{"id":2826,"date":"2023-05-15T16:57:33","date_gmt":"2023-05-15T15:57:33","guid":{"rendered":"https:\/\/vosfoxmedical.com\/validation\/validation-du-processus\/"},"modified":"2024-10-09T13:01:49","modified_gmt":"2024-10-09T12:01:49","slug":"validation-du-processus","status":"publish","type":"page","link":"https:\/\/vosfoxmedical.com\/fr\/services-2\/validation\/validation-du-processus\/","title":{"rendered":"Validation du processus"},"content":{"rendered":"\t<section class=\"section dark\" id=\"section_1599783918\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t<div class=\"section-bg-overlay absolute fill\"><\/div>\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\" style=\"max-width:1300px\" id=\"row-226252604\">\n\n\t<div id=\"col-1023537462\" class=\"col medium-12 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-2982564891\" class=\"text\">\n\t\t\n<h1 class=\"entry-title\"><span style=\"font-size: 100%;\">Validation du processus<\/span><\/h1>\n\t\t\n<style>\n#text-2982564891 {\n  font-size: 2.75rem;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1599783918 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  min-height: 400px;\n  background-color: #5a0958;\n}\n#section_1599783918 .section-bg-overlay {\n  background-color: rgba(90, 9, 88, 0.89);\n}\n#section_1599783918 .section-bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/img-thunderstorm.jpg);\n}\n#section_1599783918 .section-bg {\n  background-position: 90% 59%;\n}\n#section_1599783918 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1599783918 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_1599783918 {\n    min-height: 400px;\n  }\n}\n@media (min-width:850px) {\n  #section_1599783918 {\n    min-height: 600px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n<div class=\"row align-bottom\" style=\"max-width:1300px\" id=\"row-1088256993\">\n\n\t<div id=\"col-667514371\" class=\"col medium-12 small-12 large-8 medium-col-first\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-555769788\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-555769788 {\n  padding-top: 300px;\n  background-color: rgb(255,255,255);\n}\n#banner-555769788 .bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-iqoqpq.jpg);\n}\n#banner-555769788 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-555769788 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #banner-555769788 {\n    padding-top: 600px;\n  }\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-667514371 > .col-inner {\n  margin: -120px 0px 0px 0px;\n}\n@media (min-width:550px) {\n  #col-667514371 > .col-inner {\n    margin: -120px 0px 0px 0px;\n  }\n}\n@media (min-width:850px) {\n  #col-667514371 > .col-inner {\n    margin: -500px 0px 0px 0px;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<section class=\"section\" id=\"section_875872781\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row row-large align-equal align-right\"  id=\"row-426332705\">\n\n\t<div id=\"col-1069264789\" class=\"col medium-12 small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p class=\"lead\">La validation des processus est n\u00e9cessaire lorsque la qualit\u00e9 d&rsquo;un produit ne peut \u00eatre v\u00e9rifi\u00e9e \u00e0 100 % (en raison d&rsquo;un trop grand nombre de produits ou d&rsquo;essais destructifs).<br \/>\nLa validation du processus se compose de trois \u00e9tapes : Qualification de l&rsquo;installation (QI), Qualification op\u00e9rationnelle (QO) et Qualification des performances (QP).<br \/>\nVous trouverez des informations plus d\u00e9taill\u00e9es sur la validation en g\u00e9n\u00e9ral dans <a href=\"https:\/\/vosfoxmedical.com\/vosfoxmedical\/articles\/process-validation\/\"><strong>cet article<\/strong><\/a>ou sur la validation ax\u00e9e sur l&rsquo;impression 3D m\u00e9dicale dans <a href=\"https:\/\/vosfoxmedical.com\/vosfoxmedical\/articles\/validation-3d-printing-process\/\"><strong>cet article<\/strong><\/a>.  <\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row row-small\"  id=\"row-1614204940\">\n\n\t<div id=\"col-696235756\" class=\"col medium-6 small-11 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1563221537\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-704939737\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-704939737 {\n  width: 60%;\n}\n#text-box-704939737 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1563221537 {\n  padding-top: 454px;\n}\n#banner-1563221537 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-iq.jpg?fit=492%2C512&ssl=1);\n}\n#banner-1563221537 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1563221537 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-696235756 > .col-inner {\n  padding: 0px 0px 0px 0;\n}\n@media (min-width:550px) {\n  #col-696235756 > .col-inner {\n    padding: 0px 0px 0px 0;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-889037814\" class=\"col medium-6 small-11 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Qualification de l&rsquo;installation<\/h2>\n<p>Chez Vosfox Medical, nous combinons les \u00e9tapes de qualification de l&rsquo;installation et de validation de l&rsquo;\u00e9quipement et du processus.<br \/>\nLors de la qualification de l&rsquo;installation, nous v\u00e9rifions les points suivants : <\/p>\n<ul>\n<li>Pr\u00e9sence d&rsquo;\u00e9quipements de travail, d&rsquo;utilitaires, d&rsquo;outils, de pi\u00e8ces de rechange, d&rsquo;instructions, de manuels, de dessins, etc.