[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fipP226GpUSE-PXjj032zhfD_tcTZZo79xzNSTs7K_Xg":3,"localizations-u7ca1f2v3guei9dnsq7wcqra-fr":810,"pages-en-fallback-u7ca1f2v3guei9dnsq7wcqra":823,"global-seo-setting":1256,"header-setting-fr":1303,"footer-fr":1365,"certificates":1484,"navigations-fr":1637,"localizations-pages-u7ca1f2v3guei9dnsq7wcqra-fr":1884},{"data":4,"meta":809},{"id":5,"title":6,"slug":7,"createdAt":8,"updatedAt":8,"publishedAt":9,"documentId":10,"locale":11,"showOnArticlesPage":12,"disablePrerender":12,"prerenderTranslation":13,"category":12,"tagCategory":12,"blogImage":12,"settings":12,"seo":14,"body":18},3914,"Pilier - Réglementations conformité température","reglementations-conformite-temperature","2026-08-25T12:53:18.510Z","2026-08-25T12:53:18.692Z","u7ca1f2v3guei9dnsq7wcqra","fr",null,false,{"id":15,"pageTitle":16,"shortDescription":17,"noIndex":13,"noAI":13,"noFollow":13,"Schema":12,"canonicalURL":12,"ogTitle":12,"ogDescription":12,"noSitemap":12,"schemaType":12,"image":12},5472,"Réglementations conformité température | Eupry","Pharma, biotech, logistique : décryptez les réglementations, normes et directives clés pour maîtriser la conformité température et simplifier vos audits.",[19,92,98,103,107,136,163,173,202,204,210,234,236,243,273,303,326,355,378,401,424,451,457,507,509,540,567,572,599,650,674,676,721,749,788],{"__component":20,"id":21,"title":22,"content":23,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":24,"preTitleColor":12,"ctaInfoText":12,"titleLevel":25,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":26,"media":34,"employee":61},"blocks.media-and-text-split-view",21869,"Réglementations clés de la conformité température","Passez-vous trop de temps à naviguer dans les réglementations, tout en craignant de ne pas satisfaire à _toutes_ les exigences et de ne pas respecter _toutes_ les normes applicables ?\n\nLorsque l'on travaille dans des secteurs hautement réglementés tels que la pharmacie, la biotechnologie et la logistique de santé, évoluer dans le paysage de la **conformité en matière de température** peut s'avérer complexe.\n\nHeureusement, nous sommes là pour vous accompagner.\n\nPassons en revue les domaines de conformité que vous _devriez_ maîtriser lorsque vous travaillez avec le contrôle de la température – du [monitoring](\u002Ftemperature-monitoring) à la [cartographie](\u002Ftemperature-mapping) et à l'[étalonnage](\u002Ftemperature-calibration) – afin de vous aider à les aborder en toute confiance.\n\n"," ","h1",[27],{"id":28,"title":29,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20270,"Automatisez la conformité en matière de température avec Eupry","\u002Four-solution","black","default","right",{"id":35,"name":36,"alternativeText":37,"caption":12,"width":38,"height":39,"formats":40,"hash":52,"ext":42,"mime":45,"size":53,"url":54,"previewUrl":12,"provider":55,"provider_metadata":56,"createdAt":57,"updatedAt":58,"documentId":59,"publishedAt":60,"focalPoint":12},588,"Awards - Square.jpg","Isometric illustration of a certification medal with a checkmark and ribbons on a light blue background",1198,903,{"thumbnail":41},{"ext":42,"url":43,"hash":44,"mime":45,"name":46,"path":12,"size":47,"width":48,"height":49,"provider_metadata":50},".jpg","https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707046422\u002Fthumbnail_Awards_Square_e5e9c029cb.jpg","thumbnail_Awards_Square_e5e9c029cb","image\u002Fjpeg","thumbnail_Awards - Square.jpg",2.37,207,156,{"public_id":44,"resource_type":51},"image","Awards_Square_e5e9c029cb",120.96,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707046423\u002FAwards_Square_e5e9c029cb.jpg","cloudinary",{"public_id":52,"resource_type":51},"2024-02-04T11:33:44.112Z","2026-03-26T10:55:18.169Z","koyhvdupoezbt2oo9etd36p8","2025-01-29T12:38:47.261Z",{"id":62,"name":63,"workTitle":64,"testimonial":12,"email":12,"linkedIn":65,"createdAt":66,"updatedAt":66,"publishedAt":67,"documentId":68,"locale":11,"url":69,"image":12,"thumbnail":12,"localizations":70},322,"Jakob Konradsen","DQO & co-fondateur","https:\u002F\u002Fwww.linkedin.com\u002Fin\u002Fjakob-konradsen-2ba0b694\u002F","2026-08-25T12:39:56.769Z","2026-08-25T12:39:56.853Z","ba20sn47jua4m2o1etu4g24b","\u002Fabout-us\u002Fjakob-konradsen\u002F",[71,78,85],{"id":72,"name":63,"workTitle":73,"testimonial":12,"email":12,"linkedIn":65,"createdAt":74,"updatedAt":75,"publishedAt":76,"documentId":68,"locale":77,"url":69},219,"CQO  & co-founder","2024-01-17T13:04:26.884Z","2026-06-17T10:11:37.023Z","2026-06-17T10:13:20.886Z","en",{"id":79,"name":63,"workTitle":80,"testimonial":12,"email":12,"linkedIn":65,"createdAt":81,"updatedAt":82,"publishedAt":83,"documentId":68,"locale":84,"url":69},319,"CQO & Mitgründer","2026-06-09T08:36:39.547Z","2026-08-17T11:41:20.257Z","2026-08-17T11:41:20.477Z","de",{"id":86,"name":63,"workTitle":87,"testimonial":12,"email":12,"linkedIn":65,"createdAt":88,"updatedAt":89,"publishedAt":90,"documentId":68,"locale":91,"url":69},320,"CQO e co-fondatore","2026-08-02T19:36:03.593Z","2026-08-17T11:41:21.320Z","2026-08-17T11:41:21.568Z","it",{"__component":20,"id":93,"title":94,"content":95,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":97,"media":12,"employee":12},21860,"Sur cette page, vous pouvez explorer :","- [Qu'est-ce que la conformité en matière de température ?](#whatIsTemperatureCompliance)\n- [Pourquoi les réglementations sont-elles nécessaires pour la conformité en matière de température ?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Réglementations, normes et lignes directrices – y a-t-il une différence ?](#regulationsStandardsGuidelines)\n- [Les principales réglementations et normes de la conformité en matière de température](#understandingKeyRegulationsAndStandards)\n- [3 étapes pour mettre en œuvre la conformité dans vos opérations](#3stepsToImplementingComplianceInYourOperations)\n- [Comment la technologie peut rendre la conformité en matière de température sans obstacle](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 problèmes fréquents de conformité en matière de température (et leurs solutions)](#8frequentTemperatureComplianceIssues)\n- [Questions fréquemment posées sur la conformité en matière de température](#faq)","h2",[],{"__component":99,"id":100,"title":101,"content":102,"blockId":12,"imageUrl":12,"hideOnMobile":12,"textColumns":12,"titleLevel":12,"media":12},"blocks.media-and-text-overflow-media",893,"Pas seulement la température","Bien que la température soit notre enfant préféré (et par conséquent le point central de cette page), de nombreuses réglementations et autres composantes de conformité sont tout aussi pertinentes pour la surveillance, la cartographie et l'étalonnage liés à l'**humidité**, au **CO2**, à la **pression différentielle** et à d'autres paramètres environnementaux.",{"__component":104,"id":105,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},"blocks.divider",28266,true,{"__component":20,"id":108,"title":109,"content":110,"blockId":111,"ulStyle":12,"video":12,"auto play":13,"imageLeftTextRight":13,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":112,"media":113,"employee":12},21861,"Qu'est-ce que la conformité en matière de température ?","Dans le monde de la pharmacie, de la distribution de médicaments et de la biotechnologie, il existe de nombreux domaines réglementaires différents, et même si vous travaillez dans le domaine de la qualité, il est possible que vous n'ayez pas souvent rencontré cette expression.\n\n**Néanmoins, ce concept recèle un potentiel considérable pour optimiser la façon dont nous traitons les problèmes de conformité liés à la température dans le cadre des BPx.**\n\n**En résumé :** La conformité en matière de température regroupe les tâches qualité destinées à garantir que les produits et échantillons sensibles à la température sont manipulés dans des plages de température spécifiques lors de la production, du stockage et du transport.\n\n**Elle repose sur trois disciplines principales :**\n- La surveillance de la température\n- La validation et la cartographie thermique\n- L'étalonnage des [enregistreurs de données](\u002Fsolutions\u002Fwireless-data-loggers) ou des capteurs\n","whatIsTemperatureCompliance",[],{"id":114,"name":115,"alternativeText":116,"caption":12,"width":117,"height":118,"formats":119,"hash":128,"ext":42,"mime":45,"size":129,"url":130,"previewUrl":12,"provider":55,"provider_metadata":131,"createdAt":132,"updatedAt":133,"documentId":134,"publishedAt":135,"focalPoint":12},1024,"Question.jpg","3D isometric white question mark icon on a mint green gradient background",1200,889,{"thumbnail":120},{"ext":42,"url":121,"hash":122,"mime":45,"name":123,"path":12,"size":124,"width":125,"height":49,"sizeInBytes":126,"provider_metadata":127},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1739784163\u002Fthumbnail_Question_8740a74dd2.jpg","thumbnail_Question_8740a74dd2","thumbnail_Question.jpg",3.41,211,3409,{"public_id":122,"resource_type":51},"Question_8740a74dd2",147.1,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1739784164\u002FQuestion_8740a74dd2.jpg",{"public_id":128,"resource_type":51},"2025-02-17T09:22:44.684Z","2026-03-26T10:59:57.656Z","gagqokbw0z2qrmyb8kkc8fks","2025-02-17T09:22:44.691Z",{"__component":20,"id":137,"title":138,"content":139,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":140,"media":145,"employee":12},21870,"Pourquoi la conformité en matière de température doit être gérée de manière unifiée","Dans la plupart des organisations, les domaines de la conformité en matière de température sont gérés de manière plus ou moins indépendante, par différents services opérant séparément avec leurs propres budgets, tâches, objectifs et priorités.\n\n**Or, cette approche est à la fois inefficace et risquée.**\n\nCes processus cloisonnés ne laissent pas seulement place à des efforts inutiles et redondants, à des goulots d'étranglement et à des temps morts — ils laissent également place à des lacunes dans la gestion.\n\nAutrement dit, lorsque la surveillance, l'étalonnage et la cartographie ne sont pas unifiés, vous risquez à la fois d'avoir des processus de travail inefficaces et de fragiliser votre position en matière de conformité.\n\nEn revanche, une approche unifiée vous permet de rationaliser les processus, d'intégrer les données, d'améliorer l'efficacité et de réduire les risques.",[141],{"id":142,"title":143,"href":144,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20271,"Comment unifier la conformité des températures","\u002Fregulations-temperature-compliance\u002Funify-temperature-compliance",{"id":146,"name":147,"alternativeText":148,"caption":12,"width":38,"height":39,"formats":149,"hash":156,"ext":42,"mime":45,"size":157,"url":158,"previewUrl":12,"provider":55,"provider_metadata":159,"createdAt":160,"updatedAt":161,"documentId":162,"publishedAt":60,"focalPoint":12},590,"Graphs - Square.jpg","Isometric illustration of a desktop monitor displaying a line graph and pie chart with data analytics icons",{"thumbnail":150},{"ext":42,"url":151,"hash":152,"mime":45,"name":153,"path":12,"size":154,"width":48,"height":49,"provider_metadata":155},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047079\u002Fthumbnail_Graphs_Square_f6ad60c79e.jpg","thumbnail_Graphs_Square_f6ad60c79e","thumbnail_Graphs - Square.jpg",3.94,{"public_id":152,"resource_type":51},"Graphs_Square_f6ad60c79e",222.52,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047079\u002FGraphs_Square_f6ad60c79e.jpg",{"public_id":156,"resource_type":51},"2024-02-04T11:44:40.175Z","2026-03-26T10:55:18.178Z","hyixp0bzf5k6aj3ejyiirrsu",{"__component":164,"id":165,"title":166,"lead":167,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":168,"card":172},"blocks.call-to-action",1006,"Psst...","La solution de conformité des températures d'Eupry garantit la conformité et le contrôle de **_tous_** vos efforts qualité liés à la température.",[169],{"id":170,"title":171,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20272,"Découvrez comment cela fonctionne",[],{"__component":174,"id":175,"title":176,"content":177,"video":12,"blockId":178,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":179,"media":180,"employee":12},"blocks.media-and-text",5993,"Pourquoi les réglementations sont-elles nécessaires pour la conformité des températures ?","C'est probablement une évidence, mais cela mérite d'être souligné : les réglementations en matière de conformité des températures ne sont pas là pour rendre notre travail plus chronophage, complexe et frustrant (mais soyons honnêtes, c'est souvent ce que l'on ressent). Leur seul objectif est de garantir que les produits restent efficaces et sûrs.\n\nDans la logistique de santé, l'industrie pharmaceutique, la biotechnologie et les secteurs similaires, un large éventail de produits et d'échantillons est très sensible aux moindres écarts de température. C'est pourquoi une [surveillance de la température](\u002Ftemperature-monitoring) et une [cartographie](\u002Ftemperature-mapping) méticuleuses sont nécessaires pour garantir la qualité. Des réglementations, des normes et des lignes directrices sont en place pour s'assurer que ces processus sont correctement exécutés, préservant ainsi l'intégrité et la sécurité de ces produits essentiels.","whyAreRegulationsNecessaryForTemperatureCompliance",[],{"id":181,"name":182,"alternativeText":183,"caption":12,"width":184,"height":185,"formats":186,"hash":195,"ext":42,"mime":45,"size":196,"url":197,"previewUrl":12,"provider":55,"provider_metadata":198,"createdAt":199,"updatedAt":200,"documentId":201,"publishedAt":60,"focalPoint":12},595,"pharmacist-work.jpg","Smiling pharmacist in white coat handing medication bag to customer at pharmacy counter",2000,941,{"thumbnail":187},{"ext":42,"url":188,"hash":189,"mime":45,"name":190,"path":12,"size":191,"width":192,"height":193,"provider_metadata":194},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707050198\u002Fthumbnail_pharmacist_work_8e8e408998.jpg","thumbnail_pharmacist_work_8e8e408998","thumbnail_pharmacist-work.jpg",6.93,245,115,{"public_id":189,"resource_type":51},"pharmacist_work_8e8e408998",282.21,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707050199\u002Fpharmacist_work_8e8e408998.jpg",{"public_id":195,"resource_type":51},"2024-02-04T12:36:39.701Z","2026-03-26T11:18:52.589Z","f5ufs4eph6m6xqidt79n6ytx",{"__component":104,"id":203,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},28267,{"__component":174,"id":205,"title":206,"content":207,"video":12,"blockId":208,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":209,"media":12,"employee":12},5994,"Réglementations, normes et lignes directrices – existe-t-il une différence ?","Dans le contexte de la qualité, les **normes**, les **lignes directrices** et les **réglementations** jouent chacune un rôle spécifique dans la définition des pratiques et des procédures – et la conformité dans les secteurs hautement réglementés implique souvent le respect d'une combinaison de ces trois éléments pour garantir la sécurité et l'efficacité.