino Unido es un nuevo requisito tras el Brexit y forma parte de nuestro servicio global. Echa un vistazo a <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/pharmacovigilance-services\/brexit-pharmacovigilance-in-the-uk\/\">lo que podemos hacer por ti en el Reino Unido<\/a> y c\u00f3mo navegar por los requisitos de farmacovigilancia de la MHRA. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/tepsivo.com\/wp-content\/uploads\/2021\/11\/world-map-with-almost-transparent-background.png\u00bb title_text=\u00bbmapa-del-mundo-con-fondo-casi-transparente\u00bb disabled_on=\u00bbon|off|off\u00bb _builder_version=\u00bb4.16&#8243; max_height_tablet=\u00bb\u00bb max_height_phone=\u00bb193px\u00bb max_height_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb95px||||false|false\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=\u00bb4.16&#8243; background_color=\u00bb#fafafa\u00bb custom_margin=\u00bb0px||||false|false\u00bb custom_margin_tablet=\u00bb0px||||false|false\u00bb custom_margin_phone=\u00bb0px||||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb36px||2px||false|false\u00bb top_divider_color=\u00bb#ffffff\u00bb top_divider_height=\u00bb89px\u00bb top_divider_flip=\u00bbhorizontal\u00bb bottom_divider_color=\u00bb#ffffff\u00bb bottom_divider_height=\u00bb53px\u00bb bottom_divider_flip=\u00bbhorizontal\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row custom_padding_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16&#8243; background_color=\u00bb#ffffff\u00bb max_width=\u00bb876px\u00bb custom_padding=\u00bb30px||3px||false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb\u00bb border_radii=\u00bboff|10px|10px||\u00bb box_shadow_style=\u00bbpreset1&#8243; box_shadow_color=\u00bbrgba(0,0,0,0.1)\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text content_last_edited=\u00bboff|desktop\u00bb _builder_version=\u00bb4.16&#8243; header_4_font=\u00bbMontserrat|600|||||||\u00bb header_4_text_color=\u00bb#312533&#8243; header_4_font_size=\u00bb20px\u00bb header_4_line_height=\u00bb1.4em\u00bb max_width=\u00bb100%\u00bb custom_padding=\u00bb|15px||15px|false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb|29px||29px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h4 style=\"font-weight: 500; text-align: center;\">\u00bfY c\u00f3mo nos aseguramos de mantenerlo actualizado?  <\/h4>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb1_2,1_2&#8243; use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; background_color=\u00bb#ffffff\u00bb max_width=\u00bb876px\u00bb custom_padding=\u00bb1px||12px||false|false\u00bb border_radii=\u00bboff||||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/tepsivo.com\/wp-content\/uploads\/2021\/03\/tepsivo-automated-pv-solution-screenshot.png\u00bb title_text=\u00bbtepsivo-soluci\u00f3n-pv-automatizada-screenshot\u00bb _builder_version=\u00bb4.16&#8243; max_width=\u00bb89%\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb-13px||||false|false\u00bb custom_padding=\u00bb0px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text content_last_edited=\u00bboff|desktop\u00bb _builder_version=\u00bb4.16&#8243; custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb0px|0px||0px|false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb17px|55px|12px||false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb5px|29px||29px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"text-align: justify;\">En el sistema Tepsivo PV, los QPPV de la UE s\u00f3lo tienen que<span class=\"NormalTextRun SCXW69252997 BCX0\">entrar en<\/span> <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"><\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> en<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> nuestra<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> Plataforma<\/span> Tepsivo<span class=\"NormalTextRun SCXW69252997 BCX0\"> <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> patentada<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\"> y verlo todo por s\u00ed mismos<\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">, con la posibilidad de comentar directamente cualquier actividad <\/span><span class=\"NormalTextRun SCXW69252997 BCX0\">que consideren oportuna.