{"id":208,"date":"2024-02-27T19:53:28","date_gmt":"2024-02-27T22:53:28","guid":{"rendered":"https:\/\/sitemakers.com.br\/bm\/?page_id=208"},"modified":"2024-03-05T06:27:27","modified_gmt":"2024-03-05T09:27:27","slug":"quality-system-regulation-21-cfr-part-820","status":"publish","type":"page","link":"https:\/\/sitemakers.com.br\/bm\/index.php\/qm-systems\/quality-system-regulation-21-cfr-part-820\/","title":{"rendered":"Quality System Regulation &#8211; 21 CFR Part 820"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"208\" class=\"elementor elementor-208\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed4858d e-con-full e-flex e-con e-parent\" data-id=\"ed4858d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2500e8a elementor-invisible elementor-widget elementor-widget-image\" data-id=\"2500e8a\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1720\" height=\"300\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages.jpg\" class=\"attachment-full size-full wp-image-186\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages.jpg 1720w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-300x52.jpg 300w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-1024x179.jpg 1024w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-768x134.jpg 768w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/02\/banner-pages-1536x268.jpg 1536w\" sizes=\"(max-width: 1720px) 100vw, 1720px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-68894a7 e-flex e-con-boxed elementor-invisible e-con e-parent\" data-id=\"68894a7\" data-element_type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;fadeInDown&quot;,&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c73e16b elementor-widget elementor-widget-heading\" data-id=\"c73e16b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Quality System Regulation - 21 CFR Part 820 <\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a9fbb9c e-flex e-con-boxed e-con e-parent\" data-id=\"a9fbb9c\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-10a837d e-con-full e-flex e-con e-child\" data-id=\"10a837d\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;full&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7902328 animated-slow elementor-invisible elementor-widget elementor-widget-text-editor\" data-id=\"7902328\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInLeft&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>Die QSR (Quality System Regulation) findet haupts\u00e4chlich in den USA Anwendung. Sie ist ein Gesetz \u2013 ihre Anwendung ist also verpflichtend. Die QSR (21CFR820) werden j\u00e4hrlich neu ver\u00f6ffentlicht. Eine heute oft verwendete \u00e4quivalente Bezeichnung ist cGMP (current Good Manufacturing Practices).\u00a0<\/p><p>Vom Inhalt her ist sie vergleichbar mit der Norm ISO 13485. Aspekte der Risikomanagement-Norm ISO 14971 sind nicht integriert, werden aber von FDA (Food &amp; Drug Administration) als \u201crecognized standard\u201d akzeptiert\/erwartet.\u00a0<\/p><p>F\u00fcr Produkte der Klassen II und III ist die QSR in der Regel verbindlich anzuwenden. In der QSR gibt es eine klare Definition von Dokumentengruppen wie z.B.<\/p><p>DHF = Design History File<\/p><p>DMR = Device Master Record<\/p><p>DHR = Device History Record<\/p><p>Wir helfen Ihnen bei der Umsetzung der Anforderungen der 21CFR820!<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8657ec9 animated-slow elementor-invisible elementor-widget elementor-widget-image\" data-id=\"8657ec9\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInRight&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"700\" height=\"465\" src=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/quality-system-regulation.jpg\" class=\"attachment-large size-large wp-image-321\" alt=\"\" srcset=\"https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/quality-system-regulation.jpg 700w, https:\/\/sitemakers.com.br\/bm\/wp-content\/uploads\/2024\/03\/quality-system-regulation-300x199.jpg 300w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ea8728a e-flex e-con-boxed e-con e-parent\" data-id=\"ea8728a\" data-element_type=\"container\" data-settings=\"{&quot;content_width&quot;:&quot;boxed&quot;}\" data-core-v316-plus=\"true\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9b3b1db elementor-widget elementor-widget-spacer\" data-id=\"9b3b1db\" data-element_type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.18.0 - 20-12-2023 *\/\n.elementor-column .elementor-spacer-inner{height:var(--spacer-size)}.e-con{--container-widget-width:100%}.e-con-inner>.elementor-widget-spacer,.e-con>.elementor-widget-spacer{width:var(--container-widget-width,var(--spacer-size));--align-self:var(--container-widget-align-self,initial);--flex-shrink:0}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container,.e-con>.elementor-widget-spacer>.elementor-widget-container{height:100%;width:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer{height:100%}.e-con-inner>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner,.e-con>.elementor-widget-spacer>.elementor-widget-container>.elementor-spacer>.elementor-spacer-inner{height:var(--container-widget-height,var(--spacer-size))}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty,.e-con>.elementor-widget-spacer.elementor-widget-empty{position:relative;min-height:22px;min-width:22px}.e-con-inner>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon,.e-con>.elementor-widget-spacer.elementor-widget-empty .elementor-widget-empty-icon{position:absolute;top:0;bottom:0;left:0;right:0;margin:auto;padding:0;width:22px;height:22px}<\/style>\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Quality System Regulation &#8211; 21 CFR Part 820 Die QSR (Quality System Regulation) findet haupts\u00e4chlich in den USA Anwendung. Sie ist ein Gesetz \u2013 ihre Anwendung ist also verpflichtend. Die QSR (21CFR820) werden j\u00e4hrlich neu ver\u00f6ffentlicht. Eine heute oft verwendete \u00e4quivalente Bezeichnung ist cGMP (current Good Manufacturing Practices).\u00a0 Vom Inhalt her ist sie vergleichbar mit [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":23,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-208","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/208","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/comments?post=208"}],"version-history":[{"count":10,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/208\/revisions"}],"predecessor-version":[{"id":324,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/208\/revisions\/324"}],"up":[{"embeddable":true,"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/pages\/23"}],"wp:attachment":[{"href":"https:\/\/sitemakers.com.br\/bm\/index.php\/wp-json\/wp\/v2\/media?parent=208"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}