\n\nCette section explore les différentes définitions et cas d'usage de ces principes :","regulationsStandardsGuidelines",[],{"__component":20,"id":211,"title":12,"content":212,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":213,"media":214,"employee":12},21862,"## Les réglementations en matière de conformité des températures :\n- **Définition :** Les réglementations sont des exigences légales établies par des organismes gouvernementaux ou des agences de réglementation. Elles sont obligatoires et applicables en vertu de la loi.\n- **Caractéristiques :** Les réglementations sont souvent précises et fournissent des instructions ou des critères détaillés qui doivent être respectés. Elles ont force obligatoire, et le non-respect peut entraîner des sanctions juridiques, notamment des amendes ou des pénalités.\n- **Exemples :** Dans le contexte de la cartographie et de la surveillance des températures, les réglementations peuvent être émises par des entités telles que la [FDA](https:\u002F\u002Fwww.fda.gov\u002F) (U.S. Food and Drug Administration), l'[EMA](https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fhomepage) (Agence européenne des médicaments) ou d'autres autorités sanitaires nationales compétentes.\n\n## Les normes en matière de conformité des températures :\n- **Définition :** Les normes sont établies par consensus entre experts d'un domaine et sont souvent élaborées par des organismes de normalisation, tant internationaux que nationaux, tels que l'Organisation internationale de normalisation [ISO](https:\u002F\u002Fwww.iso.org\u002Fhome.html) ou l'American National Standards Institute [ANSI](https:\u002F\u002Fansi.org\u002F).\n- **Caractéristiques :** Les normes fournissent des lignes directrices pour les pratiques, garantissant la qualité, la sécurité et l'efficacité. Elles sont généralement volontaires, sauf si elles sont intégrées à une réglementation par un organisme de réglementation. Le respect des normes est souvent nécessaire pour l'acceptation sur le marché, la certification et, parfois, la conformité réglementaire.\n- **Exemples :** La norme ISO 9001 pour les systèmes de management de la qualité ou la norme [ISO 17025](\u002Fregulations-temperature-compliance\u002FIso-17025) relative à la compétence des laboratoires d'essais et d'étalonnage sont des normes qui, bien que volontaires, sont largement reconnues et appliquées dans les secteurs pharmaceutique, biotechnologique et de la logistique de santé.\n\n## Les lignes directrices en matière de conformité des températures :\n- **Définition :** Les lignes directrices sont des ensembles de recommandations ou de bonnes pratiques proposées par des organisations, souvent fondées sur des recherches et un consensus d'experts. Elles n'ont pas force exécutoire, mais visent à guider les professionnels du secteur dans des domaines spécifiques de leur activité.\n- **Caractéristiques :** Les lignes directrices sont généralement plus souples que les réglementations ou les normes, offrant des recommandations plutôt que des règles strictes. Elles sont conçues pour aider les organisations à obtenir de meilleurs résultats, mais n'ont pas valeur de loi.\n- **Exemples :** Les lignes directrices relatives aux [Bonnes Pratiques de Fabrication (BPF)](\u002Fregulations-temperature-compliance\u002Fgmp) fournissent des cadres permettant aux fabricants de s'assurer que les produits sont systématiquement fabriqués et contrôlés conformément aux normes de qualité, et les lignes directrices relatives aux [Bonnes Pratiques de Distribution (BPD)](\u002Fgdp) garantissent que la qualité et l'intégrité des produits sont maintenues lors du stockage et du transport. À noter que, bien que ces lignes directrices ne soient pas des lois en elles-mêmes, elles sont souvent fondées sur des réglementations.\n\n**En résumé :**\nLes réglementations ont force obligatoire et doivent être respectées, les normes sont des références volontaires qui peuvent devenir obligatoires lorsqu'elles sont adoptées par un organisme de réglementation, et les lignes directrices sont consultatives et fournissent des bonnes pratiques pour obtenir les meilleurs résultats.\n",[],{"id":215,"name":216,"alternativeText":217,"caption":12,"width":38,"height":218,"formats":219,"hash":227,"ext":42,"mime":45,"size":228,"url":229,"previewUrl":12,"provider":55,"provider_metadata":230,"createdAt":231,"updatedAt":232,"documentId":233,"publishedAt":60,"focalPoint":12},591,"Pattern 05 - Square.jpg","Light green abstract arc and curve pattern shapes arranged decoratively on white background",898,{"thumbnail":220},{"ext":42,"url":221,"hash":222,"mime":45,"name":223,"path":12,"size":224,"width":225,"height":49,"provider_metadata":226},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047361\u002Fthumbnail_Pattern_05_Square_b24f628700.jpg","thumbnail_Pattern_05_Square_b24f628700","thumbnail_Pattern 05 - Square.jpg",1.23,208,{"public_id":222,"resource_type":51},"Pattern_05_Square_b24f628700",60.34,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047360\u002FPattern_05_Square_b24f628700.jpg",{"public_id":227,"resource_type":51},"2024-02-04T11:49:21.636Z","2026-03-26T10:55:18.174Z","unqyxochoh2h4i890cemkxh1",{"__component":104,"id":235,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},28268,{"__component":237,"id":238,"title":239,"lead":240,"blockId":241,"ulStyle":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"imageUrl":12,"subTitle":12,"hideOnMobile":12,"ulColor":12,"hideLastUpdated":12,"buttons":242,"image":12,"employee":12},"blocks.hero",1847,"Comprendre les principales réglementations et normes en matière de conformité des températures","Intéressons-nous aux réglementations, normes et directives spécifiques applicables à vos procédures de [surveillance de la température](\u002Ftemperature-monitoring), de [cartographie](\u002Ftemperature-mapping) et d'[étalonnage](\u002Ftemperature-calibration\u002Four-calibration-solution). \n\n**Avertissement :** Ce qui suit est un résumé des normes couramment associées aux initiatives de conformité en matière de température. Veuillez noter que les normes spécifiques applicables à vos opérations varieront en fonction de votre secteur d'activité, de la nature de vos produits, de votre clientèle et d'autres considérations pertinentes.","understandingKeyRegulationsAndStandards",[],{"__component":20,"id":244,"title":245,"content":246,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":247,"media":252,"employee":12},21871,"FDA 21 CFR Part 11 – la pierre angulaire de la conformité numérique","[21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11) est un **règlement** qui définit les critères selon lesquels les signatures et les enregistrements électroniques – notamment les enregistrements numériques de température – peuvent être considérés comme fiables et dignes de confiance.\nIl fait partie du Code of Federal Regulations (CFR) établi par la Food and Drug Administration (FDA) des États-Unis. \n\n**À qui s'adresse-t-il ?**\n\nLe règlement 21 CFR Part 11 concerne les entreprises opérant dans des secteurs réglementés tels que l'industrie pharmaceutique et la biotechnologie, qui exercent leurs activités d'une quelconque manière aux États-Unis (partenaires, clients, distribution – tout est pris en compte), et qui utilisent des systèmes numériques de surveillance de la température – ou qui conservent simplement une version numérique des enregistrements de température à des fins de conformité. En d'autres termes, pratiquement toute entreprise travaillant avec des produits sensibles à la température.\nEn savoir plus sur la FDA 21 CFR Part 11. ",[248],{"id":249,"title":250,"href":251,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20273,"En savoir plus sur la FDA 21 CFR Part 11","\u002Fregulations-temperature-compliance\u002F21-cfr-part-11",{"id":253,"name":254,"alternativeText":255,"caption":12,"width":256,"height":257,"formats":258,"hash":266,"ext":42,"mime":45,"size":267,"url":268,"previewUrl":12,"provider":55,"provider_metadata":269,"createdAt":270,"updatedAt":271,"documentId":272,"publishedAt":60,"focalPoint":12},535,"FDA Part 11 compliance-regulation-logo.jpg","FDA logo with text reading 21 CFR Part 11 on light gray background",691,372,{"thumbnail":259},{"ext":42,"url":260,"hash":261,"mime":45,"name":262,"path":12,"size":263,"width":192,"height":264,"provider_metadata":265},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049708\u002Fthumbnail_FDA_Part_11_compliance_regulation_logo_d0683d50cf.jpg","thumbnail_FDA_Part_11_compliance_regulation_logo_d0683d50cf","thumbnail_FDA Part 11 compliance-regulation-logo.jpg",4.28,132,{"public_id":261,"resource_type":51},"FDA_Part_11_compliance_regulation_logo_d0683d50cf",61.36,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049708\u002FFDA_Part_11_compliance_regulation_logo_d0683d50cf.jpg",{"public_id":266,"resource_type":51},"2024-02-01T22:52:58.389Z","2026-03-26T09:38:09.349Z","r10k7w0yic2xph1hdrbkauio",{"__component":274,"id":275,"title":276,"lead":277,"hubspotFormId":278,"blockId":279,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":280},"blocks.download-form",4720,"Liste de contrôle de conformité FDA 21 CFR Part 11","Simplifiez la conformité à la 21 CFR Part 11 pour votre surveillance de la température grâce à notre checklist en 9 étapes.","cc99ef60-7394-4a8c-aa6c-b9db88b927f6","fdaDownload",{"id":281,"name":282,"alternativeText":283,"caption":12,"width":284,"height":285,"formats":286,"hash":296,"ext":288,"mime":291,"size":297,"url":298,"previewUrl":12,"provider":55,"provider_metadata":299,"createdAt":300,"updatedAt":301,"documentId":302,"publishedAt":60,"focalPoint":12},512,"CF#1 FDA Checklist Mockup.png","Stack of three booklets titled 9 steps to achieve compliant temperature monitoring records by Eupry",1889,2090,{"thumbnail":287},{"ext":288,"url":289,"hash":290,"mime":291,"name":292,"path":12,"size":293,"width":294,"height":49,"provider_metadata":295},".png","https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1717586968\u002Fthumbnail_CF_1_FDA_Checklist_Mockup_5095979d1e.png","thumbnail_CF_1_FDA_Checklist_Mockup_5095979d1e","image\u002Fpng","thumbnail_CF#1 FDA Checklist Mockup.png",36.91,141,{"public_id":290,"resource_type":51},"CF_1_FDA_Checklist_Mockup_5095979d1e",3096.36,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1717586968\u002FCF_1_FDA_Checklist_Mockup_5095979d1e.png",{"public_id":296,"resource_type":51},"2024-02-01T16:13:57.875Z","2026-03-26T09:45:01.359Z","ko5d4vmkokhdymap42vxpwjx",{"__component":20,"id":304,"title":305,"content":306,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":307,"media":308,"employee":12},21863,"FDA 21 CFR Part 211 – exigences pour la fabrication de produits pharmaceutiques","La 21 CFR Part **211** de la FDA (à ne pas confondre avec la Part 11, bien que nous comprenions que cela puisse arriver) est intitulée « Current Good Manufacturing Practice for Finished Pharmaceuticals ».\n\nCette **réglementation** couvre les Bonnes Pratiques de Fabrication (BPF) actuelles – les exigences minimales – relatives aux méthodes, installations et contrôles utilisés dans la fabrication, le traitement, le conditionnement ou la conservation d'un médicament, afin de garantir qu'il répond aux normes de qualité et est sûr à l'utilisation.\n\n**À qui s'adresse-t-elle ?**\n\nCette réglementation concerne les fabricants pharmaceutiques aux États-Unis. Elle garantit que les produits pharmaceutiques sont fabriqués dans des conditions environnementales appropriées, notamment en matière de contrôle de la température, afin d'assurer leur sécurité, leur pureté et leur efficacité.\n",[],{"id":309,"name":310,"alternativeText":311,"caption":12,"width":38,"height":218,"formats":312,"hash":319,"ext":42,"mime":45,"size":320,"url":321,"previewUrl":12,"provider":55,"provider_metadata":322,"createdAt":323,"updatedAt":324,"documentId":325,"publishedAt":60,"focalPoint":12},593,"Pattern 07 - Square.jpg","Orange quarter-circle arc shapes arranged in a diagonal cascading pattern on white background",{"thumbnail":313},{"ext":42,"url":314,"hash":315,"mime":45,"name":316,"path":12,"size":317,"width":225,"height":49,"provider_metadata":318},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047361\u002Fthumbnail_Pattern_07_Square_2508e0e723.jpg","thumbnail_Pattern_07_Square_2508e0e723","thumbnail_Pattern 07 - Square.jpg",2.46,{"public_id":315,"resource_type":51},"Pattern_07_Square_2508e0e723",83.5,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047361\u002FPattern_07_Square_2508e0e723.jpg",{"public_id":319,"resource_type":51},"2024-02-04T11:49:22.035Z","2026-03-26T09:39:45.255Z","q77959mbmdn8ig0dthzv2iqu",{"__component":20,"id":327,"title":328,"content":329,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":330,"media":336,"employee":12},21872,"ISO 17025 – la référence pour les laboratoires d'étalonnage et d'essai","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) est la norme internationale relative à la compétence des laboratoires d'[étalonnage](\u002Ftemperature-calibration\u002Four-calibration-solution). En d'autres termes, une accréditation ISO 17025 est un gage de qualité attestant qu'un laboratoire d'étalonnage répond aux plus hautes normes internationales en matière de précision.