<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text content_last_edited=\u00bboff|desktop\u00bb _builder_version=\u00bb4.16&#8243; custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb|55px|||false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb|29px||29px|false|false\u00bb custom_padding_last_edited=\u00bbon|desktop\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"text-align: justify;\"><span class=\"NormalTextRun SCXW23593537 BCX0\">Se garantiza el requisito legal de acceso al PSMF, as\u00ed como la supervisi\u00f3n de todas las tareas de PV <\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">garantizado <\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">en todo momento<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">. Decenas de horas de administraci\u00f3n ahorradas cada mes, y un QPPV de la UE m\u00e1s feliz<\/span><span class=\"NormalTextRun SCXW23593537 BCX0\">m\u00e1s eficaz y centrada en lo que debe importar y para lo que est\u00e1 formada.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb2&#8243; _builder_version=\u00bb4.16&#8243; background_color=\u00bb#ffffff\u00bb max_width=\u00bb876px\u00bb custom_margin=\u00bb-33px||||false|false\u00bb custom_padding=\u00bb1px||29px||false|false\u00bb border_radii=\u00bboff|||10px|10px\u00bb box_shadow_style=\u00bbpreset1&#8243; box_shadow_vertical=\u00bb16px\u00bb box_shadow_blur=\u00bb14px\u00bb box_shadow_color=\u00bbrgba(0,0,0,0.1)\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text content_tablet=\u00bb\u00bb content_phone=\u00bb<\/p>\n<p style=%22font-weight: 400;%22>M\u00e1s informaci\u00f3n sobre nuestro<a style=%22color: #b5302f; font-weight: 500;%22 href=%22https:\/\/www.tepsivo.com\/pharmacovigilance-services\/global-pharmacovigilance-system\/%22>sistema global de farmacovigilancia integral<br \/>\n<\/a><br \/>\n y c\u00f3mo lo gestionamos a trav\u00e9s de nuestra exclusiva <a style=%22color: #b5302f; font-weight: 500;%22 href=%22https:\/\/www.tepsivo.com\/es\/?page_id=17389%22>Plataforma Tepsivo<\/a>.<\/p>\n<p>\u00bb content_last_edited=\u00bbon|phone\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb1.6em\u00bb ul_font=\u00bb||||||||\u00bb ol_font=\u00bb||||||||\u00bb header_font=\u00bb||||||||\u00bb header_2_font=\u00bbMerriweather|700|||||||\u00bb header_2_font_size=\u00bb36px\u00bb header_2_line_height=\u00bb1.6em\u00bb header_3_font=\u00bbMerriweather|700|||||||\u00bb header_3_text_color=\u00bb#ffc47c\u00bb header_3_font_size=\u00bb18px\u00bb header_3_line_height=\u00bb1.8em\u00bb header_4_font=\u00bb||||||||\u00bb header_5_font=\u00bb||||||||\u00bb header_6_font=\u00bb||||||||\u00bb text_orientation=\u00bbcenter\u00bb max_width=\u00bb80%\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb1px|||||\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb45px||||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb header_2_font_size_tablet=\u00bb\u00bb header_2_font_size_phone=\u00bb20px\u00bb header_2_font_size_last_edited=\u00bbon|phone\u00bb header_3_font_size_tablet=\u00bb\u00bb header_3_font_size_phone=\u00bb14px\u00bb header_3_font_size_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"font-weight: 400;\">M\u00e1s informaci\u00f3n sobre nuestro <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/pharmacovigilance-services\/global-pharmacovigilance-system\/\">sistema global de farmacovigilancia integral<\/a><br \/>\ny c\u00f3mo lo gestionamos a trav\u00e9s de nuestra exclusiva <a style=\"color: #b5302f; font-weight: 500;\" href=\"https:\/\/www.tepsivo.com\/es\/plataforma-tepsivo\/\">Plataforma Tepsivo<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; custom_padding_last_edited=\u00bbon|desktop\u00bb _builder_version=\u00bb4.16&#8243; background_color=\u00bb#fafafa\u00bb use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#fafafa 0%|#ffffff 100%\u00bb background_color_gradient_start=\u00bb#fafafa\u00bb background_color_gradient_end=\u00bb#ffffff\u00bb custom_margin=\u00bb0px||||false|false\u00bb custom_margin_tablet=\u00bb0px||||false|false\u00bb custom_margin_phone=\u00bb0px||||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb2px||39px||false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb\u00bb top_divider_color=\u00bb#ffffff\u00bb top_divider_height=\u00bb89px\u00bb top_divider_flip=\u00bbhorizontal\u00bb bottom_divider_color=\u00bb#ffffff\u00bb bottom_divider_height=\u00bb53px\u00bb bottom_divider_flip=\u00bbhorizontal\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row use_custom_gutter=\u00bbon\u00bb gutter_width=\u00bb2&#8243; _builder_version=\u00bb4.16&#8243; background_enable_color=\u00bboff\u00bb width_tablet=\u00bb\u00bb width_phone=\u00bb100%\u00bb width_last_edited=\u00bbon|phone\u00bb max_width=\u00bb876px\u00bb custom_margin=\u00bb53px||||false|false\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb40px||21px||false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb1px||1px||false|false\u00bb border_radii=\u00bboff||||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text content_last_edited=\u00bboff|desktop\u00bb _builder_version=\u00bb4.16&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb1.6em\u00bb ul_font=\u00bb||||||||\u00bb ol_font=\u00bb||||||||\u00bb header_font=\u00bb||||||||\u00bb header_2_font=\u00bbMerriweather|700|||||||\u00bb header_2_font_size=\u00bb36px\u00bb header_2_line_height=\u00bb1.6em\u00bb header_3_font=\u00bbMerriweather|700|||||||\u00bb header_3_text_color=\u00bb#ffc47c\u00bb header_3_font_size=\u00bb18px\u00bb header_3_line_height=\u00bb1.8em\u00bb header_4_font=\u00bb||||||||\u00bb header_5_font=\u00bb||||||||\u00bb header_6_font=\u00bb||||||||\u00bb text_orientation=\u00bbcenter\u00bb max_width=\u00bb80%\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb1px|||||\u00bb custom_margin_tablet=\u00bb\u00bb custom_margin_phone=\u00bb|0px||0px|false|false\u00bb custom_margin_last_edited=\u00bbon|phone\u00bb custom_padding=\u00bb|0px||0px|false|false\u00bb header_2_font_size_tablet=\u00bb\u00bb header_2_font_size_phone=\u00bb20px\u00bb header_2_font_size_last_edited=\u00bbon|phone\u00bb header_3_font_size_tablet=\u00bb\u00bb header_3_font_size_phone=\u00bb14px\u00bb header_3_font_size_last_edited=\u00bbon|phone\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"font-weight: 400;\">Ponte en contacto con nosotros y podremos mostrarte c\u00f3mo utilizar nuestra plantilla de PSMF, siguiendo con precisi\u00f3n las directrices de PSMF requeridas. Podemos empezar con una muestra de PSMF y partir de ah\u00ed. <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; background_color=\u00bb#0c9cd1&#8243; use_background_color_gradient=\u00bbon\u00bb background_color_gradient_stops=\u00bb#F4F5F7 0%|#F4F5F7 100%\u00bb background_color_gradient_start=\u00bb#F4F5F7&#8243; background_color_gradient_end=\u00bb#F4F5F7&#8243; custom_margin=\u00bb-1px||||false|false\u00bb custom_padding=\u00bb0px||21px||false|false\u00bb top_divider_style=\u00bbslant2&#8243; top_divider_color=\u00bb#ffffff\u00bb top_divider_height=\u00bb75px\u00bb top_divider_flip=\u00bbhorizontal\u00bb top_divider_height_tablet=\u00bb\u00bb top_divider_height_phone=\u00bb55px\u00bb top_divider_height_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb92px|||||\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; 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text_font=\u00bbMontserrat||||||||\u00bb text_line_height=\u00bb2em\u00bb header_line_height=\u00bb1.5em\u00bb text_orientation=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p style=\"font-weight: 400;\">Sean cuales sean tus necesidades, estamos deseando ponernos en contacto contigo.