{"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\/fr\/quality-compliance\/","title":{"rendered":"Qualit\u00e9 et conformit\u00e9"},"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=\"\/fr\/\">Accueil<\/a> \u203a Qualit\u00e9 et conformit\u00e9<\/div>\n<p>  <span class=\"fg-eyebrow\">Qualit\u00e9 et conformit\u00e9<\/span><\/p>\n<h1>Con\u00e7u et document\u00e9 pour une fabrication r\u00e9glement\u00e9e<\/h1>\n<p>Nos \u00e9quipements sont con\u00e7us, fabriqu\u00e9s et valid\u00e9s selon les normes auxquelles les fabricants de produits pharmaceutiques et de sciences de la vie sont soumis \u2014 ils s\u2019int\u00e8grent donc dans votre syst\u00e8me de qualit\u00e9, et non en dehors de celui-ci.<\/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\">Alignement des normes et r\u00e9glementation<\/span><\/p>\n<h2>Con\u00e7ue selon les normes attendues par vos auditeurs<\/h2>\n<div class=\"fg-std\">\n<div class=\"s\"><b>cGMP<\/b><span>Les bonnes pratiques de fabrication actuelles constituent la base de toutes les d\u00e9cisions de conception et de construction.<\/span><\/div>\n<div class=\"s\"><b>FDA 21 CFR, partie 11<\/b><span>Les enregistrements et signatures \u00e9lectroniques \u2014 traces d\u2019audit, contr\u00f4le d\u2019acc\u00e8s et int\u00e9grit\u00e9 des donn\u00e9es dans nos syst\u00e8mes de contr\u00f4le.<\/span><\/div>\n<div class=\"s\"><b>Annexe 1 des BPF de l'UE<\/b><span>Fabrication de produits m\u00e9dicinaux st\u00e9riles \u2014 conception de dispositifs de barri\u00e8re, de contr\u00f4le de l\u2019air et de contamination.<\/span><\/div>\n<div class=\"s\"><b>ISO 14644<\/b><span>Classification et essais de la puret\u00e9 de l\u2019air dans les salles blanches (conformit\u00e9 \u00e0 la norme ISO 5 \/ niveau A).<\/span><\/div>\n<div class=\"s\"><b>ISO 10648-2<\/b><span>Classification de l\u2019\u00e9tanch\u00e9it\u00e9 des enceintes de confinement pour les isolateurs et les \u00e9quipements herm\u00e9tiques.<\/span><\/div>\n<div class=\"s\"><b>USP 1208<\/b><span>Test d\u2019ins\u00e9mination dans les syst\u00e8mes d\u2019isolement \u2014 efficacit\u00e9 valid\u00e9e de la d\u00e9contamination par 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\">Notre approche qualit\u00e9<\/span><\/p>\n<h2>La qualit\u00e9 est v\u00e9rifi\u00e9e \u00e0 chaque \u00e9tape, pas seulement \u00e0 la fin.<\/h2>\n<ul class=\"fg-tlist\">\n<li>Qualification de la conception en fonction des exigences de l\u2019utilisateur et des crit\u00e8res cGMP avant le d\u00e9but de la fabrication<\/li>\n<li>R\u00e9troliaibilit\u00e9 du mat\u00e9riau pour les surfaces de contact avec les produits en SUS304 \/ SUS316L<\/li>\n<li>Test d\u2019acceptation de l\u2019usine \u2014 \u00e9tanch\u00e9it\u00e9 aux fuites, d\u00e9bit d\u2019air, int\u00e9grit\u00e9 du filtre et efficacit\u00e9 du VHP \u2014 avant l\u2019exp\u00e9dition<\/li>\n<li>Installation et qualification op\u00e9rationnelle sur site, connect\u00e9e aux r\u00e9seaux d\u2019alimentation \u00e9lectrique r\u00e9els<\/li>\n<li>Qualification de performance confirmant des r\u00e9sultats reproductibles dans des conditions de processus<\/li>\n<li>Pachet de documentation complet : protocoles, rapports d\u2019essai, certificats de conformit\u00e9 et manuels d\u2019utilisation<\/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\">Documents d'identit\u00e9 de l'entreprise<\/span><\/p>\n<h2>Identit\u00e9s d\u2019entreprise enregistr\u00e9es<\/h2>\n<p class=\"fg-lead\">Shanghai Fenggu Medical Equipment Co., Ltd. d\u00e9tient les certifications suivantes en tant qu\u2019entreprise : les certifications au niveau des produits (ISO 9001, CE) sont d\u00e9livr\u00e9es selon les configurations et sont disponibles sur demande pour des projets sp\u00e9cifiques.<\/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=\"Certificat d&#039;entreprise 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=\"Certificat d&#039;entreprise 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=\"Certificat d&#039;entreprise 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=\"Certificat d&#039;entreprise 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=\"Certificat d&#039;entreprise 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=\"Certificat d&#039;entreprise Fenggu\"><\/a>\n  <\/div>\n<\/div>\n<\/section>\n<section class=\"fg-full fg-cta fg-sec\">\n<div class=\"fg-wrap\">\n<h2>Avez-vous besoin de documentation pour votre fichier de validation ?<\/h2>\n<p>Nous fournissons des protocoles de qualification, des rapports d\u2019essai et des documents de conformit\u00e9 adapt\u00e9s \u00e0 votre projet et \u00e0 votre cadre r\u00e9glementaire.<\/p>\n<p>  <a class=\"fg-btn fg-btn-p\" href=\"\/fr\/contact\/\">Demander des documents<\/a><br \/>\n  <a class=\"fg-btn fg-btn-o\" href=\"\/fr\/inspection-testing\/\">Inspection et essais<\/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 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