{"id":11,"date":"2026-07-15T03:18:22","date_gmt":"2026-07-15T03:18:22","guid":{"rendered":"https:\/\/fenggu-bio.com\/quality-compliance\/"},"modified":"2026-07-20T01:09:10","modified_gmt":"2026-07-20T01:09:10","slug":"quality-compliance","status":"publish","type":"page","link":"https:\/\/fenggu-bio.com\/es\/quality-compliance\/","title":{"rendered":"Calidad y cumplimiento normativo"},"content":{"rendered":"<style>\n.entry-title,.ast-single-post .entry-header{display:none!important}\n.fg-full{width:100vw;position:relative;left:50%;right:50%;margin-left:-50vw;margin-right:-50vw}\n.fg-wrap{max-width:1120px;margin:0 auto;padding:0 24px}\n.fg-page{font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,\"Helvetica Neue\",Arial,\"PingFang SC\",\"Microsoft YaHei\",sans-serif;color:#1e2838;line-height:1.65}\n.fg-page h2{font-size:29px;color:#002B78;margin:0 0 14px;line-height:1.22}\n.fg-lead{font-size:16.5px;color:#4a5568;max-width:840px}\n.fg-sec{padding:62px 0}.fg-sec.alt{background:#eff4fb}\n.fg-center{text-align:center}.fg-center .fg-lead{margin:0 auto}\n.fg-tag{display:inline-block;background:#e3ecfa;color:#003AA1;font-weight:700;font-size:12px;letter-spacing:.7px;padding:5px 13px;border-radius:20px;text-transform:uppercase;margin-bottom:14px}\n.fg-btn{display:inline-block;padding:14px 30px;border-radius:6px;font-weight:600;font-size:16px;text-decoration:none;margin:0 10px 10px 0}\n.fg-btn-p{background:#EC001B;color:#fff}.fg-btn-o{background:transparent;color:#fff;border:2px solid rgba(255,255,255,.75)}\n.fg-phero{position:relative;padding:80px 0 68px;background:linear-gradient(100deg,rgba(0,22,60,.92),rgba(0,30,90,.76) 60%,rgba(0,58,161,.5) 100%),url(\/wp-content\/uploads\/site\/scene2.jpg) center\/cover no-repeat;color:#fff}\n.fg-phero h1{font-size:42px;line-height:1.14;margin:0 0 16px;color:#fff;max-width:840px;font-weight:700}\n.fg-phero p{font-size:17px;color:#dce7f7;max-width:720px;margin:0}\n.fg-eyebrow{display:inline-block;background:rgba(255,255,255,.14);border:1px solid rgba(255,255,255,.28);color:#e3ecfa;font-size:12.5px;font-weight:600;letter-spacing:1.2px;text-transform:uppercase;padding:6px 15px;border-radius:20px;margin-bottom:20px}\n.fg-crumb{font-size:13px;color:#9db4dc;margin-bottom:18px}.fg-crumb a{color:#c9d8f2;text-decoration:none}\n\/* standards grid *\/\n.fg-std{display:grid;grid-template-columns:repeat(3,1fr);gap:18px;margin-top:34px;text-align:left}\n.fg-std .s{background:#fff;border:1px solid #dbe3f0;border-radius:10px;padding:22px 22px;box-shadow:0 2px 12px rgba(0,58,161,.05)}\n.fg-std .s b{display:block;color:#003AA1;font-size:16px;margin-bottom:6px}\n.fg-std .s span{font-size:13.5px;color:#5a6472}\n\/* QA process list *\/\n.fg-tlist{margin:14px 0 0;padding:0;list-style:none;max-width:900px}\n.fg-tlist li{font-size:15px;color:#3a4658;padding:9px 0 9px 28px;position:relative}\n.fg-tlist li::before{content:\"\\203A\";position:absolute;left:5px;top:7px;color:#EC001B;font-weight:700;font-size:18px}\n\/* certs *\/\n.fg-certs{display:grid;grid-template-columns:repeat(6,1fr);gap:14px;margin-top:30px}\n.fg-certs a{background:#fff;border:1px solid #dbe3f0;border-radius:8px;padding:8px;box-shadow:0 2px 10px rgba(0,58,161,.06);display:block;transition:.18s}\n.fg-certs a:hover{box-shadow:0 6px 20px rgba(0,58,161,.16);transform:translateY(-2px)}\n.fg-certs img{width:100%;display:block;border-radius:3px}\n.fg-cta{background:linear-gradient(rgba(0,22,60,.9),rgba(0,35,100,.9)),url(\/wp-content\/uploads\/site\/scene3.jpg) center\/cover;color:#fff;text-align:center}\n.fg-cta