\n\nCette norme est élaborée par l'Organisation internationale de normalisation – [ISO](https:\u002F\u002Fwww.iso.org\u002Fabout-us.html) – une organisation indépendante et non gouvernementale regroupant 169 organismes nationaux de normalisation en tant que membres, chacun représentant l'ISO dans son pays respectif. L'organisation développe un large éventail de normes propriétaires, industrielles et commerciales afin de garantir la qualité, la sécurité et l'efficacité dans tous les secteurs d'activité.\n\n**À qui s'adresse-t-elle ?**\n\nCette norme concerne les laboratoires réalisant l'étalonnage d'instruments de mesure de la température et de l'humidité, afin de garantir l'exactitude et la fiabilité des mesures.\n\nPour les entreprises ne disposant pas d'un service d'étalonnage interne, une accréditation ISO 17025 peut s'avérer pertinente lors de la recherche de prestataires d'étalonnage ou d'[enregistreurs de données](\u002Fdata-logger) pré-étalonnés pour la surveillance ou la cartographie de la température.\n\nLa nécessité de recourir à un étalonnage accrédité ISO 17025 plutôt qu'à un étalonnage traçable, par exemple, dépend largement des exigences réglementaires du secteur, de l'importance critique de la précision des mesures dans les opérations, ainsi que des exigences des clients.\n\nPour les mesures non critiques, les secteurs à faible risque, le contrôle qualité interne et autres cas similaires, un étalonnage traçable peut être suffisant ; en revanche, pour les secteurs strictement réglementés avec des produits sensibles, un étalonnage accrédité ISO 17025 est souvent requis.\n",[331],{"id":332,"title":333,"href":334,"type":31,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20274,"En savoir plus sur la calibration accréditée ISO 17025","\u002Fregulations-temperature-compliance\u002Fiso-17025","none",{"id":337,"name":338,"alternativeText":339,"caption":12,"width":256,"height":257,"formats":340,"hash":348,"ext":42,"mime":45,"size":349,"url":350,"previewUrl":12,"provider":55,"provider_metadata":351,"createdAt":352,"updatedAt":353,"documentId":354,"publishedAt":60,"focalPoint":12},536,"ISO 17025 compliance-regulation-logo.jpg","ISO 17025 accreditation logo featuring a globe graphic with bold ISO lettering and standard number below",{"thumbnail":341},{"ext":42,"url":342,"hash":343,"mime":45,"name":344,"path":12,"size":345,"width":192,"height":264,"sizeInBytes":346,"provider_metadata":347},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1756306692\u002Fthumbnail_ISO_17025_compliance_regulation_logo_1418b0e10b.jpg","thumbnail_ISO_17025_compliance_regulation_logo_1418b0e10b","thumbnail_ISO 17025 compliance-regulation-logo.jpg",4.03,4026,{"public_id":343,"resource_type":51},"ISO_17025_compliance_regulation_logo_1418b0e10b",58.79,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1756306692\u002FISO_17025_compliance_regulation_logo_1418b0e10b.jpg",{"public_id":348,"resource_type":51},"2024-02-01T22:52:58.392Z","2026-03-26T11:16:21.879Z","dxxcwxpcrojlbr77q25fvayr",{"__component":20,"id":356,"title":357,"content":358,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":359,"media":360,"employee":12},21864,"ISO 9001 – le gage d'approbation du management de la qualité","ISO 9001 est une norme mondialement reconnue pour les systèmes de management de la qualité (SMQ). \n\nElle définit les critères d'un SMQ afin de garantir la qualité constante des produits et services, en répondant à la fois aux exigences des clients et aux exigences réglementaires.\n\nLa norme repose sur un ensemble de principes de management de la qualité, notamment l'orientation client, l'implication de la direction de l'entreprise, une approche par les processus et l'amélioration continue.\n\nEn matière de conformité des températures, le rôle de l'ISO 9001 est de garantir que les processus de contrôle des températures sont gérés de manière fiable et continuellement améliorés, dans le respect des normes du secteur. Qu'il s'agisse de garantir l'efficacité des médicaments ou la fiabilité des dispositifs médicaux, l'ISO 9001 pose les bases du maintien de standards de qualité élevés dans les opérations sensibles à la température.\n\n**À qui s'adresse-t-elle ?**\n\nLa norme ISO 9001 est délibérément conçue pour être suffisamment générale afin que presque toutes les organisations puissent s'y reconnaître et l'utiliser pour améliorer leur qualité. Elle apporte une valeur ajoutée particulièrement importante aux organisations évoluant dans des secteurs où la fourniture d'une qualité constante est essentielle. Elle s'applique notamment aux entreprises pharmaceutiques, aux sociétés de biotechnologie, aux fabricants de dispositifs médicaux et à toute entreprise impliquée dans le cycle de vie des produits liés à la santé.",[],{"id":361,"name":362,"alternativeText":363,"caption":12,"width":256,"height":257,"formats":364,"hash":371,"ext":42,"mime":45,"size":372,"url":373,"previewUrl":12,"provider":55,"provider_metadata":374,"createdAt":375,"updatedAt":376,"documentId":377,"publishedAt":60,"focalPoint":12},539,"ISO compliance-regulation-logo.jpg","ISO 9001 certification logo with globe graphic and International Organization for Standardization text",{"thumbnail":365},{"ext":42,"url":366,"hash":367,"mime":45,"name":368,"path":12,"size":369,"width":192,"height":264,"provider_metadata":370},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049641\u002Fthumbnail_ISO_compliance_regulation_logo_4df7ce7843.jpg","thumbnail_ISO_compliance_regulation_logo_4df7ce7843","thumbnail_ISO compliance-regulation-logo.jpg",4.04,{"public_id":367,"resource_type":51},"ISO_compliance_regulation_logo_4df7ce7843",48.68,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049641\u002FISO_compliance_regulation_logo_4df7ce7843.jpg",{"public_id":371,"resource_type":51},"2024-02-01T22:52:58.430Z","2026-03-26T09:40:12.711Z","kx3jvk98037mj7bfxs5u89uo",{"__component":20,"id":379,"title":380,"content":381,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":382,"media":383,"employee":12},21865,"GxP – le cadre des bonnes pratiques","Le GxP englobe un ensemble de lignes directrices de conformité telles que les [Bonnes Pratiques de Fabrication (BPF)](\u002Fregulations-temperature-compliance\u002Fgmp\u002F), les Bonnes Pratiques de Laboratoire (BPL), les Bonnes Pratiques Cliniques (BPC) et les [Bonnes Pratiques de Distribution (BPD)](\u002Fgdp).\n\nCes lignes directrices sont essentielles pour garantir que les produits sont sûrs, répondent à leur usage prévu et respectent les processus de qualité tout au long de leur cycle de vie. Dans le contexte pharmaceutique, le GxP constitue le fondement de la réglementation du développement et de la fabrication des médicaments.\n\n**Voir aussi** : [L'IA dans le GxP : ce qui fonctionne et ce qui est risqué](\u002Fai)\n\n**À qui s'adresse-t-il ?**\n\nDifférentes déclinaisons des lignes directrices [GxP](\u002Fregulations-temperature-compliance\u002Fgxp\u002F) concernent un large éventail d'organisations dans des secteurs où la qualité et la conformité des températures sont essentielles – entreprises pharmaceutiques, organisations de biotechnologie, recherche clinique, prestataires de soins de santé, laboratoires, ainsi que la logistique et la distribution, en particulier lors de la gestion de produits pharmaceutiques.\n\n**Voir aussi** : [Comment satisfaire aux exigences de température BPF](\u002Fregulations-temperature-compliance\u002Fgmp\u002F)",[],{"id":384,"name":385,"alternativeText":386,"caption":12,"width":38,"height":39,"formats":387,"hash":394,"ext":42,"mime":45,"size":395,"url":396,"previewUrl":12,"provider":55,"provider_metadata":397,"createdAt":398,"updatedAt":399,"documentId":400,"publishedAt":60,"focalPoint":12},594,"GxP - Square.jpg","3D isometric GxP text logo in dark navy and light blue on a pale blue background",{"thumbnail":388},{"ext":42,"url":389,"hash":390,"mime":45,"name":391,"path":12,"size":392,"width":48,"height":49,"provider_metadata":393},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707048441\u002Fthumbnail_Gx_P_Square_18cb1e7c20.jpg","thumbnail_Gx_P_Square_18cb1e7c20","thumbnail_GxP - Square.jpg",2.44,{"public_id":390,"resource_type":51},"Gx_P_Square_18cb1e7c20",99.56,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707048441\u002FGx_P_Square_18cb1e7c20.jpg",{"public_id":394,"resource_type":51},"2024-02-04T12:07:22.131Z","2026-03-26T10:55:18.177Z","kic58bg4pv04a4ptmfzune6d",{"__component":20,"id":402,"title":403,"content":404,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":405,"media":406,"employee":12},21866,"USP \u003C1079> – lignes directrices pour le stockage et la distribution à température contrôlée","USP \u003C1079> est une ligne directrice élaborée par la Pharmacopée des États-Unis (USP) – une organisation scientifique à but non lucratif qui établit des normes publiques reconnues au niveau fédéral pour les médicaments, les compléments alimentaires et les ingrédients alimentaires.\n\nElle définit les meilleures pratiques pour le stockage et la distribution de produits pharmaceutiques dans des conditions de température contrôlée, en préservant l'intégrité des produits tout au long de la chaîne d'approvisionnement et en mettant l'accent sur la surveillance, le contrôle et la documentation des températures.\n\n**À qui s'adresse-t-elle ?**\n\nUSP \u003C1079> s'applique aux organisations intervenant dans la chaîne d'approvisionnement pharmaceutique, notamment les fabricants, les distributeurs et les installations de stockage. Elle est particulièrement pertinente pour les entités manipulant des produits pharmaceutiques thermosensibles, pour lesquels le maintien de conditions environnementales spécifiques est essentiel à l'efficacité et à la sécurité des produits.\n\nBien que USP \u003C1079> soit spécifiquement adaptée à l'industrie pharmaceutique, les principes énoncés dans cette ligne directrice peuvent être instructifs pour d'autres secteurs manipulant des produits sensibles.\n",[],{"id":407,"name":408,"alternativeText":409,"caption":12,"width":256,"height":257,"formats":410,"hash":417,"ext":42,"mime":45,"size":418,"url":419,"previewUrl":12,"provider":55,"provider_metadata":420,"createdAt":421,"updatedAt":422,"documentId":423,"publishedAt":60,"focalPoint":12},534,"USP compliance-regulation-logo.jpg","USP (United States Pharmacopeia) logo featuring black triangle mountain shape with white USP letters and trademark symbol",{"thumbnail":411},{"ext":42,"url":412,"hash":413,"mime":45,"name":414,"path":12,"size":415,"width":192,"height":264,"provider_metadata":416},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049629\u002Fthumbnail_USP_compliance_regulation_logo_56443166f4.jpg","thumbnail_USP_compliance_regulation_logo_56443166f4","thumbnail_USP compliance-regulation-logo.jpg",2.68,{"public_id":413,"resource_type":51},"USP_compliance_regulation_logo_56443166f4",26.47,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049628\u002FUSP_compliance_regulation_logo_56443166f4.jpg",{"public_id":417,"resource_type":51},"2024-02-01T22:52:58.337Z","2026-03-26T09:37:38.312Z","lo6jywzmqzd91f8ivuitwfia",{"__component":20,"id":425,"title":426,"content":427,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":428,"media":433,"employee":12},21873,"OMS – un panorama mondial des lignes directrices relatives à la cartographie","L'Organisation mondiale de la Santé (OMS), gardienne internationale de la santé publique, fournit des lignes directrices pour la protection des produits de santé à l'échelle mondiale. Ces lignes directrices sont conçues pour gérer le processus complexe de stockage et de transport des produits de santé dans des environnements climatiques variés.\n\nLe choix des lignes directrices OMS pertinentes pour votre organisation dépend de vos besoins spécifiques et de la nature des produits que vous manipulez – mais le [Supplément 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002FAnnex-9-f-trs-961) : « Qualification des zones de stockage à température contrôlée », le [Supplément 8](https:\u002F\u002Fcdn.who.int\u002Fmedia\u002Fdocs\u002Fdefault-source\u002Fmedicines\u002Fnorms-and-standards\u002Fguidelines\u002Fdistribution\u002Ftrs961-annex9-supp8.pdf?sfvrsn=fb423ff8_2&download=true) : « Cartographie thermique des zones de stockage », et l'[Annexe 8](https:\u002F\u002Fwww.who.int\u002Fdocs\u002Fdefault-source\u002Fmedicines\u002Fnorms-and-standards\u002Fguidelines\u002Fproduction\u002Ftrs1010-annex8-who-gmp-heating-ventilation-airconditioning.pdf?sfvrsn=c77698e2_0) : « Lignes directrices sur les systèmes de chauffage, de ventilation et de climatisation pour les produits pharmaceutiques non stériles » offrent des conseils ciblés pour différents scénarios de cartographie thermique.\n\n**À qui s'adressent-elles ?**\n\nLes lignes directrices de l'OMS figurant dans le Supplément 7, le Supplément 8 et l'Annexe 8 concernent tout secteur gérant le stockage, la manipulation et la distribution de produits thermosensibles, garantissant l'intégrité et la sécurité des produits – des entreprises pharmaceutiques aux organisations de logistique de santé.\n\nCes lignes directrices sont, comme leur nom l'indique, des lignes directrices, et non des normes ou des réglementations formelles. Cependant, bien qu'elles ne soient pas légalement contraignantes, elles représentent les meilleures pratiques et peuvent servir de principe directeur pour garantir la fiabilité de vos [études de cartographie thermique](\u002Ftemperature-mapping). Par ailleurs, l'OMS étant une autorité reconnue en matière de santé à l'échelle mondiale et ses lignes directrices étant considérées comme bien fondées, celles-ci sont souvent utilisées comme base pour les réglementations nationales.\n\n[Consultez notre guide complet des lignes directrices de l'OMS en matière de cartographie thermique](\u002Ftemperature-mapping\u002Fwho-mapping-guidelines\u002F)",[429],{"id":430,"title":431,"href":432,"type":31,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20275,"Consulter notre guide de cartographie OMS","\u002Ftemperature-mapping\u002Fwho-mapping-guidelines",{"id":434,"name":435,"alternativeText":436,"caption":12,"width":256,"height":257,"formats":437,"hash":444,"ext":42,"mime":45,"size":445,"url":446,"previewUrl":12,"provider":55,"provider_metadata":447,"createdAt":448,"updatedAt":449,"documentId":450,"publishedAt":60,"focalPoint":12},537,"WHO - compliance-regulation-logo.jpg","WHO logo featuring a Rod of Asclepius over a world map, surrounded by laurel branches",{"thumbnail":438},{"ext":42,"url":439,"hash":440,"mime":45,"name":441,"path":12,"size":442,"width":192,"height":264,"provider_metadata":443},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049604\u002Fthumbnail_WHO_compliance_regulation_logo_6ab3ababb6.jpg","thumbnail_WHO_compliance_regulation_logo_6ab3ababb6","thumbnail_WHO - compliance-regulation-logo.jpg",4.78,{"public_id":440,"resource_type":51},"WHO_compliance_regulation_logo_6ab3ababb6",91.35,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049604\u002FWHO_compliance_regulation_logo_6ab3ababb6.jpg",{"public_id":444,"resource_type":51},"2024-02-01T22:52:58.395Z","2026-03-26T09:40:49.421Z","sz9ajus2c16a6yidbpcsovbs",{"__component":452,"id":453,"text":454,"columns":455,"title":12,"blockId":12,"hideOnMobile":12,"ulStyle":12,"ulColor":12,"withBackground":12,"buttons":456},"blocks.text",5046,"[![10-step Checklist_ Following WHO's temperature mapping guidelines.png](https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1721822665\u002F10_step_Checklist_Following_WHO_s_temperature_mapping_guidelines_101e4db8a5.png)](\u002Ftemperature-mapping\u002Fwho-mapping-guidelines\u002F#download)","one",[],{"__component":458,"id":459,"title":460,"content":461,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":106,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":462},"blocks.faq",3419,"Autres normes et directives pertinentes","\n\n\n\n\n",[463,467,471,475,479,483,487,491,495,499,503],{"id":464,"question":465,"answer":466},24087,"Directives de l'OMS pour les bonnes pratiques de stockage","Le « [TRS 1025 - Annexe 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002Ftrs-1025-annex-7) » est une directive mondiale soulignant les conditions de stockage appropriées, y compris les exigences en matière de température, pour les produits médicaux.",{"id":468,"question":469,"answer":470},24088,"ICH Q10 (Système qualité pharmaceutique)","Englobe l'ensemble du cycle de vie pharmaceutique, en intégrant les Bonnes Pratiques de Fabrication (BPF) avec les systèmes qualité et la gestion des risques.",{"id":472,"question":473,"answer":474},24089,"Annexe 11 UE (Europe)","Similaire à [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11), l'Annexe 11 UE se concentre sur les enregistrements numériques. Elle couvre la manière dont les enregistrements dans le secteur pharmaceutique, y compris ceux liés au contrôle de la température, doivent être gérés afin de garantir leur intégrité, leur fiabilité et leur conformité aux réglementations de l'UE.",{"id":476,"question":477,"answer":478},24090,"Annexe 15 des BPF UE","Ce texte traite de la qualification et de la validation des procédés et des systèmes utilisés dans la fabrication pharmaceutique, notamment en s'assurant que les [systèmes de surveillance de la température](\u002Ftemperature-monitoring\u002Fsystems) sont qualifiés et validés. L'accent est mis sur les aspects physiques et les performances des équipements et des procédés, afin de garantir qu'ils sont adaptés à l'usage prévu et qu'ils répondent aux spécifications définies.",{"id":480,"question":481,"answer":482},24091,"EudraLex Volume 4 (UE)","Ce document fournit des directives relatives à la fabrication, à l'importation et à la distribution des médicaments dans l'UE.",{"id":484,"question":485,"answer":486},24092,"ASTM E2500","Une norme développée par [ASTM International](https:\u002F\u002Fwww.astm.org\u002F), fournissant un guide pour la spécification, la conception et la vérification des systèmes et équipements de fabrication pharmaceutique et biopharmaceutique, couvrant, entre autres aspects, le contrôle de la température.",{"id":488,"question":489,"answer":490},24093,"EN 12830","Exigences relatives aux enregistreurs de température utilisés dans le transport, le stockage et la distribution de produits alimentaires sensibles à la température.",{"id":492,"question":493,"answer":494},24094,"ASTM E2870","Évalue l'efficacité des formulations antimicrobiennes pour le lavage des mains, pour lesquelles le contrôle de la température pendant les tests est essentiel.",{"id":496,"question":497,"answer":498},24095,"Normes ASHRAE","Directives relatives aux systèmes CVC, essentielles au maintien de températures contrôlées dans les installations.",{"id":500,"question":501,"answer":502},24096,"AAMI ST79","Guide complet sur la stérilisation à la vapeur dans les établissements de santé, où le contrôle de la température est essentiel à la stérilité.",{"id":504,"question":505,"answer":506},24097,"CLSI M22-A3","Contrôle qualité des milieux de culture microbiologique préparés commercialement, avec un accent particulier sur le contrôle de la température lors de la préparation et du stockage.",{"__component":104,"id":508,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},28269,{"__component":510,"id":511,"title":512,"content":513,"blockId":12,"imageUrl":12,"hideOnMobile":12,"buttons":514,"backgroundImage":520},"blocks.media-and-text-overlay",532,"C'était beaucoup… ","**Heureusement, toutes les réglementations ne s'appliquent pas à vos activités.**\n\n**Alors, lesquelles vous concernent ? Nos spécialistes en conformité sont prêts à vous aider (sans engagement).**",[515],{"id":516,"title":517,"href":518,"type":519,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20276,"Réserver une consultation gratuite de 15 minutes","\u002Fbook-demo","white",{"id":521,"name":522,"alternativeText":523,"caption":12,"width":184,"height":524,"formats":525,"hash":533,"ext":42,"mime":45,"size":534,"url":535,"previewUrl":12,"provider":55,"provider_metadata":536,"createdAt":537,"updatedAt":538,"documentId":539,"publishedAt":60,"focalPoint":12},549,"adamSupport.jpg","Young professional man in light blue shirt smiling in modern office, Eupry team member Adam from customer support",1113,{"thumbnail":526},{"ext":42,"url":527,"hash":528,"mime":45,"name":529,"path":12,"size":530,"width":192,"height":531,"provider_metadata":532},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1706905955\u002Fthumbnail_adam_Support_cba96f8819.jpg","thumbnail_adam_Support_cba96f8819","thumbnail_adamSupport.jpg",5.71,136,{"public_id":528,"resource_type":51},"adam_Support_cba96f8819",227.72,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1706905955\u002Fadam_Support_cba96f8819.jpg",{"public_id":533,"resource_type":51},"2024-02-02T12:16:21.479Z","2026-03-26T10:51:05.176Z","ujd7jkw0503im54hffccs0r6",{"__component":541,"id":542,"title":543,"lead":544,"iconStyle":545,"withBackground":106,"blockId":546,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":547},"blocks.icon-grid",4724,"3 étapes pour mettre en œuvre la conformité dans vos opérations","Nous avons passé en revue une multitude de réglementations et d'exigences de conformité relatives au contrôle de la température des produits pharmaceutiques et autres produits et échantillons sensibles à la température.\nComment satisfaire les auditeurs et intégrer les règles et bonnes pratiques pertinentes dans vos opérations ?\nIl n'existe pas de solution universelle, mais trois domaines principaux sont à prendre en compte : \n","Style 1","3stepsToImplementingComplianceInYourOperations",[548,555,562],{"id":549,"title":550,"lead":551,"icon":552,"linkTitle":553,"linkHref":554,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23520,"Utiliser un système de surveillance de la température (conforme)","La mise en œuvre d'un système de surveillance de la température fiable et son utilisation conforme aux réglementations sont essentielles pour la conformité en matière de température. Les systèmes doivent fournir une surveillance en temps réel, un enregistrement des données et des alertes instantanées afin de préserver l'intégrité des produits sensibles.","Monitoring","Critères de sélection","\u002Ftemperature-monitoring\u002Fsystems",{"id":556,"title":557,"lead":558,"icon":559,"linkTitle":560,"linkHref":561,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23521,"Réaliser des cartographies thermiques régulières","La cartographie thermique est utilisée pour valider que les environnements de stockage respectent de manière constante les spécifications de température requises – et sa réalisation fait partie des réglementations applicables à la plupart des secteurs travaillant avec des produits thermosensibles. Elle implique une analyse détaillée de la distribution de la température au sein d'une zone de stockage, garantissant l'uniformité et identifiant les éventuelles zones problématiques.","Mapping","Comment réaliser une cartographie conforme","\u002Ftemperature-mapping",{"id":563,"title":564,"lead":565,"icon":566,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23522,"Utilisation d'équipements étalonnés","Le fondement d'une mesure fiable. L'étalonnage régulier des équipements de surveillance de la température est nécessaire pour la conformité dans la plupart des secteurs. Il garantit la précision des enregistreurs de données et des capteurs, ainsi que la fiabilité des données.","Calibration",{"__component":174,"id":568,"title":569,"content":570,"video":12,"blockId":12,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":571,"media":12,"employee":12},5995,"Naturellement,","cet aperçu ne couvre pas tous les aspects de la conformité en matière de température pour votre organisation. Cependant, ces trois domaines – la surveillance, la cartographie et l'étalonnage – constituent les piliers de la conformité en matière de température, et la mise en place de systèmes et de processus fiables pour chacun d'eux peut servir de cadre pour développer une configuration conforme.\n\n**Découvrez ensuite comment la technologie peut contribuer à simplifier considérablement ce processus.**",[],{"__component":274,"id":573,"title":574,"lead":575,"hubspotFormId":576,"blockId":577,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":578},4721,"Conformité automatisée de la température en un seul endroit","La conformité en matière de température ne devrait pas être une contrainte.\n\nGardez le contrôle total de votre conformité en matière de température à tout moment. Regroupez la [surveillance](\u002Ftemperature-monitoring\u002Four-monitoring-solution\u002F), la [cartographie](\u002Ftemperature-mapping\u002Four-mapping-solution\u002F) et l'[étalonnage](\u002Ftemperature-calibration\u002Four-calibration-solution\u002F) dans une solution unique conforme aux BPx.","9d85dec8-9dde-4f4a-8da2-3db5be5aea57","catalogDownload",{"id":579,"name":580,"alternativeText":581,"caption":12,"width":582,"height":583,"formats":584,"hash":592,"ext":288,"mime":291,"size":593,"url":594,"previewUrl":12,"provider":55,"provider_metadata":595,"createdAt":596,"updatedAt":597,"documentId":598,"publishedAt":60,"focalPoint":12},775,"CatalogMockup - multiple pages 01.png","Three overlapping pages from Eupry's product catalog showing compliance features, software interface, and mapping solution se",2243,2156,{"thumbnail":585},{"ext":288,"url":586,"hash":587,"mime":291,"name":588,"path":12,"size":589,"width":590,"height":49,"provider_metadata":591},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1716796563\u002Fthumbnail_Catalog_Mockup_multiple_pages_01_77cf322d34.png","thumbnail_Catalog_Mockup_multiple_pages_01_77cf322d34","thumbnail_CatalogMockup - multiple pages 01.png",27.66,162,{"public_id":587,"resource_type":51},"Catalog_Mockup_multiple_pages_01_77cf322d34",2868.62,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1716796559\u002FCatalog_Mockup_multiple_pages_01_77cf322d34.png",{"public_id":592,"resource_type":51},"2024-05-27T07:56:04.227Z","2026-03-26T09:38:44.105Z","o2nt9afsaareuldkr1hubbey",{"__component":541,"id":600,"title":601,"lead":602,"iconStyle":603,"withBackground":13,"blockId":604,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":605},4725,"Comment la technologie peut rendre la conformité en matière de température sans obstacle","Naviguer dans la conformité en matière de température implique de se repérer dans un ensemble complet de réglementations, de normes et de lignes directrices, ce qui peut s'avérer complexe et fastidieux.\n\nHeureusement, ces dernières années, des avancées techniques et des [solutions de surveillance numérique](\u002Ftemperature-monitoring\u002Fsystems) ont vu le jour, conçues pour que la conformité ne soit plus un obstacle pour les utilisateurs.