{"id":28433,"date":"2023-07-27T03:12:00","date_gmt":"2023-07-27T01:12:00","guid":{"rendered":"https:\/\/staging.praxas.com\/product\/non%20class\u00e9\/el-wifi-21cfr-th\/"},"modified":"2025-10-09T10:02:02","modified_gmt":"2025-10-09T08:02:02","slug":"el-wifi-21cfr-th","status":"publish","type":"product","link":"https:\/\/praxas.com\/fr\/product\/data-loggers-fr\/temperature-et-humidite\/el-wifi-21cfr-th\/","title":{"rendered":"EL-WiFi-21CFR-TH"},"content":{"rendered":"<p>Cet enregistreur de donn\u00e9es de temp\u00e9rature, d&rsquo;humidit\u00e9 et de point de ros\u00e9e compatible Wi-Fi permet de surveiller \u00e0 distance un environnement sur une plage de mesures allant de -20 \u00e0 +60\u00b0C (-4 \u00e0 +140\u00b0F) et de 0 \u00e0 100% d&rsquo;humidit\u00e9 relative. Les donn\u00e9es sont t\u00e9l\u00e9charg\u00e9es p\u00e9riodiquement \u00e0 l&rsquo;aide d&rsquo;un r\u00e9seau WiFi standard, sans qu&rsquo;il soit n\u00e9cessaire de collecter physiquement l&rsquo;appareil et de le connecter \u00e0 un PC. Les donn\u00e9es sont transmises sans fil au syst\u00e8me <a href=\"https:\/\/21cfr.wifisensorcloud.com\/\" target=\"_blank\" rel=\"noopener\"><br \/>\n  <strong>EasyLog 21CFR Cloud<\/strong><br \/>\n<\/a>.<\/p>\n<p>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><\/p>\n<p>La 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. 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>L&rsquo;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 \u00e0 la norme 21CFR. Les fonctionnalit\u00e9s comprennent l&rsquo;utilisation bas\u00e9e sur les autorisations, l&rsquo;approbation du niveau d&rsquo;autorit\u00e9 et l&rsquo;audit complet du syst\u00e8me afin de 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 temp\u00e9rature et d&rsquo;humidit\u00e9 21CFR 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target=\"_blank\" rel=\"noopener\">EL-WiFi-21CFR-TH 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=\"PSU USB-UK,PSU USB-EU,EL-WiFi Wall Bracket\"]"],"faqs":["[accordion]\n[accordion_header]En quoi le 21CFR diff\u00e8re-t-il de l'EasyLog 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Les syst\u00e8mes conformes au 21CFR n\u00e9cessitent notre mat\u00e9riel d\u00e9sign\u00e9 21CFR et notre service en nuage 21CFR distinct.  [\/accordion_section]\n[\/accordion]\n\n[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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