h2{color:#fff;font-size:31px}.fg-cta p{color:#dce7f7;font-size:16.5px;max-width:620px;margin:8px auto 26px}\n@media(max-width:900px){.fg-std{grid-template-columns:1fr}.fg-certs{grid-template-columns:repeat(3,1fr)}.fg-phero h1{font-size:31px}.fg-page h2{font-size:23px}}\n<\/style>\n<div class=\"fg-page\">\n<section class=\"fg-full fg-phero\">\n<div class=\"fg-wrap\">\n<div class=\"fg-crumb\"><a href=\"\/es\/\">Inicio<\/a> \u203a Calidad y cumplimiento<\/div>\n<p>  <span class=\"fg-eyebrow\">Calidad y cumplimiento normativo<\/span><\/p>\n<h1>Construido y documentado para la fabricaci\u00f3n regulada<\/h1>\n<p>Nuestra tecnolog\u00eda est\u00e1 dise\u00f1ada, fabricada y validada de acuerdo con los est\u00e1ndares que los fabricantes de productos farmac\u00e9uticos y de ciencias de la vida deben cumplir \u2014 por lo que se integra en su sistema de calidad, no alrededor de \u00e9l.<\/p>\n<\/div>\n<\/section>\n<p><!-- standards wall --><\/p>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap fg-center\">\n  <span class=\"fg-tag\">Est\u00e1ndares y alineaci\u00f3n normativa<\/span><\/p>\n<h2>Dise\u00f1ado de acuerdo con los est\u00e1ndares que esperan sus auditores<\/h2>\n<div class=\"fg-std\">\n<div class=\"s\"><b>cGMP<\/b><span>Las Buenas Pr\u00e1cticas de Fabricaci\u00f3n actuales \u2014 el punto de referencia para cada decisi\u00f3n de dise\u00f1o y construcci\u00f3n.<\/span><\/div>\n<div class=\"s\"><b>FDA 21 CFR, parte 11<\/b><span>Registros y firmas electr\u00f3nicos: rastros de auditor\u00eda, control de acceso e integridad de los datos en nuestros sistemas de control.<\/span><\/div>\n<div class=\"s\"><b>Anexo 1 de las BPF de la UE<\/b><span>Fabricaci\u00f3n de productos medicinales est\u00e9riles \u2014 dise\u00f1o para la barrera, el flujo de aire y el control de la contaminaci\u00f3n.<\/span><\/div>\n<div class=\"s\"><b>ISO 14644<\/b><span>Clasificaci\u00f3n y ensayo de la calidad del aire en salas limpias (capacidad ISO 5 \/ Grado A).<\/span><\/div>\n<div class=\"s\"><b>ISO 10648-2<\/b><span>Clasificaci\u00f3n de la hermeticidad de los recintos de contenci\u00f3n para aisladores y equipos herm\u00e9ticos.<\/span><\/div>\n<div class=\"s\"><b>USP 1208<\/b><span>Test de esterilidad en sistemas de aisladores \u2014 validaci\u00f3n de la eficacia de la descontaminaci\u00f3n con VHP.<\/span><\/div>\n<\/p><\/div>\n<\/div>\n<\/section>\n<p><!-- QA approach --><\/p>\n<section class=\"fg-sec alt\">\n<div class=\"fg-wrap\">\n  <span class=\"fg-tag\">Nuestro enfoque de calidad<\/span><\/p>\n<h2>La calidad se verifica en cada etapa, no solo al final<\/h2>\n<ul class=\"fg-tlist\">\n<li>Calificaci\u00f3n de dise\u00f1o de acuerdo con los requisitos del usuario y los criterios de cGMP antes de comenzar la fabricaci\u00f3n<\/li>\n<li>Rastreabilidad del material en las superficies de contacto con el producto de los productos de acero inoxidable SUS304 y SUS316L<\/li>\n<li>Prueba de aceptaci\u00f3n en f\u00e1brica \u2014rigor de la estanqueidad, flujo de aire, integridad del filtro y eficacia del VHP\u2014 antes del env\u00edo<\/li>\n<li>Instalaci\u00f3n y homologaci\u00f3n operativa in situ, conectada a servicios p\u00fablicos reales<\/li>\n<li>Calificaci\u00f3n de rendimiento que confirma resultados reproducibles en condiciones de proceso<\/li>\n<li>Paquete completo de documentaci\u00f3n: protocolos, informes de pruebas, certificados de materiales y manuales de operaci\u00f3n<\/li>\n<\/ul>\n<\/div>\n<\/section>\n<p><!