\n","Style 2","howTechnologyCanMakeTemperatureComplianceANonIssue",[606,611,616,621,626,631,635,640,645],{"id":607,"title":608,"lead":609,"icon":610,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23523,"Suivi de la température en temps réel et automatisé","pour permettre une action immédiate en cas d'écart.","Therometer",{"id":612,"title":613,"lead":614,"icon":615,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23524,"Alarmes avancées","fournissant des alertes personnalisables, éliminant les zones grises et adaptant les notifications en fonction des besoins spécifiques de conformité.","BellNotification",{"id":617,"title":618,"lead":619,"icon":620,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23525,"Enregistrement automatisé des déviations","rendant l'enregistrement, l'analyse et le reporting des excursions plus efficaces.","GraphUp",{"id":622,"title":623,"lead":624,"icon":625,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23526,"Rapports prêts pour l'audit","générés en quelques clics pour simplifier les audits.","Document1",{"id":627,"title":628,"lead":629,"icon":630,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23527,"Une base de données unique","avec \u003Cu>toutes\u003C\u002Fu> les données de température accessibles en un seul endroit, y compris les alarmes, les certificats d'étalonnage et les protocoles de cartographie.","DeviceDesktop",{"id":632,"title":633,"lead":634,"icon":566,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23528,"Gestion de l'étalonnage","assurant non seulement le suivi des certificats d'étalonnage, mais également des plannings.",{"id":636,"title":637,"lead":638,"icon":639,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23529,"Fonctionnalités spécifiques à la conformité","comme les modules conçus pour la [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11).","Award",{"id":641,"title":642,"lead":643,"icon":644,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23530,"Niveaux de flexibilité variables","dans les seuils de température pour répondre à vos exigences réglementaires.","BarChartUp",{"id":646,"title":647,"lead":648,"icon":649,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},23531,"Et bien plus encore","Certaines solutions incluent également l'accès à un support spécialisé pouvant fournir des conseils et une assistance sur vos problèmes de conformité.\n\nEn d'autres termes, les solutions modernes peuvent être utilisées pour automatiser et rationaliser – et l'automatisation signifie l'élimination des erreurs manuelles et des incohérences dans la tenue des registres, rendant la conformité plus fiable.\n\n","CheckmarkRectangle",{"__component":274,"id":651,"title":652,"lead":653,"hubspotFormId":654,"blockId":655,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":656},4722,"Liste de contrôle : 8 problèmes fréquents de conformité des températures"," **(et leurs solutions)**\nLa conformité des températures est complexe et, par conséquent, des erreurs se produisent. Plongez dans les problèmes les plus courants de conformité des températures - et comment vous pouvez les éviter.","9a064f4e-708a-4869-816a-534e2e425941","8frequentTemperatureComplianceIssues",{"id":657,"name":658,"alternativeText":659,"caption":12,"width":284,"height":285,"formats":660,"hash":667,"ext":288,"mime":291,"size":668,"url":669,"previewUrl":12,"provider":55,"provider_metadata":670,"createdAt":671,"updatedAt":672,"documentId":673,"publishedAt":60,"focalPoint":12},807,"8 frequent temperature compliance issues Mockup.png","Mockup of Eupry's white paper booklet titled \"8 Frequent Temperature Compliance Issues (and their solutions)",{"thumbnail":661},{"ext":288,"url":662,"hash":663,"mime":291,"name":664,"path":12,"size":665,"width":294,"height":49,"provider_metadata":666},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1718277700\u002Fthumbnail_8_frequent_temperature_compliance_issues_Mockup_5970a7fc6b.png","thumbnail_8_frequent_temperature_compliance_issues_Mockup_5970a7fc6b","thumbnail_8 frequent temperature compliance issues Mockup.png",34.99,{"public_id":663,"resource_type":51},"8_frequent_temperature_compliance_issues_Mockup_5970a7fc6b",3183.26,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1718277700\u002F8_frequent_temperature_compliance_issues_Mockup_5970a7fc6b.png",{"public_id":667,"resource_type":51},"2024-06-13T11:21:41.650Z","2026-03-26T09:43:30.677Z","yw8fx9bk1qk9k76e29qjkhen",{"__component":104,"id":675,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},28270,{"__component":20,"id":677,"title":678,"content":679,"blockId":680,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":681,"media":682,"employee":12},21867,"Questions fréquemment posées sur la conformité des températures","Nous avons déjà abordé certaines des questions les plus courantes concernant les réglementations et la conformité pour la surveillance des températures, la cartographie thermique et l'étalonnage. \n\n- [Qu'est-ce que la conformité des températures ?](#whatIsTemperatureCompliance)\n- [Pourquoi les réglementations sont-elles nécessaires pour la conformité des températures ?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Réglementations, normes et directives – y a-t-il une différence ?](#regulationsStandardsGuidelines)\n- [Comprendre les principales réglementations et normes de conformité des températures](#understandingKeyRegulationsAndStandards)\n- [3 étapes pour mettre en œuvre la conformité dans vos opérations](#3stepsToImplementingComplianceInYourOperations)\n- [Comment la technologie peut rendre la conformité des températures sans problème](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 problèmes fréquents de conformité des températures (et leurs solutions)](#7frequentTemperatureComplianceIssues)\n- [Questions fréquemment posées sur la conformité des températures](#faq)\n","faq",[],{"id":683,"name":684,"alternativeText":685,"caption":12,"width":38,"height":686,"formats":687,"hash":714,"ext":42,"mime":45,"size":715,"url":716,"previewUrl":12,"provider":717,"provider_metadata":12,"createdAt":718,"updatedAt":719,"documentId":720,"publishedAt":60,"focalPoint":12},508,"Magnifying - Square.jpg","Isometric illustration of a dark navy magnifying glass on a light mint green background",886,{"large":688,"small":695,"medium":702,"thumbnail":709},{"ext":42,"url":689,"hash":690,"mime":45,"name":691,"path":12,"size":692,"width":693,"height":694},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Flarge_Magnifying_Square_3f7ec0439b.jpg","large_Magnifying_Square_3f7ec0439b","large_Magnifying - Square.jpg",19.31,1000,740,{"ext":42,"url":696,"hash":697,"mime":45,"name":698,"path":12,"size":699,"width":700,"height":701},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Fsmall_Magnifying_Square_3f7ec0439b.jpg","small_Magnifying_Square_3f7ec0439b","small_Magnifying - Square.jpg",8.09,500,370,{"ext":42,"url":703,"hash":704,"mime":45,"name":705,"path":12,"size":706,"width":707,"height":708},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Fmedium_Magnifying_Square_3f7ec0439b.jpg","medium_Magnifying_Square_3f7ec0439b","medium_Magnifying - Square.jpg",13.32,750,555,{"ext":42,"url":710,"hash":711,"mime":45,"name":712,"path":12,"size":713,"width":125,"height":49},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Fthumbnail_Magnifying_Square_3f7ec0439b.jpg","thumbnail_Magnifying_Square_3f7ec0439b","thumbnail_Magnifying - Square.jpg",2.51,"Magnifying_Square_3f7ec0439b",23.88,"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002FMagnifying_Square_3f7ec0439b.jpg","strapi-provider-upload-strapi-cloud","2024-02-01T14:25:02.722Z","2026-03-26T10:54:36.928Z","bos2gh0kpdwap4wultxjd0ta",{"__component":458,"id":722,"title":12,"content":723,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":106,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":724},3420,"### En dehors de celles-ci\nvoici quelques autres questions que nous recevons fréquemment concernant les réglementations et les directives relatives à la conformité des températures :",[725,729,733,737,741,745],{"id":726,"question":727,"answer":728},24098,"Qu'est-ce que la conformité des températures et pourquoi est-elle importante ?","La conformité des températures englobe l'ensemble des tâches qualité visant à garantir que les produits sensibles à la température, tels que les médicaments, sont stockés, manipulés et transportés dans des plages de température spécifiques. Cela inclut la [surveillance des températures](\u002Ftemperature-monitoring), la [cartographie thermique](\u002Ftemperature-mapping) et l'[étalonnage](\u002Ftemperature-calibration), et revêt une importance cruciale dans des secteurs tels que la pharmacie, la biotechnologie, les soins de santé, la logistique pharmaceutique et autres, afin de préserver l'intégrité, l'efficacité et la sécurité des produits, car de nombreux produits peuvent être affectés négativement par des variations de température.",{"id":730,"question":731,"answer":732},24099,"Comment la surveillance, la cartographie et l'étalonnage des températures contribuent-ils à la conformité ?","La surveillance des températures fournit des données en temps réel sur les conditions environnementales, garantissant ainsi un stockage sécurisé des produits. La cartographie thermique valide que les environnements de stockage respectent de manière constante les spécifications requises. L'étalonnage assure la précision des équipements utilisés pour la surveillance et la cartographie, contribuant ainsi à la fiabilité des données.",{"id":734,"question":735,"answer":736},24100,"Quelles sont les différences entre les réglementations, les normes et les directives en matière de conformité des températures ?","Les réglementations sont des exigences légales applicables en vertu de la loi. Les normes sont des références établies par consensus entre experts, souvent volontaires sauf si elles sont intégrées dans des réglementations. Les directives sont des bonnes pratiques ou des recommandations émanant d'organismes faisant autorité.\n",{"id":738,"question":739,"answer":740},24101,"Qu'est-ce que la norme ISO 17025 et quel est son lien avec le contrôle de la température ?","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) est la norme internationale applicable aux laboratoires d'étalonnage et d'essai, attestant de leur compétence et de la qualité de leurs étalonnages. Elle garantit que les laboratoires respectent des normes rigoureuses en matière de précision et de fiabilité des mesures de température, entre autres.",{"id":742,"question":743,"answer":744},24102,"À quelle fréquence convient-il d'effectuer une cartographie des températures pour rester en conformité avec les réglementations ?","La fréquence de votre cartographie de température dépend de plusieurs facteurs, allant de la nature des produits stockés à la stabilité de l'environnement et, bien entendu, des exigences réglementaires. \n\nLes réglementations varient selon le secteur et la localisation, mais en règle générale, vous devez effectuer des cartographies des nouveaux équipements ainsi que des recartographies régulières. \n\n[En savoir plus sur la fréquence à laquelle vous devez réaliser une cartographie de température](\u002Ftemperature-mapping)",{"id":746,"question":747,"answer":748},24103,"Comment la solution de conformité de température d'Eupry peut-elle vous aider à respecter les normes réglementaires ?","Nous sommes ravis que vous posiez la question. \n\n[La solution de conformité de température d'Eupry](\u002Four-solution) repose sur l'idéologie selon laquelle la conformité de température ne devrait pas être complexe. Elle intègre la surveillance, la cartographie et l'étalonnage dans une solution unique et numérique. \n\n**La solution :**\n- supprime les tâches et processus redondants.\n- minimise le travail manuel et les erreurs qui en découlent.\n- vous offre une source unique de vérité pour toutes les données (des relevés de température aux rapports d'écart et aux certificats d'étalonnage).\n- assure une surveillance en temps réel.\n- vous permet de générer des rapports prêts pour les audits en trois clics.\n\nEt bien plus encore. \n\n[Obtenez un catalogue de solutions pour en savoir plus](#catalogDownload)\n",{"__component":20,"id":750,"title":751,"content":752,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":753,"media":754,"employee":12},21868,"Ce que nous avons appris","Des directives de la FDA aux normes ISO, la gestion des exigences en matière de conformité de température est essentielle — non seulement pour des raisons de conformité, mais aussi pour garantir l'intégrité des produits et échantillons sensibles à la température dans des secteurs tels que la logistique de santé, la pharmacie et la biotechnologie.\n\nPour ce faire, une approche proactive est indispensable. Lorsque les auditeurs frappent à votre porte, il sera très probablement trop tard. \n\nHeureusement, les avancées technologiques ont considérablement simplifié ce processus.\n\nLes [systèmes de surveillance](\u002Ftemperature-monitoring\u002Fsystems) et solutions modernes automatisent et rationalisent le contrôle de la température et les démarches qualité, rendant le respect des exigences réglementaires non seulement plus fiable, mais aussi plus efficace. Certaines solutions unifient également des processus auparavant cloisonnés (c'est précisément ce que nous faisons), éliminant ainsi le risque que des tâches importantes passent entre les mailles du filet et engendrent des problèmes ultérieurs.",[],{"id":755,"name":756,"alternativeText":757,"caption":12,"width":38,"height":39,"formats":758,"hash":782,"ext":42,"mime":45,"size":783,"url":784,"previewUrl":12,"provider":717,"provider_metadata":12,"createdAt":785,"updatedAt":786,"documentId":787,"publishedAt":60,"focalPoint":12},493,"ChecklistLayoutSquare.jpg","Isometric illustration of a clipboard with a checklist, showing four checked boxes and one unchecked box with text lines",{"large":759,"small":765,"medium":771,"thumbnail":777},{"ext":42,"url":760,"hash":761,"mime":45,"name":762,"path":12,"size":763,"width":693,"height":764},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Flarge_Checklist_Layout_Square_85fcd61bed.jpg","large_Checklist_Layout_Square_85fcd61bed","large_ChecklistLayoutSquare.jpg",23.76,754,{"ext":42,"url":766,"hash":767,"mime":45,"name":768,"path":12,"size":769,"width":700,"height":770},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Fsmall_Checklist_Layout_Square_85fcd61bed.jpg","small_Checklist_Layout_Square_85fcd61bed","small_ChecklistLayoutSquare.jpg",8.66,377,{"ext":42,"url":772,"hash":773,"mime":45,"name":774,"path":12,"size":775,"width":707,"height":776},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Fmedium_Checklist_Layout_Square_85fcd61bed.jpg","medium_Checklist_Layout_Square_85fcd61bed","medium_ChecklistLayoutSquare.jpg",15.73,565,{"ext":42,"url":778,"hash":779,"mime":45,"name":780,"path":12,"size":781,"width":48,"height":49},"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002Fthumbnail_Checklist_Layout_Square_85fcd61bed.jpg","thumbnail_Checklist_Layout_Square_85fcd61bed","thumbnail_ChecklistLayoutSquare.jpg",2.25,"Checklist_Layout_Square_85fcd61bed",29.84,"https:\u002F\u002Fuseful-spirit-ce54045004.media.strapiapp.com\u002FChecklist_Layout_Square_85fcd61bed.jpg","2024-01-31T14:44:47.711Z","2026-03-26T10:54:12.283Z","elljdxdg5649l21o5dvv7ekc",{"__component":164,"id":789,"title":790,"lead":791,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":792,"card":797},1007,"3 endroits pour approfondir le sujet","### 1. Parlez à un expert (gratuitement)\nVous vous sentez submergé par les réglementations ? Ne vous inquiétez pas, notre équipe est là pour vous aider. Réservez une consultation gratuite de 15 minutes avec l'un de nos spécialistes en conformité.