{"id":25919,"date":"2023-09-12T16:14:21","date_gmt":"2023-09-12T14:14:21","guid":{"rendered":"https:\/\/staging.praxas.com\/product\/unkategorisiert\/el-wifi-21cfr-ult\/"},"modified":"2025-10-09T10:00:43","modified_gmt":"2025-10-09T08:00:43","slug":"el-wifi-21cfr-ult","status":"publish","type":"product","link":"https:\/\/praxas.com\/de\/product\/datenlogger\/temperatur-datenlogger\/el-wifi-21cfr-ult\/","title":{"rendered":"EL-WiFi-21CFR-ULT"},"content":{"rendered":"<p>Der EL-WiFi-21CFR-ULT ist ein 21CFR Part 11-kompatibler, kabelloser Ultratieftemperatur-Datenlogger mit integriertem Display, der f\u00fcr die \u00dcberwachung von Impfstoffen in Trockeneislagern bei ultratiefen Temperaturen entwickelt wurde. Der Messbereich betr\u00e4gt -100 bis +100\u00b0C (-148 bis +212\u00b0F) bei Verwendung der mit dem Logger gelieferten Sonde. Der Logger zeichnet automatisch Daten auf und l\u00e4dt sie in die <strong><br \/>\n  <a href=\"https:\/\/21cfr.wifisensorcloud.com\/\" target=\"_blank\" rel=\"noopener\">EasyLog 21CFR Cloud<\/a><br \/>\n<\/strong> \u00fcber Ihr drahtloses Standardnetzwerk. Das Ger\u00e4t speichert Daten intern, wenn es die WiFi-Verbindung verliert, und l\u00e4dt sie automatisch in die Cloud hoch, sobald es wieder verbunden ist.<\/p>\n<p><strong>Warum einen 21CFR-Logger kaufen?<\/strong><br \/>\nDie von der US Food and Drug Administration (FDA) erlassenen Vorschriften 21 CFR Part 11 enthalten die Kriterien, nach denen elektronische Aufzeichnungen von der FDA als gleichwertig mit signierten Papieraufzeichnungen angesehen werden k\u00f6nnen. Wenn Sie diese Vorschriften einhalten m\u00fcssen oder erh\u00f6hte Anforderungen an die Datensicherheit haben, sollten Sie sich f\u00fcr einen unserer 21CFR-Logger entscheiden, ansonsten reichen unsere Standard-Logger aus.<\/p>\n<p>Ein 21CFR Cloud-Abonnement bietet die gesamte Flexibilit\u00e4t der Fern\u00fcberwachung und kann als Teil eines 21CFR-konformen Systems installiert werden. Zu den Funktionen geh\u00f6ren die erlaubnisbasierte Nutzung, die Freigabe auf Autorit\u00e4tsebene und eine vollst\u00e4ndige Systempr\u00fcfung, um sicherzustellen, dass die \u00fcberwachten und erfassten Daten dem Standard 21CFR Part 11 entsprechen. Dieses Ger\u00e4t erfordert ein Abonnement f\u00fcr unseren EasyLog 21CFR Cloud Service.<\/p>\n<p>Dieses Produkt entspricht der Norm BS EN 12830:2018 (Temperaturaufzeichnungsger\u00e4te f\u00fcr den Transport, die Lagerung und den Vertrieb temperaturempfindlicher Waren).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>21CFR-konformer WiFi-Datenlogger f\u00fcr kryogene Impfstoffe mit 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| Kryogener Impfstoff-Logger mit Display"],"rank_math_description":["Der EL-WIFI-21CFR-ULT ist ein Cloud-f\u00e4higer, drahtloser Datenlogger mit integriertem Display zur \u00dcberwachung von Impfstoffen bei der Lagerung und dem Transport von Trockeneis bei extrem niedrigen Temperaturen."],"rank_math_focus_keyword":["EL-WiFi-21CFR-ULT"],"specifications_table":["<table class=\"specifications\">\n<tbody>\n<tr class=\"even-row\">\n<td class=\"left-td\">Messbereich<\/td>\n<td>-100 bis +100\u00b0C (-148 bis +212\u00b0F)<\/td>\n<\/tr>\n<tr class=\"odd-row\">\n<td class=\"left-td\">Genauigkeit<\/td>\n<td>\u00b12,5\u00b0C (\u00b14,5\u00b0F) typisch<\/td>\n<\/tr>\n<tr class=\"even-row\">\n<td class=\"left-td\">Logging-Rate<\/td>\n<td>Vom Benutzer w\u00e4hlbar zwischen 10 Sekunden und 12 Stunden<\/td>\n<\/tr>\n<tr class=\"odd-row\">\n<td class=\"left-td\">Speicherkapazit\u00e4t<\/td>\n<td>Unbegrenzt<\/td>\n<\/tr>\n<tr class=\"even-row\">\n<td class=\"left-td\">Abmessungen (Logger)<\/td>\n<td>82 x 70 x 23mm (3.22 x 2.75 x 0.91\")<\/td>\n<\/tr>\n<tr class=\"odd-row\">\n<td