-- credentials --><\/p>\n<section class=\"fg-sec\">\n<div class=\"fg-wrap fg-center\">\n  <span class=\"fg-tag\">Documentos de la empresa<\/span><\/p>\n<h2>Documentos de identidad de la empresa registrada<\/h2>\n<p class=\"fg-lead\">Shanghai Fenggu Medical Equipment Co., Ltd. cuenta con las siguientes acreditaciones empresariales. Las certificaciones a nivel de producto (ISO 9001, CE) se emiten seg\u00fan la configuraci\u00f3n y est\u00e1n disponibles bajo petici\u00f3n para proyectos espec\u00edficos.<\/p>\n<div class=\"fg-certs\">\n    <a href=\"\/wp-content\/uploads\/site\/cert1.jpg\" target=\"_blank\" rel=\"noopener\"><img width=\"300\" height=\"424\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cert1.jpg\" alt=\"Credenciales de la empresa Fenggu\"><\/a><br \/>\n    <a href=\"\/wp-content\/uploads\/site\/cert2.jpg\" target=\"_blank\" rel=\"noopener\"><img width=\"300\" height=\"424\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cert2.jpg\" alt=\"Credenciales de la empresa Fenggu\"><\/a><br \/>\n    <a href=\"\/wp-content\/uploads\/site\/cert3.jpg\" target=\"_blank\" rel=\"noopener\"><img width=\"300\" height=\"424\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cert3.jpg\" alt=\"Credenciales de la empresa Fenggu\"><\/a><br \/>\n    <a href=\"\/wp-content\/uploads\/site\/cert4.jpg\" target=\"_blank\" rel=\"noopener\"><img width=\"300\" height=\"424\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cert4.jpg\" alt=\"Credenciales de la empresa Fenggu\"><\/a><br \/>\n    <a href=\"\/wp-content\/uploads\/site\/cert5.jpg\" target=\"_blank\" rel=\"noopener\"><img width=\"300\" height=\"424\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cert5.jpg\" alt=\"Credenciales de la empresa Fenggu\"><\/a><br \/>\n    <a href=\"\/wp-content\/uploads\/site\/cert6.jpg\" target=\"_blank\" rel=\"noopener\"><img width=\"300\" height=\"424\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cert6.jpg\" alt=\"Credenciales de la empresa Fenggu\"><\/a>\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-full fg-cta fg-sec\">\n<div class=\"fg-wrap\">\n<h2>\u00bfNecesita documentaci\u00f3n para su archivo de validaci\u00f3n?<\/h2>\n<p>Proporcionamos protocolos de calificaci\u00f3n, informes de pruebas y documentaci\u00f3n de conformidad adaptados a su proyecto y al marco regulatorio.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/es\/contact\/\">Solicite documentaci\u00f3n<\/a><br \/>\n  <a class=\"fg-btn fg-btn-o\" href=\"\/es\/inspection-testing\/\">Inspecci\u00f3n y ensayos<\/a>\n<\/div>\n<\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Home &rsaquo; Quality &amp; Compliance Quality &amp; Compliance Built and Documented for Regulated Manufacturing Our equipment is designed, manufactured and [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-11","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/11","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/types\/page"}],"replies":[{"embeddable":true,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/comments?post=11"}],"version-history":[{"count":1,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/11\/revisions"}],"predecessor-version":[{"id":54,"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/pages\/11\/revisions\/54"}],"wp:attachment":[{"href":"https:\/\/fenggu-bio.com\/es\/wp-json\/wp\/v2\/media?parent=11"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}