{"id":12592,"date":"2016-08-22T11:57:31","date_gmt":"2016-08-22T11:57:31","guid":{"rendered":"https:\/\/www.bpa-solutions.net\/?p=12592"},"modified":"2023-05-09T04:43:19","modified_gmt":"2023-05-09T04:43:19","slug":"cfr-21-teil-11","status":"publish","type":"post","link":"https:\/\/www.bpa-solutions.net\/de\/cfr-21-part-11\/","title":{"rendered":"CFR 21 Teil 11 Compliance und elektronische Signatur"},"content":{"rendered":"<p>Titel 21 CFR Teil 11 ist der Teil von Titel 21 des Code of Federal Regulations, der die Vorschriften der US-amerikanischen FDA zu elektronischen Aufzeichnungen und elektronischen Signaturen festlegt. Teil 11 definiert die Kriterien, unter denen elektronische Aufzeichnungen und elektronische Signaturen als vertrauensw\u00fcrdig, zuverl\u00e4ssig und Papieraufzeichnungen gleichwertig angesehen werden.<\/p>\n<p>In diesem Artikel pr\u00e4sentieren wir einen einfachen Anwendungsfall zur Konfiguration eines Systems f\u00fcr die Compliance gem\u00e4\u00df 21 CFR Part 11.<\/p>\n<p>Um die in der Teil-11-Dokumentation genannte \u201cSigning Signature\u201d (Signatur) zu handhaben, sind einige Abweichungen von BPA Quality und SharePoint erforderlich. Die erste ist ein benutzerdefiniertes Feld f\u00fcr eine elektronische Signatur zur Erfassung des Benutzernamens und des Passworts, und die zweite ist ein Workflow, der die Dokumentengenehmigung von Anfang bis Ende abwickelt.<\/p>\n<p>Microsoft- und SharePoint-Technologien bieten viele Tools f\u00fcr die Einhaltung gesetzlicher Vorschriften, wie Active-Directory-Dienste, SQL-Server-Datenbank- und BI-Dienste, Berechtigungseinstellungen f\u00fcr SharePoint-Listen und -Bibliotheken sowie Versions- und Audit-Einstellungen.<\/p>\n<p>In diesem typischen Anwendungsfall haben Dokumentenmanager (Redakteure, Genehmigende, Verteiler) Bearbeiterrechte f\u00fcr die Dokumentenbibliothek. Genehmigte Dokumente werden in einer anderen Bibliothek oder Website (z. B. im Unternehmens-Intranet) ver\u00f6ffentlicht, auf der Endbenutzer Leserechte haben.<\/p>\n<div id=\"attachment_12593\" style=\"width: 790px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-12593\" class=\"size-full wp-image-12593\" src=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-approval-workflow.png\" alt=\"Dokumentenfreigabe-Workflow\" width=\"780\" height=\"521\" srcset=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-approval-workflow.png 780w, https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-approval-workflow-480x321.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 780px, 100vw\" \/><p id=\"caption-attachment-12593\" class=\"wp-caption-text\">Beispiel f\u00fcr einen grafischen Dokumentenfreigabe-Workflow.<\/p><\/div>\n<p>Das E-Signatur-Modul speichert die Benutzeridentit\u00e4t sowie Datum und Uhrzeit der Signierung in verschl\u00fcsselter Form. Dies stellt sicher, dass nur befugte Personen ein Dokument, Dokumenteneigenschaften oder Qualit\u00e4tsdatens\u00e4tze \u00e4ndern k\u00f6nnen. Jedes Mal, wenn Dokumente, Dokumenteneigenschaften oder Qualit\u00e4tsdatens\u00e4tze ge\u00e4ndert werden, ist eine E-Signatur erforderlich. Ohne eine g\u00fcltige Signatur ist im Dokument oder in den Datensatz-Eigenschaften ein roter Stempel sichtbar.<\/p>\n<div id=\"attachment_12594\" style=\"width: 678px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-12594\" class=\"size-full wp-image-12594\" src=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-properties.png\" alt=\"Dokumenteigenschaften\" width=\"668\" height=\"450\" srcset=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-properties.png 668w, https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-properties-480x323.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 668px, 100vw\" \/><p id=\"caption-attachment-12594\" class=\"wp-caption-text\">Das benutzerdefinierte Feld f\u00fcr die elektronische Signatur in den Dokumenteigenschaften stellt sicher, dass das Dokument vor der Ver\u00f6ffentlichung von den richtigen Personen genehmigt wurde.<\/p><\/div>\n<p>Mit BPA Quality k\u00f6nnen Endbenutzer problemlos \u00fcber ein Organigramm oder eine Prozesslandkarte auf ver\u00f6ffentlichte Dokumente zugreifen.<\/p>\n<div id=\"attachment_12595\" style=\"width: 670px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-12595\" class=\"size-full wp-image-12595\" src=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Process-map.png\" alt=\"Prozessplan\" width=\"660\" height=\"441\" srcset=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Process-map.png 660w, https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Process-map-480x321.png 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 660px, 100vw\" \/><p id=\"caption-attachment-12595\" class=\"wp-caption-text\">Die Prozesslandkarte ist die ideale Einstiegsseite f\u00fcr Endbenutzer, um auf ver\u00f6ffentlichte Dokumente f\u00fcr die verschiedenen Prozesse zuzugreifen.<\/p><\/div>","protected":false},"excerpt":{"rendered":"<p>Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States FDA regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. In this article we [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":12596,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","inline_featured_image":false,"footnotes":""},"categories":[64,58,83],"tags":[],"class_list":["post-12592","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bpa-solutions","category-news-about","category-quality-products"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CFR 21 Part 11 Compliance &amp; Electronic Signature - BPA Solutions<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bpa-solutions.net\/de\/cfr-21-teil-11\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CFR 21 Part 11 Compliance &amp; Electronic Signature - BPA Solutions\" \/>\n<meta property=\"og:description\" content=\"Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States FDA regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. In this article we [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.bpa-solutions.net\/de\/cfr-21-teil-11\/\" \/>\n<meta property=\"og:site_name\" content=\"BPA Solutions\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/BPASolutions?fref=ts\" \/>\n<meta property=\"article:published_time\" content=\"2016-08-22T11:57:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-05-09T04:43:19+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2016\/08\/Document-approval-workflow.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"779\" \/>\n\t<meta property=\"og:image:height\" content=\"251\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Boris Lutz\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@BPA_SOLUTIONS\" \/>\n<meta name=\"twitter:site\" content=\"@BPA_SOLUTIONS\" \/>\n<meta name=\"twitter:label1\" content=\"Verfasst von\" \/>\n\t<meta name=\"twitter:data1\" content=\"Boris Lutz\" \/>\n\t<meta name=\"twitter:label2\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.bpa-solutions.net\\\/cfr-21-part-11\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.bpa-solutions.net\\\/cfr-21-part-11\\\/\"},\"author\":{\"name\":\"Boris Lutz\",\"@id\":\"https:\\\/\\\/www.bpa-solutions.net\\\/#\\\/schema\\\/person\\\/1752d1ec96e94ebb1316bd53a2bd57ae\"},\"headline\":\"CFR 21 Part 11 Compliance &#038; 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