{"id":30282,"date":"2023-09-12T16:14:21","date_gmt":"2023-09-12T14:14:21","guid":{"rendered":"https:\/\/staging.praxas.com\/product\/non%20class\u00e9\/el-wifi-21cfr-ult-2\/"},"modified":"2025-10-09T10:00:44","modified_gmt":"2025-10-09T08:00:44","slug":"el-wifi-21cfr-ult-2","status":"publish","type":"product","link":"https:\/\/praxas.com\/fr\/product\/data-loggers-fr\/enregistreurs-de-donnees-de-temperature\/el-wifi-21cfr-ult-2\/","title":{"rendered":"EL-WiFi-21CFR-ULT"},"content":{"rendered":"<p>Le EL-WiFi-21CFR-ULT est un enregistreur de donn\u00e9es sans fil \u00e0 ultra-basse temp\u00e9rature conforme \u00e0 la 21CFR Part 11, avec un \u00e9cran int\u00e9gr\u00e9, con\u00e7u pour surveiller les vaccins dans les entrep\u00f4ts de glace s\u00e8che \u00e0 ultra-basse temp\u00e9rature. La plage de mesure est de -100 \u00e0 +100\u00b0C (-148 \u00e0 +212\u00b0F) en utilisant la sonde fournie avec l&rsquo;enregistreur. L&rsquo;enregistreur enregistre automatiquement les donn\u00e9es et les t\u00e9l\u00e9charge vers le logiciel <strong><br \/>\n  <a href=\"https:\/\/21cfr.wifisensorcloud.com\/\" target=\"_blank\" rel=\"noopener\">EasyLog 21CFR Cloud<\/a><br \/>\n<\/strong> en utilisant votre r\u00e9seau sans fil standard. L&rsquo;appareil stocke les donn\u00e9es en interne s&rsquo;il perd la connexion WiFi et les t\u00e9l\u00e9charge automatiquement dans le nuage d\u00e8s qu&rsquo;il est reconnect\u00e9.<\/p>\n<p><strong>Pourquoi acheter un enregistreur 21CFR ?<\/strong><br \/>\nLa r\u00e9glementation 21 CFR Part 11 publi\u00e9e par la Food and Drug Administration (FDA) am\u00e9ricaine d\u00e9finit les crit\u00e8res selon lesquels les enregistrements \u00e9lectroniques peuvent \u00eatre consid\u00e9r\u00e9s par la FDA comme \u00e9quivalents aux enregistrements papier sign\u00e9s. Si vous devez respecter ces r\u00e9glementations ou si vous avez des exigences accrues en mati\u00e8re de s\u00e9curit\u00e9 des donn\u00e9es, choisissez l&rsquo;un de nos enregistreurs 21CFR, sinon nos enregistreurs standard suffiront.<\/p>\n<p>Un abonnement 21CFR Cloud offre toute la flexibilit\u00e9 de la surveillance \u00e0 distance et peut \u00eatre install\u00e9 dans le cadre d&rsquo;un syst\u00e8me conforme au 21CFR. Les fonctionnalit\u00e9s comprennent l&rsquo;utilisation bas\u00e9e sur les autorisations, la signature des niveaux d&rsquo;autorit\u00e9 et l&rsquo;audit complet du syst\u00e8me pour garantir que les donn\u00e9es contr\u00f4l\u00e9es et collect\u00e9es sont conformes \u00e0 la norme 21CFR Part 11. Cet appareil n\u00e9cessite un abonnement \u00e0 notre service EasyLog 21CFR Cloud.<\/p>\n<p>Ce produit est conforme \u00e0 la norme BS EN 12830:2018 (Enregistreurs de temp\u00e9rature pour le transport, le stockage et la distribution de marchandises sensibles \u00e0 la temp\u00e9rature).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Enregistreur de donn\u00e9es de vaccins cryog\u00e9niques WiFi conforme \u00e0 la norme 21CFR avec affichage<\/p>\n","protected":false},"featured_media":30283,"template":"","meta":{"_acf_changed":false,"content-type":"","_uag_custom_page_level_css":""},"product_brand":[],"product_cat":[1238],"product_tag":[1246,1228,2434,1232,1241,1242,1240,1227],"class_list":{"0":"post-30282","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-enregistreurs-de-donnees-de-temperature","7":"product_tag-21cfr-fr","8":"product_tag-affichage","9":"product_tag-easylog-fr","10":"product_tag-ido","11":"product_tag-sonde-externe","12":"product_tag-thermocouple-fr","13":"product_tag-ult-fr","14":"product_tag-wifi-fr","16":"first","17":"instock","18":"taxable","19":"shipping-taxable","20":"purchasable","21":"product-type-simple"},"bundled_by":[],"bundle_stock_status":"instock","bundle_stock_quantity":95,"bundle_virtual":false,"bundle_layout":"","bundle_add_to_cart_form_location":"","bundle_editable_in_cart":false,"bundle_sold_individually_context":"","bundle_item_grouping":"","bundle_min_size":"","bundle_max_size":"","bundle_price":[],"bundled_items":[],"bundle_sell_ids":[],"acf":[],"spectra_custom_meta":{"_download_limit":["-1"],"_download_expiry":["-1"],"_downloadable":["no"],"_sku":["EL-WiFi-21CFR-ULT"],"_stock_status":["instock"],"_sold_individually":["no"],"_tax_class":[""],"_tax_status":["taxable"],"_virtual":["no"],"_weight":["0"],"_width":["0"],"_height":["0"],"_length":["0"],"total_sales":["5"],"_product_datasheet":["field_650ad7d6ea3a0"],"connectivity":["WiFi"],"_connectivity":["field_64dce263bb57c"],"brand":["EasyLog"],"_brand":["field_64ddf62ed2593"],"_brand_image":["field_650c5e7c84cae"],"_specifications_table":["field_65044e1db92a8"],"_display_data_alarm":["field_667d647bcb066"],"_resources":["field_650849c6945ee"],"_accessories":["field_650849e6945f0"],"_faqs":["field_650859523d8d5"],"_calibration_suitable_ids_gb":["field_654b4c4acb54a"],"_calibration_suitable_ids_us":["field_654b4c56cb54b"],"_show_in_calibration_suitable":["field_654cfb691d345"],"_usd_price_4":["field_651570dcac479"],"_usd_price_9":["field_6515713eb4807"],"_usd_price_24":["field_65157141b4809"],"_usd_price_49":["field_65157140b4808"],"_usd_price_99":["field_6515715bb480a"],"_gbp_price_4":["field_6515716e83bfa"],"_gbp_price_9":["field_6515724783bfb"],"_gbp_price_24":["field_6515724b83bfc"],"_gbp_price_49":["field_6515725983bfd"],"_gbp_price_99":["field_6515725d83bfe"],"_usdhk_price_4":["field_6515726f83bff"],"_usdhk_price_9":["field_6515727c83c00"],"_usdhk_price_24":["field_6515728083c01"],"_usdhk_price_49":["field_6515728983c02"],"_usdhk_price_99":["field_6515728e83c03"],"stock_options":["In 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stockage<\/td>\n<td>illimit\u00e9e<\/td>\n<\/tr>\n<tr class=\"even-row\">\n<td class=\"left-td\">Dimensions (enregistreur)<\/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\">Dimensions (sonde)<\/td>\n<td>300 x \u00d81.5mm x 1m de c\u00e2ble (11.8 x \u00d80.06\" x 39.4\" de c\u00e2ble)<\/td>\n<\/tr>\n<tr class=\"even-row\">\n<td class=\"left-td\">Batterie<\/td>\n<td>Batterie rechargeable \/ 6 mois d'autonomie \/ Option alimentation secteur<\/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=\"Ic\u00f4ne de document\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/el-wifi-21cfr-ult_iss1_11-20-1.pdf\" target=\"_blank\" rel=\"noopener\"><span class=\"mldTitle\">Fiche technique EL-WiFi-21CFR-ULT<\/span><\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/software-icon.png\" alt=\"Ic\u00f4ne du logiciel\"><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=\"Ic\u00f4ne de document\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/el_21cfr_wifi_qsg_iss2_04-19.pdf\" target=\"_blank\" rel=\"noopener\">EL-21CFR-WiFi Guide de d\u00e9marrage rapide<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Ic\u00f4ne de document\"><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\">Exigences et param\u00e8tres du r\u00e9seau<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Ic\u00f4ne de document\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/conformity_certificate_wifi_range_with_coo-issu8.pdf\" target=\"_blank\" rel=\"noopener\">EL-WiFi-21CFR D\u00e9claration de conformit\u00e9<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Ic\u00f4ne de document\"><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 Attestation de conformit\u00e9<\/a><\/li>\n \t<li><img src=\"https:\/\/praxas.com\/wp-content\/uploads\/document-icon.png\" alt=\"Ic\u00f4ne de document\"><a href=\"https:\/\/praxas.com\/wp-content\/uploads\/21cfr-requirements-checklist_issue_3-04_2020-wifi.pdf\" target=\"_blank\" rel=\"noopener\">Liste de contr\u00f4le des exigences du 21CFR<\/a><\/li>\n<\/ul>\n<a class=\"button button-secondary\" href=\"https:\/\/praxas.com\/support\/\">Plus de soutien<\/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]Pouvez-vous nous expliquer ce qu'est le 21 CFR Part 11 ?[\/accordion_header]\n[accordion_section]Le Code of Federal Regulations 21 Part 11 de la FDA (Food & Drugs Administration) des \u00c9tats-Unis est une extension de la r\u00e9glementation existante qui d\u00e9finit les enregistrements et les signatures \u00e9lectroniques qui doivent \u00eatre consid\u00e9r\u00e9s comme exacts pour remplacer les enregistrements papier dans l'industrie pharmaceutique et m\u00e9dicale. Notre syst\u00e8me a \u00e9t\u00e9 con\u00e7u pour aider les entreprises \u00e0 se conformer \u00e0 ces r\u00e9glementations.[\/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]Le produit 21CFR Cloud conviendrait-il \u00e0 mon entreprise ?[\/accordion_header]\n[accordion_section]Ce produit a \u00e9t\u00e9 con\u00e7u pour les entreprises qui souhaitent utiliser des moyens \u00e9lectroniques pour remplacer en toute s\u00e9curit\u00e9 leurs dossiers papier afin de se conformer aux r\u00e9glementations 21 CFR Part 11 pour les industries pharmaceutiques et m\u00e9dicales. 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