<br \/>\nNo dudes en enviarnos un mensaje y nos pondremos en contacto contigo enseguida.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bbhttps:\/\/www.tepsivo.com\/es\/reserva-una-consulta-gratuita-de-15-minutos\/\u00bb button_text=\u00bbReserva GRATIS una consulta de 15 minutos\u00bb button_alignment=\u00bbcenter\u00bb module_class=\u00bbprimary-button\u00bb _builder_version=\u00bb4.16&#8243; custom_button=\u00bbon\u00bb button_text_size=\u00bb16px\u00bb button_text_color=\u00bb#b5302f\u00bb button_bg_color=\u00bb#ffffff\u00bb button_border_width=\u00bb2px\u00bb button_border_color=\u00bb#ffffff\u00bb button_border_radius=\u00bb19px\u00bb button_font=\u00bbMontserrat||||||||\u00bb button_use_icon=\u00bboff\u00bb custom_margin=\u00bb|10px||0px|false|false\u00bb custom_padding=\u00bb9px|30px|9px|30px|true|false\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][et_pb_button button_url=\u00bbhttps:\/\/www.tepsivo.com\/es\/ponte-en-contacto-con\/\u00bb button_text=\u00bbDeja un mensaje\u00bb button_alignment=\u00bbcenter\u00bb module_class=\u00bbsecondary-button\u00bb _builder_version=\u00bb4.16&#8243; custom_button=\u00bbon\u00bb button_text_size=\u00bb16px\u00bb button_text_color=\u00bb#ffffff\u00bb button_bg_color=\u00bb#b5302f\u00bb button_border_width=\u00bb2px\u00bb button_border_color=\u00bb#b5302f\u00bb button_border_radius=\u00bb19px\u00bb button_font=\u00bbMontserrat||||||||\u00bb button_use_icon=\u00bboff\u00bb custom_margin=\u00bb|10px||0px|false|false\u00bb custom_padding=\u00bb9px|80px|9px|80px|false|false\u00bb custom_padding_tablet=\u00bb\u00bb custom_padding_phone=\u00bb9px|45px|9px|45px|false|false\u00bb custom_padding_last_edited=\u00bbon|phone\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.16&#8243; background_color=\u00bb#F4F5F7&#8243; custom_padding=\u00bb5px||0px|||\u00bb border_color_all=\u00bb#8F909D\u00bb border_width_top=\u00bb1px\u00bb border_style_top=\u00bbdashed\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_row _builder_version=\u00bb4.16&#8243; custom_padding=\u00bb15px||14px|||\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.16&#8243; global_colors_info=\u00bb{}\u00bb][et_pb_text _builder_version=\u00bb4.27.4&#8243; text_font=\u00bbMontserrat||||||||\u00bb text_orientation=\u00bbcenter\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<p style=\"font-weight: 400;\">Tepsivo Oy | <span>Haartmaninkatu 4, Edificio 14, 00290, Helsinki, Finlandia<\/span> | N\u00famero de IVA FI31367614 | <a style=\"color: #7f7f7f;\" href=\"mailto:contact@tepsivo.com\">contact@tepsivo.com <\/a>| +358 402 204 698 | <a style=\"color: #7f7f7f;\" href=\"https:\/\/www.tepsivo.com\/privacy-policy\/\"><u>Pol\u00edtica de privacidad<\/u><\/a><\/p>\n<p>\n<script type=\"text\/javascript\">\n  var leady_track_key=\"zFCZE4xPhPJ6iw4D\";\n  (function(){\n    var l=document.createElement(\"script\");l.type=\"text\/javascript\";l.async=true;\n    l.src='https:\/\/t.leady.com\/'+leady_track_key+\"\/L.js\";\n    var s=document.getElementsByTagName(\"script\")[0];s.parentNode.insertBefore(l,s);\n  })();\n<\/script>\n<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Fichero Maestro del Sistema de Farmacovigilancia El Archivo Maestro del Sistema de Farmacovigilancia (PSMF) es un documento clave exigido por la legislaci&oacute;n que debes elaborar y mantener de forma rutinaria para poder ofrecer una visi&oacute;n general de tu sistema global de farmacovigilancia en caso de inspecci&oacute;n.&iquest;C&oacute;mo podemos desarrollarlo para ti? No hay una gran magia [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-17462","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Archivo maestro del sistema de farmacovigilancia (PSMF) | Configuraci\u00f3n r\u00e1pida con Tepsivo<\/title>\n<meta name=\"description\" content=\"Configura un nuevo sistema de farmacovigilancia con Tepsivo y tu PSMF se preparar\u00e1 autom\u00e1ticamente para ti. 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