{"id":75098,"date":"2025-11-18T18:04:55","date_gmt":"2025-11-18T18:04:55","guid":{"rendered":"https:\/\/v7.kapelanbio.com\/produkte\/labimage\/einhaltung-von-21-cfr-teil-11\/"},"modified":"2026-01-20T11:05:08","modified_gmt":"2026-01-20T11:05:08","slug":"konformitaet-mit-fda-21-cfr-teil-11","status":"publish","type":"page","link":"https:\/\/www.kapelanbio.com\/de\/produkte\/labimage-software\/konformitaet-mit-fda-21-cfr-teil-11\/","title":{"rendered":"Konformit\u00e4t mit FDA 21 CFR Teil 11"},"content":{"rendered":"<style>.elementor-75098 .elementor-element.elementor-element-aa1f2ac{--display:flex;--min-height:360px;--flex-direction:column;--container-widget-width:calc( ( 1 - var( --container-widget-flex-grow ) ) * 100% );--container-widget-height:initial;--container-widget-flex-grow:0;--container-widget-align-self:initial;--flex-wrap-mobile:wrap;--justify-content:center;--align-items:flex-start;}.elementor-75098 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.elementor-element.elementor-element-e21aa5f{--width:40%;}.elementor-75098 .elementor-element.elementor-element-4441f4b{--width:60%;}.elementor-75098 .elementor-element.elementor-element-1d436a7{--width:50%;}.elementor-75098 .elementor-element.elementor-element-78639e3{--width:40%;}.elementor-75098 .elementor-element.elementor-element-ee19acf{--width:60%;}}@media(max-width:1024px) and (min-width:768px){.elementor-75098 .elementor-element.elementor-element-5795e14{--width:511px;}.elementor-75098 .elementor-element.elementor-element-f31dc04{--width:100%;}.elementor-75098 .elementor-element.elementor-element-1d436a7{--width:100%;}}@media(min-width:1025px){.elementor-75098 .elementor-element.elementor-element-aa1f2ac:not(.elementor-motion-effects-element-type-background), .elementor-75098 .elementor-element.elementor-element-aa1f2ac > .elementor-motion-effects-container > .elementor-motion-effects-layer{background-attachment:scroll;}}<\/style>\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"75098\" class=\"elementor elementor-75098 elementor-74245\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aa1f2ac e-flex e-con-boxed e-con e-parent\" data-id=\"aa1f2ac\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-5795e14 e-con-full e-flex e-con e-child\" data-id=\"5795e14\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c991566 elementor-widget elementor-widget-heading\" data-id=\"c991566\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Konformit\u00e4t mit FDA 21 CFR Part 11\n<\/h1>\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-3009959 e-flex e-con-boxed e-con e-child\" data-id=\"3009959\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-d3513ce e-con-full e-flex e-con e-child\" data-id=\"d3513ce\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-64e1630 elementor-widget elementor-widget-heading\" data-id=\"64e1630\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">FDA-Konformit\u00e4t gem\u00e4\u00df 21 CFR Teil 11\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-be9ed42 elementor-widget elementor-widget-heading\" data-id=\"be9ed42\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Allgemeine Informationen zur Einhaltung von 21 CFR Part 11<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-038acb6 elementor-widget elementor-widget-text-editor\" data-id=\"038acb6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Die FDA (US-amerikanische Lebensmittel- und Arzneimittelbeh\u00f6rde) richtete in Zusammenarbeit mit Vertretern der betroffenen Branchen eine Arbeitsgruppe ein, um den Anwendungsbereich, die allgemeinen Anforderungen und die Implementierungsverfahren f\u00fcr elektronische Aufzeichnungen festzulegen, die die Beh\u00f6rde anstelle herk\u00f6mmlicher Papieraufzeichnungen akzeptieren w\u00fcrde. Im M\u00e4rz 1997 wurde die endg\u00fcltige Regelung zu elektronischen Aufzeichnungen, Signaturen und Einreichungen, bekannt als 21 CFR Part 11 (Code of Federal Regulations), unterzeichnet und ver\u00f6ffentlicht. <\/p><p>Da heute nahezu alle Routine-, Diagnose- und Qualit\u00e4tskontrolllabore den Vorschriften von 21 CFR Part 11 unterliegen, unterst\u00fctzt Kapelan Bio-Imaging die Werkzeuge f\u00fcr den technischen Teil der Softwarekonformit\u00e4t in den Laboren.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2c3b029 elementor-widget elementor-widget-button\" data-id=\"2c3b029\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/v7.kapelanbio.com\/de\/produkte\/labimage\/einhaltung-von-21-cfr-teil-11\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Mehr zur Einhaltung von 21 CFR Part 11<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b238233 e-con-full e-flex e-con e-child\" data-id=\"b238233\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d5d0ae9 elementor-widget elementor-widget-image\" data-id=\"d5d0ae9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"331\" height=\"284\" src=\"https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Bild1.png\" class=\"attachment-full size-full wp-image-75095\" alt=\"\" srcset=\"https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Bild1.png 