{"id":156523,"date":"2025-08-28T08:07:03","date_gmt":"2025-08-28T08:07:03","guid":{"rendered":"https:\/\/controltecnica.com\/sat\/?page_id=156523"},"modified":"2026-04-17T08:38:15","modified_gmt":"2026-04-17T08:38:15","slug":"validacion-y-cualificacion","status":"publish","type":"page","link":"https:\/\/controltecnica.com\/sat\/validacion-y-cualificacion\/","title":{"rendered":"Validaci\u00f3n y cualificaci\u00f3n"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=\u00bbyes\u00bb row_height_percent=\u00bb0&#8243; override_padding=\u00bbyes\u00bb h_padding=\u00bb7&#8243; top_padding=\u00bb2&#8243; bottom_padding=\u00bb2&#8243; back_color=\u00bbaccent\u00bb overlay_alpha=\u00bb75&#8243; overlay_color_blend=\u00bbmultiply\u00bb overlay_animated=\u00bbyes\u00bb overlay_animated_size=\u00bb0.7&#8243; gutter_size=\u00bb3&#8243; column_width_percent=\u00bb100&#8243; shift_y=\u00bb0&#8243; z_index=\u00bb0&#8243; bottom_divider=\u00bbgradient\u00bb content_parallax=\u00bb3&#8243; uncode_shortcode_id=\u00bb513072&#8243; back_color_type=\u00bbuncode-palette\u00bb overlay_color_type=\u00bbuncode-solid\u00bb overlay_color_solid=\u00bb#003882&#8243; overlay_animated_1_color_type=\u00bbuncode-solid\u00bb overlay_animated_1_color_solid=\u00bb#244d8d\u00bb overlay_animated_2_color_type=\u00bbuncode-solid\u00bb overlay_animated_2_color_solid=\u00bb#ef0b00&#8243;][vc_column column_width_percent=\u00bb100&#8243; position_vertical=\u00bbbottom\u00bb gutter_size=\u00bb4&#8243; style=\u00bbdark\u00bb overlay_alpha=\u00bb50&#8243; shift_x=\u00bb0&#8243; shift_y=\u00bb0&#8243; shift_y_down=\u00bb0&#8243; z_index=\u00bb0&#8243; medium_width=\u00bb0&#8243; mobile_width=\u00bb0&#8243; width=\u00bb1\/1&#8243; uncode_shortcode_id=\u00bb138994&#8243;][vc_row_inner limit_content=\u00bb\u00bb][vc_column_inner column_width_percent=\u00bb100&#8243; position_vertical=\u00bbmiddle\u00bb align_horizontal=\u00bbalign_center\u00bb gutter_size=\u00bb3&#8243; style=\u00bbdark\u00bb overlay_alpha=\u00bb50&#8243; shift_x=\u00bb0&#8243; shift_y=\u00bb0&#8243; shift_y_down=\u00bb0&#8243; z_index=\u00bb0&#8243; medium_width=\u00bb0&#8243; mobile_width=\u00bb0&#8243; width=\u00bb1\/1&#8243; uncode_shortcode_id=\u00bb181497&#8243;][vc_custom_heading text_size=\u00bbh1&#8243; text_weight=\u00bb500&#8243; uncode_shortcode_id=\u00bb723934&#8243;]Validaci\u00f3n y cualificaci\u00f3n<\/p>\n<p>[\/vc_custom_heading][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row unlock_row_content=\u00bbyes\u00bb row_height_percent=\u00bb0&#8243; override_padding=\u00bbyes\u00bb h_padding=\u00bb7&#8243; top_padding=\u00bb2&#8243; bottom_padding=\u00bb4&#8243; overlay_alpha=\u00bb50&#8243; gutter_size=\u00bb2&#8243; column_width_percent=\u00bb100&#8243; shift_y=\u00bb0&#8243; z_index=\u00bb0&#8243; content_parallax=\u00bb0&#8243; uncode_shortcode_id=\u00bb181334&#8243;][vc_column