\n",[793],{"id":794,"title":795,"href":796,"type":31,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},20277,"Réserver une réunion maintenant","\u002Fbook-price-talk",[798,804],{"id":799,"title":800,"lead":801,"linkTitle":802,"href":803,"blockId":12},554,"2. En savoir plus","Explorez la conformité en matière de température en consultant nos articles. Téléchargez notre liste de contrôle en 9 étapes pour la conformité FDA et notre guide en 6 étapes pour réduire les tâches manuelles. Découvrez également comment maîtriser la surveillance de la température.","Lire nos articles","\u002Farticles",{"id":708,"title":805,"lead":806,"linkTitle":807,"href":808,"blockId":12},"3. Visionner davantage","Découvrez nos sessions vidéo à la demande qui couvrent tout, de la compréhension des fondamentaux de la 21 CFR Part 11 pour la surveillance des températures aux stratégies pertinentes pour automatiser entièrement vos processus de conformité en matière de température.","Visionner les sessions de formation","\u002Fwebinars",{},{"data":811,"meta":822},{"id":5,"documentId":10,"slug":7,"locale":11,"category":12,"localizations":812},[813,816,819],{"id":814,"documentId":10,"slug":815,"locale":91,"category":12},3815,"normative-conformita-temperatura",{"id":817,"documentId":10,"slug":818,"locale":84,"category":12},3758,"vorschriften-zur-temperaturkonformitaet",{"id":820,"documentId":10,"slug":821,"locale":77,"category":12},2206,"regulations-temperature-compliance",{},{"data":824,"meta":1255},{"id":820,"title":825,"slug":821,"createdAt":826,"updatedAt":827,"publishedAt":828,"documentId":10,"locale":77,"showOnArticlesPage":12,"disablePrerender":12,"prerenderTranslation":12,"category":12,"tagCategory":12,"blogImage":12,"settings":12,"seo":829,"body":833},"Pillar - Regulations temperature compliance","2024-01-09T14:54:37.338Z","2026-01-21T19:04:43.901Z","2026-01-21T19:24:33.655Z",{"id":830,"pageTitle":831,"shortDescription":832,"noIndex":13,"noAI":13,"noFollow":13,"Schema":12,"canonicalURL":12,"ogTitle":12,"ogDescription":12,"noSitemap":12,"schemaType":12,"image":12},2860,"Key regulations of temperature compliance","Master temperature compliance in pharmaceutical, biotech, and logistics. Discover key regulations, guidelines, and practical solutions.",[834,874,879,883,885,895,908,916,926,928,933,942,944,949,962,972,982,995,1005,1015,1025,1038,1041,1084,1086,1099,1118,1123,1133,1174,1184,1186,1197,1225,1236],{"__component":20,"id":835,"title":831,"content":836,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":24,"preTitleColor":12,"ctaInfoText":12,"titleLevel":25,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":837,"media":841,"employee":846},9756,"Are you spending too much time navigating regulations, yet remaining worried that you are not living up to _all_ the requirements and following _all_ the standards you should?\n\nWhen working in highly regulated industries like pharma, biotech, and healthcare logistics, maneuvering the **temperature compliance** landscape can be a struggle.\n\nLuckily, we have got you covered.\n\nLet us run through the compliance areas you _should_ be familiar with when working with temperature control – from [monitoring](\u002Ftemperature-monitoring) to [mapping](\u002Ftemperature-mapping) and [calibration](\u002Ftemperature-calibration) –  to help you navigate them confidently.\n\n",[838],{"id":839,"title":840,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10069,"Automate temperature compliance with Eupry",{"id":35,"name":36,"alternativeText":37,"caption":12,"width":38,"height":39,"formats":842,"hash":52,"ext":42,"mime":45,"size":53,"url":54,"previewUrl":12,"provider":55,"provider_metadata":845,"createdAt":57,"updatedAt":58,"documentId":59,"publishedAt":60,"focalPoint":12},{"thumbnail":843},{"ext":42,"url":43,"hash":44,"mime":45,"name":46,"path":12,"size":47,"width":48,"height":49,"provider_metadata":844},{"public_id":44,"resource_type":51},{"public_id":52,"resource_type":51},{"id":72,"name":63,"workTitle":73,"testimonial":12,"email":12,"linkedIn":65,"createdAt":74,"updatedAt":75,"publishedAt":76,"documentId":68,"locale":77,"url":69,"image":847,"thumbnail":12,"localizations":870},{"id":848,"name":849,"alternativeText":850,"caption":12,"width":851,"height":852,"formats":853,"hash":862,"ext":42,"mime":45,"size":863,"url":864,"previewUrl":12,"provider":55,"provider_metadata":865,"createdAt":866,"updatedAt":867,"documentId":868,"publishedAt":869,"focalPoint":12},1142,"Jakob.jpg","Headshot of Jakob, a bearded man with glasses wearing a light blue shirt, against a neutral background.",400,582,{"thumbnail":854},{"ext":42,"url":855,"hash":856,"mime":45,"name":857,"path":12,"size":858,"width":859,"height":49,"sizeInBytes":860,"provider_metadata":861},"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1747924743\u002Fthumbnail_Jakob_c5bef4b1d7.jpg","thumbnail_Jakob_c5bef4b1d7","thumbnail_Jakob.jpg",3.46,107,3457,{"public_id":856,"resource_type":51},"Jakob_c5bef4b1d7",119.58,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1747924743\u002FJakob_c5bef4b1d7.jpg",{"public_id":862,"resource_type":51},"2025-05-22T14:39:03.832Z","2026-03-26T11:01:59.654Z","g5thni2w7vy0tqc3xlci6vc9","2025-05-22T14:39:03.833Z",[871,872,873],{"id":62,"name":63,"workTitle":64,"testimonial":12,"email":12,"linkedIn":65,"createdAt":66,"updatedAt":66,"publishedAt":67,"documentId":68,"locale":11,"url":69},{"id":79,"name":63,"workTitle":80,"testimonial":12,"email":12,"linkedIn":65,"createdAt":81,"updatedAt":82,"publishedAt":83,"documentId":68,"locale":84,"url":69},{"id":86,"name":63,"workTitle":87,"testimonial":12,"email":12,"linkedIn":65,"createdAt":88,"updatedAt":89,"publishedAt":90,"documentId":68,"locale":91,"url":69},{"__component":20,"id":875,"title":876,"content":877,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":878,"media":12,"employee":12},9747,"On this page, you can explore:","- [What is temperature compliance?](#whatIsTemperatureCompliance)\n- [Why are regulations necessary for temperature compliance?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Regulations, standards and guidelines – is there a difference?](#regulationsStandardsGuidelines)\n- [The key regulations and standards of temperature compliance](#understandingKeyRegulationsAndStandards)\n- [3 steps to implementing compliance in your operations](#3stepsToImplementingComplianceInYourOperations)\n- [How technology can make temperature compliance a non-issue](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 frequent temperature compliance issues (and their solutions)](#8frequentTemperatureComplianceIssues)\n- [Frequently asked questions about temperature compliance](#faq)",[],{"__component":99,"id":880,"title":881,"content":882,"blockId":12,"imageUrl":12,"hideOnMobile":12,"textColumns":12,"titleLevel":12,"media":12},548,"Not just temperature","Although temperature is our favorite child (and subsequently the focus of this page), many of the regulations and other compliance components are equally relevant to monitoring, mapping, and calibration related to **humidity**, **CO2**, **differential pressure**, and other environmental parameters.",{"__component":104,"id":884,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},8466,{"__component":20,"id":886,"title":887,"content":888,"blockId":111,"ulStyle":12,"video":12,"auto play":13,"imageLeftTextRight":13,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":889,"media":890,"employee":12},9748,"What is temperature compliance?","In the world of pharma, drug distribution, and biotech, there are many different regulatory fields, and even if you work with quality, you might not have come across the phrase very often.\n\n**Nevertheless, the concept holds the potential to considerably optimize the way we work with temperature-related compliance issues within GxP.**\n\n**The short version:** Temperature compliance consolidates the quality tasks intended to ensure that temperature-sensitive products and samples are handled within specific temperature ranges during production, storage, and transport.\n\n**It compiles three main disciplines:**\n- Temperature monitoring\n- Validation and temperature mapping\n- Calibration of [data loggers](\u002Fsolutions\u002Fwireless-data-loggers) or sensors\n",[],{"id":114,"name":115,"alternativeText":116,"caption":12,"width":117,"height":118,"formats":891,"hash":128,"ext":42,"mime":45,"size":129,"url":130,"previewUrl":12,"provider":55,"provider_metadata":894,"createdAt":132,"updatedAt":133,"documentId":134,"publishedAt":135,"focalPoint":12},{"thumbnail":892},{"ext":42,"url":121,"hash":122,"mime":45,"name":123,"path":12,"size":124,"width":125,"height":49,"sizeInBytes":126,"provider_metadata":893},{"public_id":122,"resource_type":51},{"public_id":128,"resource_type":51},{"__component":20,"id":896,"title":897,"content":898,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":899,"media":903,"employee":12},9757,"Why temperature compliance should be handled as one","In most organizations, the domains of temperature compliance are handled more or less independently and by different departments operating independently with their own budgets on their own tasks, objectives, and priorities.\n\n**But this is both inefficient and risky.**\n\nThese disconnected processes not only leave room for unnecessary, double efforts, bottlenecks, and idle time – they leave room for things falling between the chairs.\n\nIn other words, when monitoring, calibration, and mapping are not unified, you both risk having inefficient work processes and leave your compliance position vulnerable.\n\nOn the other hand, unifying lets you streamline processes, integrate data, improve efficiency, and mitigate risks.",[900],{"id":901,"title":902,"href":144,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10070,"How to unify temperature compliance",{"id":146,"name":147,"alternativeText":148,"caption":12,"width":38,"height":39,"formats":904,"hash":156,"ext":42,"mime":45,"size":157,"url":158,"previewUrl":12,"provider":55,"provider_metadata":907,"createdAt":160,"updatedAt":161,"documentId":162,"publishedAt":60,"focalPoint":12},{"thumbnail":905},{"ext":42,"url":151,"hash":152,"mime":45,"name":153,"path":12,"size":154,"width":48,"height":49,"provider_metadata":906},{"public_id":152,"resource_type":51},{"public_id":156,"resource_type":51},{"__component":164,"id":909,"title":166,"lead":910,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":911,"card":915},693,"Eupry’s temperature compliance solution secures compliance and control of **_all_** your temperature-related quality efforts.",[912],{"id":913,"title":914,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10071,"See how it works",[],{"__component":174,"id":917,"title":918,"content":919,"video":12,"blockId":178,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":920,"media":921,"employee":12},2515,"Why are regulations necessary for temperature compliance?","This is probably a no-brainer, but worth underlining nonetheless: Temperature compliance regulations are not there to make our work more time-consuming, complex, and frustrating (but let us be honest, it can often feel like it). Their sole purpose is to ensure that products remain effective and safe.\n\nIn healthcare logistics, pharma, biotech, and similar industries, a large range of products and samples are highly sensitive to even small temperature deviations. As a result, meticulous [temperature monitoring](\u002Ftemperature-monitoring) and [mapping](\u002Ftemperature-mapping) are needed to secure quality. Regulations, standards, and guidelines are in place to ensure these processes are done correctly, ultimately safeguarding the integrity and safety of these vital products.",[],{"id":181,"name":182,"alternativeText":183,"caption":12,"width":184,"height":185,"formats":922,"hash":195,"ext":42,"mime":45,"size":196,"url":197,"previewUrl":12,"provider":55,"provider_metadata":925,"createdAt":199,"updatedAt":200,"documentId":201,"publishedAt":60,"focalPoint":12},{"thumbnail":923},{"ext":42,"url":188,"hash":189,"mime":45,"name":190,"path":12,"size":191,"width":192,"height":193,"provider_metadata":924},{"public_id":189,"resource_type":51},{"public_id":195,"resource_type":51},{"__component":104,"id":927,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},8467,{"__component":174,"id":929,"title":930,"content":931,"video":12,"blockId":208,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":932,"media":12,"employee":12},2516,"Regulations, standards, and guidelines – is there a difference?","In the quality context, **standards**, **guidelines**, and **regulations** each play their specific role in shaping practices and procedures – and compliance in highly regulated industries often involves adhering to a combination of all three elements to ensure safety and efficacy.