class=\"left-td\">Abmessungen (Sonde)<\/td>\n<td>300 x \u00d81,5mm x 1m Kabel (11,8 x \u00d80,06\" x 39,4\" Kabel)<\/td>\n<\/tr>\n<tr class=\"even-row\">\n<td class=\"left-td\">Batterie<\/td>\n<td>Wiederaufladbare Batterie \/ 6 Monate Batterielebensdauer \/ Option Netzbetrieb<\/td>\n<\/tr>\n<\/tbody>\n<\/table>"],"resources":["<ul class=\"resources-list\">\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Dokument-Symbol\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/el-wifi-21cfr-ult_iss1_11-20-1.pdf\" target=\"_blank\" rel=\"noopener\"><span class=\"mldTitle\">EL-WiFi-21CFR-ULT Datenblatt<\/span><\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/software-icon.png\" alt=\"Software-Symbol\"><a href=\"\/software\/easylog-software\/easylog-21cfr-wifi\/\" target=\"_blank\" rel=\"noopener\">EasyLog 21CFR WiFi<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Dokument-Symbol\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/el_21cfr_wifi_qsg_iss2_04-19.pdf\" target=\"_blank\" rel=\"noopener\">EL-21CFR-WiFi Schnellstartanleitung<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Dokument-Symbol\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/help-guide-3-network-requirements-and-settings-12-09-2022_issue-6.pdf\" target=\"_blank\" rel=\"noopener\">Netzwerkanforderungen und -einstellungen<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Dokument-Symbol\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/conformity_certificate_wifi_range_with_coo-issu8.pdf\" target=\"_blank\" rel=\"noopener\">EL-WiFi-21CFR Konformit\u00e4tserkl\u00e4rung<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Dokument-Symbol\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/bs-en-12830-record-of-compliance-issue-1.pdf\" target=\"_blank\" rel=\"noopener\">BS EN 12830:2018 Nachweis der Einhaltung<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Dokument-Symbol\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/21cfr-requirements-checklist_issue_3-04_2020-wifi.pdf\" target=\"_blank\" rel=\"noopener\">21CFR Anforderungen Checkliste<\/a><\/li>\n<\/ul>\n<a class=\"button button-secondary\" href=\"https:\/\/praxas.com\/support\/\">Mehr Unterst\u00fctzung<\/a>"],"accessories":["[products skus=\"EL-P-TC-T-ULT,PSU USB-UK,PSU USB-EU,EL-WiFi Wall Bracket\"]"],"faqs":["<span class=\"ui-provider bge bgf bgd bgg bgh bgi bgj bgk bgl bgm bgn bgo bgp bgq bgr bgs bgt bgu bgv bgw bgx bgy bgz bha bhb bhc bhd bhe bhf bhg bhh bhi bhj bhk bhl\" dir=\"ltr\">[accordion]\n[accordion_header]K\u00f6nnten Sie erkl\u00e4ren, was 21 CFR Teil 11 ist?[\/accordion_header]\n[accordion_section]Der Code of Federal Regulations 21 Part 11 der US FDA (Food & Drugs Administration) ist eine Erweiterung der bestehenden Vorschriften, in denen definiert wird, welche elektronischen Aufzeichnungen und Signaturen als korrekt anzusehen sind, um Papieraufzeichnungen in der pharmazeutischen und medizinischen Industrie zu ersetzen. Unser System wurde entwickelt, um Unternehmen bei der Einhaltung dieser Vorschriften zu unterst\u00fctzen.[\/accordion_section]\n[\/accordion]<\/span>\n\n<span class=\"ui-provider bge bgf bgd bgg bgh bgi bgj bgk bgl bgm bgn bgo bgp bgq bgr bgs bgt bgu bgv bgw bgx bgy bgz bha bhb bhc bhd bhe bhf bhg bhh bhi bhj bhk bhl\" dir=\"ltr\">[accordion]\n[accordion_header]W\u00e4re das Produkt 21CFR Cloud f\u00fcr mein Unternehmen geeignet?[\/accordion_header]\n[accordion_section]Das Produkt wurde f\u00fcr Unternehmen entwickelt, die ihre Papieraufzeichnungen sicher durch elektronische Mittel ersetzen m\u00f6chten, um die Bestimmungen von 21 CFR Part 11 f\u00fcr die pharmazeutische und medizinische Industrie zu erf\u00fcllen. 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