column_width_percent=\u00bb100&#8243; gutter_size=\u00bb3&#8243; overlay_alpha=\u00bb50&#8243; shift_x=\u00bb0&#8243; shift_y=\u00bb0&#8243; shift_y_down=\u00bb0&#8243; z_index=\u00bb0&#8243; medium_width=\u00bb0&#8243; mobile_width=\u00bb0&#8243; width=\u00bb1\/1&#8243; uncode_shortcode_id=\u00bb192232&#8243;][vc_row_inner row_inner_height_percent=\u00bb0&#8243; back_color=\u00bbcolor-lxmt\u00bb overlay_alpha=\u00bb50&#8243; gutter_size=\u00bb3&#8243; shift_y=\u00bb0&#8243; z_index=\u00bb0&#8243; limit_content=\u00bb\u00bb uncode_shortcode_id=\u00bb389966&#8243; back_color_type=\u00bbuncode-palette\u00bb][vc_column_inner column_width_percent=\u00bb100&#8243; gutter_size=\u00bb2&#8243; back_color=\u00bbcolor-xsdn\u00bb overlay_alpha=\u00bb50&#8243; radius=\u00bblg\u00bb shift_x=\u00bb0&#8243; shift_y=\u00bb0&#8243; shift_y_down=\u00bb0&#8243; z_index=\u00bb0&#8243; medium_width=\u00bb0&#8243; mobile_width=\u00bb0&#8243; sticky=\u00bbyes\u00bb width=\u00bb1\/3&#8243; uncode_shortcode_id=\u00bb489120&#8243; back_color_type=\u00bbuncode-palette\u00bb][vc_custom_heading text_color=\u00bbcolor-xsdn\u00bb heading_semantic=\u00bbh6&#8243; text_size=\u00bbh5&#8243; text_weight=\u00bb500&#8243; badge_style=\u00bbyes\u00bb back_color=\u00bbcolor-vyce\u00bb radius=\u00bbstd\u00bb uncode_shortcode_id=\u00bb963837&#8243; back_color_type=\u00bbuncode-palette\u00bb text_color_type=\u00bbuncode-palette\u00bb el_class=\u00bbhide\u00bb]DIVISI\u00d3N SAT[\/vc_custom_heading][vc_column_text text_lead=\u00bbyes\u00bb text_color=\u00bbaccent\u00bb uncode_shortcode_id=\u00bb179086&#8243; text_color_type=\u00bbuncode-palette\u00bb]<\/p>\n<p class=\"p1\">En <strong>CALTECNICA INGENIEROS<\/strong> ayudamos a las empresas del sector farmac\u00e9utico, biotecnol\u00f3gico y sanitario a garantizar la conformidad regulatoria y la excelencia operativa de sus equipos e instalaciones mediante servicios especializados de validaci\u00f3n y cualificaci\u00f3n <strong>IQ, OQ y PQ.<\/strong><\/p>\n<p>[\/vc_column_text][vc_single_image media=\u00bb156673&#8243; media_width_percent=\u00bb100&#8243; alignment=\u00bbcenter\u00bb shape=\u00bbimg-round\u00bb uncode_shortcode_id=\u00bb919743&#8243;][vc_button button_color=\u00bbcolor-vyce\u00bb size=\u00bblink\u00bb btn_link_size=\u00bbh5&#8243; btn_link_underline=\u00bbbtn-underline-out\u00bb custom_typo=\u00bbyes\u00bb font_family=\u00bbfont-555555&#8243; font_weight=\u00bb500&#8243; uncode_shortcode_id=\u00bb710544&#8243; link=\u00bburl:https%3A%2F%2Fcontroltecnica.com%2Fsat%2Fcontacto%2F|title:Asistencia%20T%C3%A9cnica|target:_blank\u00bb button_color_type=\u00bbuncode-palette\u00bb]Solicita una cita[\/vc_button][vc_empty_space empty_h=\u00bb1&#8243; mobile_visibility=\u00bbyes\u00bb][\/vc_column_inner][vc_column_inner column_width_percent=\u00bb100&#8243; gutter_size=\u00bb2&#8243; overlay_alpha=\u00bb50&#8243; shift_x=\u00bb0&#8243; shift_y=\u00bb0&#8243; shift_y_down=\u00bb0&#8243; z_index=\u00bb0&#8243; medium_width=\u00bb0&#8243; mobile_width=\u00bb0&#8243; width=\u00bb2\/3&#8243; uncode_shortcode_id=\u00bb184600&#8243;][vc_empty_space empty_h=\u00bb1&#8243; mobile_visibility=\u00bbyes\u00bb][vc_custom_heading