\n\nThis section explores the different definitions and use cases for these principles:",[],{"__component":20,"id":934,"title":12,"content":935,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":936,"media":937,"employee":12},9749,"## Regulations in temperature compliance:\n- **Definition:** Regulations are legal requirements created by governmental bodies or regulatory agencies. They are mandatory and enforceable by law.\n- **Characteristics:** Regulations are often specific, providing detailed instructions or criteria that must be followed. They are legally binding, and non-compliance can result in legal penalties, including fines or sanctions.\n- **Examples:** In the context of temperature mapping and monitoring, regulations might be issued by entities like the [FDA](https:\u002F\u002Fwww.fda.gov\u002F) (U.S. Food and Drug Administration), [EMA](https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fhomepage) (European Medicines Agency), or other relevant national health authorities.\n\n## Standards in temperature compliance:\n- **Definition:** Standards are established by consensus among experts in a field and are often developed by standard-setting organizations, both international and national, such as the International Organization for Standardization [ISO](https:\u002F\u002Fwww.iso.org\u002Fhome.html) or the American National Standards Institute [ANSI](https:\u002F\u002Fansi.org\u002F).\n- **Characteristics:** Standards provide guidelines for practices, ensuring quality, safety, and efficiency. They are generally voluntary unless adopted by a regulatory body into a regulation. Compliance with standards is often necessary for market acceptance, certification, and sometimes regulatory compliance.\n- **Examples:** ISO 9001 for quality management systems or [ISO 17025](\u002Fregulations-temperature-compliance\u002FIso-17025) for the competence of testing and calibration laboratories are standards that, while voluntary, are widely recognized and adhered to in pharma, biotech, and healthcare logistics industries.\n\n## Guidelines in temperature compliance:\n- **Definition:** Guidelines are sets of recommendations or best practices proposed by organizations, often based on research and expert consensus. They are not legally enforceable but are meant to guide industry professionals in specific areas of their work.\n- **Characteristics:** Guidelines are usually more flexible than regulations or standards, offering recommendations rather than strict rules. They are designed to help organizations achieve better outcomes but do not carry the weight of the law.\n- **Examples:** [Good Manufacturing Practice (GMP)](\u002Fregulations-temperature-compliance\u002Fgmp) guidelines provide frameworks for manufacturers to ensure products are consistently produced and controlled according to quality standards, and [Good Distribution Practice (GDP)](\u002Fgdp) guidelines ensure that the quality and integrity of products are maintained during storage and transportation. Note that, while these guidelines are not laws in themselves, they are often based on regulations.\n\n**To sum up:**\nRegulations are legally binding and must be followed, standards are voluntary benchmarks that can become mandatory when adopted by a regulatory body, and guidelines are advisory, providing best practices to achieve the best results. \n",[],{"id":215,"name":216,"alternativeText":217,"caption":12,"width":38,"height":218,"formats":938,"hash":227,"ext":42,"mime":45,"size":228,"url":229,"previewUrl":12,"provider":55,"provider_metadata":941,"createdAt":231,"updatedAt":232,"documentId":233,"publishedAt":60,"focalPoint":12},{"thumbnail":939},{"ext":42,"url":221,"hash":222,"mime":45,"name":223,"path":12,"size":224,"width":225,"height":49,"provider_metadata":940},{"public_id":222,"resource_type":51},{"public_id":227,"resource_type":51},{"__component":104,"id":943,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},8468,{"__component":237,"id":945,"title":946,"lead":947,"blockId":241,"ulStyle":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"imageUrl":12,"subTitle":12,"hideOnMobile":12,"ulColor":12,"hideLastUpdated":12,"buttons":948,"image":12,"employee":12},1318,"Understanding key regulations and standards of temperature compliance","Let us turn our attention to the specific regulations, standards, and guidelines relevant to your [temperature monitoring](\u002Ftemperature-monitoring), [mapping](\u002Ftemperature-mapping), and [calibration](\u002Ftemperature-calibration\u002Four-calibration-solution) procedures. \n\n**Disclaimer:** The following is a summary of standards commonly associated with temperature compliance initiatives. Please note that the specific standards applicable to your operations will vary based on your industry, the nature of your products, your clientele, and other relevant considerations.",[],{"__component":20,"id":950,"title":951,"content":952,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":953,"media":957,"employee":12},9758,"FDA 21 CFR Part 11 – the digital compliance cornerstone","[21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11) is a **regulation** that outlines the criteria under which electronic signatures and records – here among digital temperature records – can be considered trustworthy and reliable.\nIt is part of the Code of Federal Regulations (CFR) established by the United States Food and Drug Administration (FDA). \n\n**Who is it relevant for?**\n\nThe 21 CFR Part 11 regulation is relevant for companies involved in regulated industries such as pharmaceutical and biotechnology, that in any way operate in the US (partners, clients, distribution – it all counts), and utilize digital temperature monitoring systems – or simply keep some digital version of temperature records for compliance. So, pretty much everyone working with temperature-sensitive products.\nLearn more about FDA 21 CFR Part 11. ",[954],{"id":955,"title":956,"href":251,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10072,"Learn more about FDA 21 CFR Part 11",{"id":253,"name":254,"alternativeText":255,"caption":12,"width":256,"height":257,"formats":958,"hash":266,"ext":42,"mime":45,"size":267,"url":268,"previewUrl":12,"provider":55,"provider_metadata":961,"createdAt":270,"updatedAt":271,"documentId":272,"publishedAt":60,"focalPoint":12},{"thumbnail":959},{"ext":42,"url":260,"hash":261,"mime":45,"name":262,"path":12,"size":263,"width":192,"height":264,"provider_metadata":960},{"public_id":261,"resource_type":51},{"public_id":266,"resource_type":51},{"__component":274,"id":963,"title":964,"lead":965,"hubspotFormId":966,"blockId":279,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":967},2566,"FDA 21 CFR Part 11 compliance checklist","Simplify 21 CFR Part 11 compliance for your temperature monitoring with our 9-step checklist.","4a62bd09-760d-4591-993e-fc0e2a0a8e01",{"id":281,"name":282,"alternativeText":283,"caption":12,"width":284,"height":285,"formats":968,"hash":296,"ext":288,"mime":291,"size":297,"url":298,"previewUrl":12,"provider":55,"provider_metadata":971,"createdAt":300,"updatedAt":301,"documentId":302,"publishedAt":60,"focalPoint":12},{"thumbnail":969},{"ext":288,"url":289,"hash":290,"mime":291,"name":292,"path":12,"size":293,"width":294,"height":49,"provider_metadata":970},{"public_id":290,"resource_type":51},{"public_id":296,"resource_type":51},{"__component":20,"id":973,"title":974,"content":975,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":976,"media":977,"employee":12},9750,"FDA 21 CFR Part 211 – requirements for manufacturing pharmaceuticals","The FDA’s 21 CFR Part **211** (not to be mistaken with Part 11, although, we see how that might happen) is titled \"Current Good Manufacturing Practice for Finished Pharmaceuticals.\"\n\nThis **regulation** covers the current Good Manufacturing Practice (cGMP) – the minimum requirements – for the methods, facilities, and controls used in the manufacture, processing, packing, or holding of a drug product to ensure that it meets quality standards and is safe for use. \n\n**Who is it relevant for?**\n\nThis regulation is relevant for pharmaceutical manufacturers in the United States. It ensures that pharmaceutical products are produced under appropriate environmental conditions, including temperature control, to ensure their safety, purity, and efficacy\n",[],{"id":309,"name":310,"alternativeText":311,"caption":12,"width":38,"height":218,"formats":978,"hash":319,"ext":42,"mime":45,"size":320,"url":321,"previewUrl":12,"provider":55,"provider_metadata":981,"createdAt":323,"updatedAt":324,"documentId":325,"publishedAt":60,"focalPoint":12},{"thumbnail":979},{"ext":42,"url":314,"hash":315,"mime":45,"name":316,"path":12,"size":317,"width":225,"height":49,"provider_metadata":980},{"public_id":315,"resource_type":51},{"public_id":319,"resource_type":51},{"__component":20,"id":983,"title":984,"content":985,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":986,"media":990,"employee":12},9759,"ISO 17025 – the benchmark for calibration and testing laboratories","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) is the international standard for the competence of [calibration](\u002Ftemperature-calibration\u002Four-calibration-solution) laboratories. In other words, an ISO 17025 accreditation is a stamp of quality showing that a calibration lab lives up to the highest international standards for precision.\n\nThe standard is created by the International Organization for Standardization – [ISO](https:\u002F\u002Fwww.iso.org\u002Fabout-us.html) – an independent, non-governmental organization with 169 national standards bodies as members, each representing ISO in their respective country. The organization develops a wide range of proprietary, industrial, and commercial standards to ensure quality, safety, and efficiency across industries.\n\n**Who is it relevant for?**\n\nThe standard is relevant for laboratories conducting calibration of temperature and humidity instruments to ensure accuracy and reliability in measurements.\n\nFor companies that do not have in-house calibration, an ISO 17025 accreditation might be relevant when looking for calibration suppliers or pre-calibrated [data loggers](\u002Fdata-logger) for temperature monitoring or mapping.\n\nThe need for ISO 17025-accredited vs. for instance traceable calibration largely depends on the industry's regulatory conditions, the criticality of accurate measurements in operations, and the requirements of customers. \n\nFor non-critical measurements, low-risk industries, internal quality control, and alike, traceable calibration might be sufficient, but for strictly regulated industries with sensitive products, ISO 17025-accredited calibration is often required. \n",[987],{"id":988,"title":989,"href":334,"type":31,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10073,"Learn more about ISO 17025-accredited calibration",{"id":337,"name":338,"alternativeText":339,"caption":12,"width":256,"height":257,"formats":991,"hash":348,"ext":42,"mime":45,"size":349,"url":350,"previewUrl":12,"provider":55,"provider_metadata":994,"createdAt":352,"updatedAt":353,"documentId":354,"publishedAt":60,"focalPoint":12},{"thumbnail":992},{"ext":42,"url":342,"hash":343,"mime":45,"name":344,"path":12,"size":345,"width":192,"height":264,"sizeInBytes":346,"provider_metadata":993},{"public_id":343,"resource_type":51},{"public_id":348,"resource_type":51},{"__component":20,"id":996,"title":997,"content":998,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":999,"media":1000,"employee":12},9751,"ISO 9001 – the stamp of quality management approval","ISO 9001 is a globally recognized standard for quality management systems (QMS). \n\nIt sets out the criteria for a QMS to ensure the consistent quality of products and services to meet both customer and regulatory requirements.\n\nThe standard is based on a range of different quality management principles, including customer focus, the involvement of company management, a process approach, and continual improvement.\n\nFor temperature compliance, the role of ISO 9001 is to ensure processes for temperature control are reliably managed and continuously improved, meeting industry standards. Whether it is ensuring the efficacy of pharmaceuticals or the reliability of medical devices, ISO 9001 lays the foundation for maintaining high-quality standards in temperature-sensitive operations.\n\n**Who is it relevant for?**\n\nThe ISO 9001 standard is deliberately designed to be so general that almost all organizations can recognize themselves and utilize it to improve quality. It especially creates great value for organizations in industries where delivering consistent quality is vital. It applies to for instance pharmaceutical companies, biotech firms, medical device manufacturers, and any business involved in the lifecycle of health-related products.",[],{"id":361,"name":362,"alternativeText":363,"caption":12,"width":256,"height":257,"formats":1001,"hash":371,"ext":42,"mime":45,"size":372,"url":373,"previewUrl":12,"provider":55,"provider_metadata":1004,"createdAt":375,"updatedAt":376,"documentId":377,"publishedAt":60,"focalPoint":12},{"thumbnail":1002},{"ext":42,"url":366,"hash":367,"mime":45,"name":368,"path":12,"size":369,"width":192,"height":264,"provider_metadata":1003},{"public_id":367,"resource_type":51},{"public_id":371,"resource_type":51},{"__component":20,"id":1006,"title":1007,"content":1008,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1009,"media":1010,"employee":12},9752,"GxP – the umbrella of good practices","GxP encompasses a range of compliance guidelines such as [Good Manufacturing Practices (GMP)](\u002Fregulations-temperature-compliance\u002Fgmp\u002F), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and [Good Distribution Practices (GDP)](\u002Fgdp).