331w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Bild1-300x257.png 300w\" sizes=\"(max-width: 331px) 100vw, 331px\" \/>\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-b77ee6f e-flex e-con-boxed e-con e-parent\" data-id=\"b77ee6f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f31dc04 e-con-full e-flex e-con e-child\" data-id=\"f31dc04\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-e21aa5f e-con-full e-flex e-con e-child\" data-id=\"e21aa5f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e19d7ee elementor-widget elementor-widget-image\" data-id=\"e19d7ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1826\" src=\"https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-scaled.jpg\" class=\"attachment-full size-full wp-image-75096\" alt=\"\" srcset=\"https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-scaled.jpg 2560w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-300x214.jpg 300w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-1024x730.jpg 1024w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-768x548.jpg 768w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-1536x1095.jpg 1536w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implement-2048x1461.jpg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\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<div class=\"elementor-element elementor-element-4441f4b e-con-full e-flex e-con e-child\" data-id=\"4441f4b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3109208 elementor-widget elementor-widget-heading\" data-id=\"3109208\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Wir zeigen Ihnen, wie wir die 21 CFR Part 11-Konformit\u00e4t in LabImage 1D implementiert haben. \n\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c634cf elementor-widget elementor-widget-text-editor\" data-id=\"1c634cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tWir zeigen Ihnen, wie wir die 21 CFR Part 11-Konformit\u00e4t in LabImage 1D implementiert haben.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dbdb7e8 elementor-widget elementor-widget-button\" data-id=\"dbdb7e8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"\/21-cfr-part-11-workflows\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">21 CFR Part 11 in LabImage 1D <\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\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-1d436a7 e-con-full e-flex e-con e-child\" data-id=\"1d436a7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-78639e3 e-con-full e-flex e-con e-child\" data-id=\"78639e3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ea49751 elementor-widget elementor-widget-image\" data-id=\"ea49751\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2000\" height=\"1667\" src=\"https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implementation-2-e1763491648794.jpg\" class=\"attachment-full size-full wp-image-75097\" alt=\"\" srcset=\"https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implementation-2-e1763491648794.jpg 2000w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implementation-2-e1763491648794-300x250.jpg 300w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implementation-2-e1763491648794-1024x854.jpg 1024w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implementation-2-e1763491648794-768x640.jpg 768w, https:\/\/www.kapelanbio.com\/wp-content\/uploads\/2025\/11\/Implementation-2-e1763491648794-1536x1280.jpg 1536w\" sizes=\"(max-width: 2000px) 100vw, 2000px\" \/>\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<div class=\"elementor-element elementor-element-ee19acf e-con-full e-flex e-con e-child\" data-id=\"ee19acf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0dc06e1 elementor-widget elementor-widget-heading\" data-id=\"0dc06e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Implementierung in unseren Anwendungen\n\n\n<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-916784e elementor-widget elementor-widget-text-editor\" data-id=\"916784e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>F\u00fcr jede 21 CFR Part 11-Lizenz liefert Kapelan eine detaillierte Antwort zur Einhaltung der Part 11-Vorschriften. Mithilfe dieses Dokuments k\u00f6nnen Kunden die Part 11-Konformit\u00e4t der Kapelan-Produkte nachvollziehen. <\/p>\t\t\t\t\t\t\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Konformit\u00e4t mit FDA 21 CFR Part 11 FDA-Konformit\u00e4t gem\u00e4\u00df 21 CFR Teil 11 Allgemeine Informationen zur Einhaltung von 21 CFR Part 11 Die FDA (US-amerikanische Lebensmittel- und Arzneimittelbeh\u00f6rde) richtete in Zusammenarbeit mit Vertretern der betroffenen Branchen eine Arbeitsgruppe ein, um den Anwendungsbereich, die allgemeinen Anforderungen und die Implementierungsverfahren f\u00fcr elektronische Aufzeichnungen festzulegen, die die Beh\u00f6rde [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":75087,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-75098","page","type-page","status-publish","hentry"],"blocksy_meta":[],"yoast_head":"<title>Konformit\u00e4t mit FDA 21 CFR Teil 11 - 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