text_size=\u00bbh4&#8243; text_weight=\u00bb700&#8243; uncode_shortcode_id=\u00bb192845&#8243;]Servicios de Cualificaci\u00f3n y Validaci\u00f3n IQ\/OQ\/PQ: Garant\u00eda de cumplimiento GMP[\/vc_custom_heading][vc_column_text uncode_shortcode_id=\u00bb156369&#8243; el_class=\u00bbtext-justify\u00bb]<\/p>\n<p class=\"p1\">CALTECNICA ofrece servicios especializados de <strong>Cualificaci\u00f3n de Instalaci\u00f3n (IQ), Operacional (OQ) y de Desempe\u00f1o (PQ),<\/strong> asegurando el estricto cumplimiento de las normativas GMP y los est\u00e1ndares internacionales.<\/p>\n<p class=\"p1\"><strong>\u00bfQu\u00e9 incluimos en nuestros protocolos de validaci\u00f3n?<\/strong><\/p>\n<p class=\"p1\">Nuestro enfoque integral cubre todas las etapas cr\u00edticas para asegurar que sus equipos funcionen exactamente como se espera:<\/p>\n<p>[\/vc_column_text][uncode_list icon=\u00bbfa fa-play\u00bb icon_color=\u00bbcolor-vyce\u00bb uncode_shortcode_id=\u00bb725196&#8243; icon_color_type=\u00bbuncode-palette\u00bb]<\/p>\n<ul>\n<li><strong>IQ (Cualificaci\u00f3n de la instalaci\u00f3n):<\/strong>Verificamos que el equipo haya sido entregado e instalado correctamente, cumpliendo con las especificaciones del fabricante y los requisitos del entorno farmac\u00e9utico (conexiones, documentaci\u00f3n t\u00e9cnica, calibraci\u00f3n de componentes\u2026).<\/li>\n<li><strong>OQ (Cualificaci\u00f3n de la operaci\u00f3n):<\/strong>\u00a0Verificamos que el equipo funcione seg\u00fan sus especificaciones funcionales y seg\u00fan los requisitos de GMP<b> <\/b>y con los est\u00e1ndares definidos en las farmacopeas (como la USP de EE. UU. o la Ph. Eur. Europea) o en gu\u00edas de la EMA (como las ICH), incluyendo sistemas de alarma, controles de seguridad y ciclos de operaci\u00f3n.<\/li>\n<li><strong>PQ (Cualificaci\u00f3n del desempe\u00f1o o prestacional): <\/strong>Validamos que el equipo, operando de forma integrada y con carga real, mantenga un desempe\u00f1o consistente y estable a lo largo del tiempo.<\/li>\n<\/ul>\n<p>[\/uncode_list][vc_empty_space empty_h=\u00bb1&#8243; mobile_visibility=\u00bbyes\u00bb][vc_custom_heading text_size=\u00bbh4&#8243; text_weight=\u00bb700&#8243; uncode_shortcode_id=\u00bb662594&#8243;]Equipos en los que somos expertos[\/vc_custom_heading][vc_column_text uncode_shortcode_id=\u00bb135071&#8243; el_class=\u00bbtext-justify\u00bb]<\/p>\n<p class=\"p1\">Contamos con la tecnolog\u00eda y el conocimiento t\u00e9cnico para cualificar equipos cr\u00edticos en laboratorios y plantas de producci\u00f3n:<\/p>\n<table class=\"table-wide\" style=\"background-color: white;\">\n<thead>\n<tr>\n<th>Control T\u00e9rmico y Estabilidad<\/th>\n<th>Esterilizaci\u00f3n y Procesado<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>C\u00e1maras clim\u00e1ticas:<\/strong> Mapeos t\u00e9rmicos y de humedad para estudios de estabilidad.