<\/li>\n<li>Incorporation de l&rsquo;\u00e9quipement dans les proc\u00e9dures de contr\u00f4le de l&rsquo;\u00e9quipement (par exemple, maintenance, \u00e9talonnage, nettoyage)<\/li>\n<li>Validation des logiciels et des microprogrammes<\/li>\n<li>Tests de s\u00e9curit\u00e9<\/li>\n<li>Tests de fonctionnalit\u00e9 de base<\/li>\n<\/ul>\n<p>Nous travaillons avec des cas de test pour v\u00e9rifier que toutes les \u00e9tapes de test requises sont effectu\u00e9es, et cela standardise une partie du travail pour am\u00e9liorer la vitesse et r\u00e9duire les co\u00fbts.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-889037814 > .col-inner {\n  padding: 0px 0px 0px 0;\n}\n@media (min-width:550px) {\n  #col-889037814 > .col-inner {\n    padding: 0px 0px 0px 0;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-1487786971\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1487786971 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-2050254217\">\n\n\t<div id=\"col-873295328\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Qualification op\u00e9rationnelle<\/h2>\n<p>Au cours de la qualification op\u00e9rationnelle, les activit\u00e9s suivantes sont r\u00e9alis\u00e9es :<\/p>\n<ul>\n<li>D\u00e9veloppement de processus &#8211; d\u00e9finition d&rsquo;une fen\u00eatre de processus approximative.<br \/>\nLorsqu&rsquo;un processus est bien connu (par exemple, le scellage de sachets), la partie d\u00e9veloppement n&rsquo;existe pas ou se limite \u00e0 quelques tests. <\/li>\n<li>Conception de l&rsquo;exp\u00e9rience &#8211; d\u00e9terminer l&rsquo;interaction entre les diff\u00e9rents param\u00e8tres critiques du processus et fixer les valeurs minimales et maximales.<br \/>\nNous comparons les produits avec des sp\u00e9cifications (provisoires) pr\u00e9d\u00e9termin\u00e9es. <\/li>\n<li>La v\u00e9rification s&rsquo;effectue \u00e0 des r\u00e9glages faibles, nominaux et \u00e9lev\u00e9s.<br \/>\nCes tests nous donnent une certaine souplesse dans les r\u00e9glages du processus, sachant qu&rsquo;ils produisent des produits de bonne qualit\u00e9. <\/li>\n<\/ul>\n<p>En outre, un contr\u00f4le est effectu\u00e9 sur la mise en \u0153uvre des mesures d&rsquo;att\u00e9nuation des risques graves.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1928086461\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1154345607\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-1406932277\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-1406932277 {\n  width: 60%;\n}\n#text-box-1406932277 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1154345607 {\n  padding-top: 440px;\n}\n#banner-1154345607 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-oq.jpg?fit=486%2C470&ssl=1);\n}\n#banner-1154345607 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1154345607 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-349844196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-349844196 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-884912342\">\n\n\t<div id=\"col-395716661\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-862098131\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-1653900712\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-1653900712 {\n  width: 60%;\n}\n#text-box-1653900712 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-862098131 {\n  padding-top: 330px;\n}\n#banner-862098131 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-pq.jpg?fit=444%2C435&ssl=1);\n}\n#banner-862098131 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-862098131 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1906028885\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Qualification des performances<\/h2>\n<p>Au cours de la qualification des performances, des lots entiers de produits sont produits \u00e0 des r\u00e9glages nominaux.<br \/>\nToutes les instructions de travail, les validations des m\u00e9thodes d&rsquo;essai, la validation de la salle blanche, les sp\u00e9cifications, etc. sont finalis\u00e9es avant le d\u00e9but de la qualification des performances. <\/p>\n<p>Les lots produits pendant la QP peuvent, s&rsquo;ils r\u00e9pondent \u00e0 toutes les sp\u00e9cifications du produit, \u00eatre utilis\u00e9s dans des essais cliniques ou vendus dans le commerce.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-215499935\">\n\n\t<div id=\"col-2115352336\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-54869419\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/vosfoxmedical.com\/fr\/?page_id=2510\" target=\"_self\" class=\"button primary\"  >\n    <span>Page de pr\u00e9sentation de la validation des retours<\/span>\n  <\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_875872781 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_875872781 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_875872781 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_875872781 {\n    padding-top: 70px;\n    padding-bottom: 70px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":2510,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-2826","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.2 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Validation du processus | Sur la voie des produits cliniques<\/title>\n<meta name=\"description\" content=\"La validation du processus constitue une \u00e9tape sur la voie de la production de produits cliniques. Lorsqu&#039;une v\u00e9rification \u00e0 100 % n&#039;est pas possible, une validation est n\u00e9cessaire.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/vosfoxmedical.com\/fr\/services-2\/validation\/validation-du-processus\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validation du processus\" \/>\n<meta property=\"og:description\" content=\"La validation du processus constitue une \u00e9tape sur la voie de la production de produits cliniques. 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