<\/td>\n<td><strong>Autoclaves<\/strong>: Validaci\u00f3n de ciclos de esterilizaci\u00f3n y penetraci\u00f3n de calor seg\u00edun norma ISO 17665<\/td>\n<\/tr>\n<tr>\n<td><strong>C\u00e1maras frigor\u00edficas y congeladores<\/strong>: Control riguroso de la cadena de fr\u00edo. Validaci\u00f3n de temperaturas cr\u00edticas de almacenamiento.<\/td>\n<td><strong>Centr\u00edfugas<\/strong>: Verificaci\u00f3n de velocidad, tiempo y estabilidad de temperatura.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>[\/vc_column_text][vc_column_text uncode_shortcode_id=\u00bb540740&#8243; el_class=\u00bbtext-justify\u00bb]<\/p>\n<p class=\"p1\">Adem\u00e1s podemos cualificar los softwares de registro y monitorizaci\u00f3n asociados.<\/p>\n<p>[\/vc_column_text][vc_empty_space empty_h=\u00bb1&#8243; mobile_visibility=\u00bbyes\u00bb][vc_custom_heading text_size=\u00bbh4&#8243; text_weight=\u00bb700&#8243; uncode_shortcode_id=\u00bb168252&#8243;]\u00bfPor qu\u00e9 confiar en CALTECNICA para tus auditor\u00edas?[\/vc_custom_heading][vc_column_text uncode_shortcode_id=\u00bb126084&#8243; el_class=\u00bbtext-justify\u00bb]<\/p>\n<p class=\"p1\">Tras m\u00e1s de 20 a\u00f1os realizando este tipo de cualificaciones y validaciones, entregamos <strong>tranquilidad<\/strong>:<\/p>\n<ol class=\"ol1\">\n<li class=\"li1\"><strong>Protocolos detallados:<\/strong> Documentaci\u00f3n robusta lista para ser presentada ante organismos reguladores (AEMPS, EMA, FDA). 20 a\u00f1os de experiencia exitosa en las grandes farmac\u00e9uticas de los mercados espa\u00f1ol y portugu\u00e9s nos avalan.<\/li>\n<li class=\"li1\"><strong>Trazabilidad total: <\/strong>Utilizamos equipos de medici\u00f3n calibrados con trazabilidad amparada por la acreditaci\u00f3n ISO 17025.<\/li>\n<li class=\"li1\"><strong>Experiencia sectorial:<\/strong> Conocemos los retos espec\u00edficos de la industria farmac\u00e9utica y nos adaptamos a los cronogramas de producci\u00f3n para minimizar tiempos de inactividad.<\/li>\n<\/ol>\n<p class=\"p1\"><strong>Nuestro objetivo:<\/strong> Que puedas concentrarte en la ciencia y la producci\u00f3n, mientras nosotros nos aseguramos de que la tecnolog\u00eda nunca te falle.<\/p>\n<p>[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row unlock_row_content=\u00bbyes\u00bb row_height_percent=\u00bb0&#8243; override_padding=\u00bbyes\u00bb h_padding=\u00bb7&#8243; top_padding=\u00bb2&#8243; bottom_padding=\u00bb2&#8243; back_color=\u00bbaccent\u00bb overlay_alpha=\u00bb75&#8243; overlay_color_blend=\u00bbmultiply\u00bb overlay_animated=\u00bbyes\u00bb overlay_animated_size=\u00bb0.7&#8243; gutter_size=\u00bb3&#8243; column_width_percent=\u00bb100&#8243; shift_y=\u00bb0&#8243; z_index=\u00bb0&#8243; bottom_divider=\u00bbgradient\u00bb content_parallax=\u00bb3&#8243; uncode_shortcode_id=\u00bb513072&#8243; back_color_type=\u00bbuncode-palette\u00bb [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"iawp_total_views":128,"footnotes":""},"class_list":["post-156523","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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