\n\nThese guidelines are essential in ensuring that products are safe, meet their intended use, and adhere to quality processes throughout their lifecycle. In the pharmaceutical context, GxP forms the foundation for regulating drug development and manufacturing.\n\n**Also see**: [AI in GxP: What's working and what's risky](\u002Fai)\n\n**Who is it relevant for?**\n\nDifferent variations of [GxP](\u002Fregulations-temperature-compliance\u002Fgxp\u002F) guidelines are relevant for a broad range of organizations in sectors where quality and temperature compliance are critical – pharmaceutical companies, biotech organizations, clinical research, healthcare providers, laboratories, and logistics and distribution, especially when managing pharmaceutical products.\n\n**Also see**: [How to meet GMP temperature requirements](\u002Fregulations-temperature-compliance\u002Fgmp\u002F)",[],{"id":384,"name":385,"alternativeText":386,"caption":12,"width":38,"height":39,"formats":1011,"hash":394,"ext":42,"mime":45,"size":395,"url":396,"previewUrl":12,"provider":55,"provider_metadata":1014,"createdAt":398,"updatedAt":399,"documentId":400,"publishedAt":60,"focalPoint":12},{"thumbnail":1012},{"ext":42,"url":389,"hash":390,"mime":45,"name":391,"path":12,"size":392,"width":48,"height":49,"provider_metadata":1013},{"public_id":390,"resource_type":51},{"public_id":394,"resource_type":51},{"__component":20,"id":1016,"title":1017,"content":1018,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1019,"media":1020,"employee":12},9753,"USP \u003C1079> – guidelines for temperature-controlled storage and distribution","USP \u003C1079> is a guideline developed by the United States Pharmacopeia (USP) – a scientific, non-profit organization that sets federally recognized, public standards for medicines, supplements, and food ingredients.\n\nIt outlines best practices for the storage and distribution of pharmaceutical products under controlled temperature conditions, maintaining product integrity throughout the supply chain and focusing on temperature monitoring, control, and documentation.\n\n**Who is it relevant for?**\n\nUSP \u003C1079> is applicable for organizations involved in the pharmaceutical supply chain, including manufacturers, distributors, and storage facilities. It is particularly relevant for entities handling temperature-sensitive pharmaceuticals, where maintaining specific environmental conditions is essential for product efficacy and safety.\n\nWhile USP \u003C1079>  is specifically tailored for the pharmaceutical industry, the principles outlined in the guideline can be informative for other industries that handle sensitive products.\n",[],{"id":407,"name":408,"alternativeText":409,"caption":12,"width":256,"height":257,"formats":1021,"hash":417,"ext":42,"mime":45,"size":418,"url":419,"previewUrl":12,"provider":55,"provider_metadata":1024,"createdAt":421,"updatedAt":422,"documentId":423,"publishedAt":60,"focalPoint":12},{"thumbnail":1022},{"ext":42,"url":412,"hash":413,"mime":45,"name":414,"path":12,"size":415,"width":192,"height":264,"provider_metadata":1023},{"public_id":413,"resource_type":51},{"public_id":417,"resource_type":51},{"__component":20,"id":1026,"title":1027,"content":1028,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1029,"media":1033,"employee":12},9760,"WHO – a world of mapping guidelines","The World Health Organization (WHO), an international guardian of public health, provides guidelines for safeguarding health supplies worldwide. These guidelines are designed to manage the complex process of storing and transporting health products across diverse climates.\n\nSelecting the relevant WHO guidelines for you depends on your specific organizational needs and the nature of the products you handle – but [Supplement 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002FAnnex-9-f-trs-961): “Qualification of temperature-controlled storage areas”, [Supplement 8](https:\u002F\u002Fcdn.who.int\u002Fmedia\u002Fdocs\u002Fdefault-source\u002Fmedicines\u002Fnorms-and-standards\u002Fguidelines\u002Fdistribution\u002Ftrs961-annex9-supp8.pdf?sfvrsn=fb423ff8_2&download=true): “Temperature mapping of storage areas”, and [Annex 8](https:\u002F\u002Fwww.who.int\u002Fdocs\u002Fdefault-source\u002Fmedicines\u002Fnorms-and-standards\u002Fguidelines\u002Fproduction\u002Ftrs1010-annex8-who-gmp-heating-ventilation-airconditioning.pdf?sfvrsn=c77698e2_0): “Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products offer targeted advice for different scenarios in temperature mapping.\n\n**Who is it relevant for?**\n\nThe WHO guidelines in Supplement 7, Supplement 8, and Annex 8 are relevant for any sector managing the storage, handling, and distribution of temperature-sensitive products, ensuring product integrity and safety – from pharmaceutical companies to healthcare logistics organizations.\n\nThe guidelines are just that, guidelines, and not formal standards or regulations. But, although not legally required, they represent best practices and can be used as a guiding principle to secure the reliability of your [temperature mapping studies](\u002Ftemperature-mapping). Also, as the WHO is a respected authority on health globally and its guidelines are considered well-founded, the guidelines are often used as a basis for national regulations.\n\n[Read our full guide to the WHO's temperature mapping guides](\u002Ftemperature-mapping\u002Fwho-mapping-guidelines\u002F)",[1030],{"id":1031,"title":1032,"href":432,"type":31,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10074,"Read our WHO mapping guide",{"id":434,"name":435,"alternativeText":436,"caption":12,"width":256,"height":257,"formats":1034,"hash":444,"ext":42,"mime":45,"size":445,"url":446,"previewUrl":12,"provider":55,"provider_metadata":1037,"createdAt":448,"updatedAt":449,"documentId":450,"publishedAt":60,"focalPoint":12},{"thumbnail":1035},{"ext":42,"url":439,"hash":440,"mime":45,"name":441,"path":12,"size":442,"width":192,"height":264,"provider_metadata":1036},{"public_id":440,"resource_type":51},{"public_id":444,"resource_type":51},{"__component":452,"id":1039,"text":454,"columns":455,"title":12,"blockId":12,"hideOnMobile":12,"ulStyle":12,"ulColor":12,"withBackground":12,"buttons":1040},2690,[],{"__component":458,"id":1042,"title":1043,"content":461,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":106,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":1044},1646,"Other relevant standards and guidelines",[1045,1049,1053,1057,1061,1065,1068,1071,1074,1078,1081],{"id":1046,"question":1047,"answer":1048},10635,"WHO guidelines for good storage practices","The “[TRS 1025 - Annex 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002Ftrs-1025-annex-7)” is a worldwide guideline emphasizing the correct storage conditions, including temperature requirements, for medical products.",{"id":1050,"question":1051,"answer":1052},10636,"ICH Q10 (Pharmaceutical Quality System)","Encompasses the entire pharmaceutical lifecycle, integrating Good Manufacturing Practices (GMPs) with quality systems and risk management.",{"id":1054,"question":1055,"answer":1056},10637,"EU Annex 11 (Europe)","Similar to [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11), EU Annex 11 focuses on digital records. It covers how records in the pharmaceutical sector, including those related to temperature control, should be managed to ensure their integrity, reliability, and compliance with EU regulations.",{"id":1058,"question":1059,"answer":1060},10638,"EU GMP Annex 15","This deals with the qualification and validation of processes and systems used in pharmaceutical manufacturing; including making sure that [temperature monitoring systems](\u002Ftemperature-monitoring\u002Fsystems) are qualified and validated. The focus is on the physical aspects and performance of equipment and processes to ensure they are fit for the intended use and meet defined specifications.",{"id":1062,"question":1063,"answer":1064},10639,"EudraLex Volume 4 (EU)","This provides directives for the manufacturing, importation, and distribution of medicinal products in the EU.",{"id":1066,"question":485,"answer":1067},10640,"A standard developed by [ASTM International](https:\u002F\u002Fwww.astm.org\u002F), providing a guide for the specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment, covering, among other aspects, temperature control.",{"id":1069,"question":489,"answer":1070},10641,"Requirements for temperature recorders used in the transport, storage, and distribution of temperature-sensitive food products.",{"id":1072,"question":493,"answer":1073},10642,"Evaluates the effectiveness of antimicrobial handwashing formulations, where controlled temperature during testing is crucial.",{"id":1075,"question":1076,"answer":1077},10643,"ASHRAE Standards","Guidelines for HVAC systems, essential in maintaining controlled temperatures in facilities.",{"id":1079,"question":501,"answer":1080},10644,"Comprehensive guide to steam sterilization in healthcare facilities, where temperature control is vital for sterility.",{"id":1082,"question":505,"answer":1083},10645,"Quality control for commercially prepared microbiological culture media, emphasizing temperature control during preparation and storage.",{"__component":104,"id":1085,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},8469,{"__component":510,"id":1087,"title":1088,"content":1089,"blockId":12,"imageUrl":12,"hideOnMobile":12,"buttons":1090,"backgroundImage":1094},338,"That was a lot… ","**Luckily, not all regulations apply to your operations.**\n\n**So which do? Our compliance specialists are ready to help (no strings attached).**",[1091],{"id":1092,"title":1093,"href":518,"type":519,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10075,"Book a 15 -minute free consultation",{"id":521,"name":522,"alternativeText":523,"caption":12,"width":184,"height":524,"formats":1095,"hash":533,"ext":42,"mime":45,"size":534,"url":535,"previewUrl":12,"provider":55,"provider_metadata":1098,"createdAt":537,"updatedAt":538,"documentId":539,"publishedAt":60,"focalPoint":12},{"thumbnail":1096},{"ext":42,"url":527,"hash":528,"mime":45,"name":529,"path":12,"size":530,"width":192,"height":531,"provider_metadata":1097},{"public_id":528,"resource_type":51},{"public_id":533,"resource_type":51},{"__component":541,"id":1100,"title":1101,"lead":1102,"iconStyle":545,"withBackground":106,"blockId":546,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":1103},1795,"3 steps to implementing compliance in your operations","We have gone through a myriad of regulations and compliance requirements for temperature control of pharmaceutical and other temperature-sensitive products and samples.\nNow, how do you keep auditors happy and incorporate the relevant rules and best practices into your operations?\nNo size fits everyone, but there are three main fields to consider: \n",[1104,1109,1114],{"id":1105,"title":1106,"lead":1107,"icon":552,"linkTitle":1108,"linkHref":554,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9905,"Using a (compliant) temperature monitoring system","Implementing a reliable temperature monitoring system and utilizing it compliantly is essential for temperature compliance. The systems should provide real-time monitoring, data logging, and instant alerting to maintain the integrity of sensitive products.","What to look for",{"id":1110,"title":1111,"lead":1112,"icon":559,"linkTitle":1113,"linkHref":561,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9906,"Performing regular temperature mappings","Temperature mapping is used to validate that storage environments consistently meet the required temperature specifications – and performing them is part of regulations for most industries working with temperature-sensitive products. It involves a detailed analysis of temperature distribution within a storage area, ensuring uniformity and identifying any potential problem areas.","How to perform a compliant mapping",{"id":1115,"title":1116,"lead":1117,"icon":566,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9907,"Using calibrated equipment","The foundation of reliable measurement. Regular calibration of temperature monitoring equipment is necessary for compliance in most industries. It ensures the accuracy of data loggers and sensors and the reliability of data.",{"__component":174,"id":1119,"title":1120,"content":1121,"video":12,"blockId":12,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":1122,"media":12,"employee":12},2517,"Naturally,","this overview does not include every aspect of ensuring temperature compliance for your organization. However, these three areas – monitoring, mapping, and calibration – form the pillars of temperature compliance, and implementing reliable systems and processes for all three can work as a framework for developing a compliant setup.\n\n**Next up, how technology can help make this much simpler.**",[],{"__component":274,"id":1124,"title":1125,"lead":1126,"hubspotFormId":1127,"blockId":577,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":1128},2567,"Automated temperature compliance in one place","Temperature compliance should not be hard.\n\nBe in full control of your temperature compliance at all times. Collect [monitoring](\u002Ftemperature-monitoring\u002Four-monitoring-solution\u002F), [mapping](\u002Ftemperature-mapping\u002Four-mapping-solution\u002F), and [calibration](\u002Ftemperature-calibration\u002Four-calibration-solution\u002F) in one GxP-compliant solution.","76bf4d75-d529-402d-85d6-200a1bf95457",{"id":579,"name":580,"alternativeText":581,"caption":12,"width":582,"height":583,"formats":1129,"hash":592,"ext":288,"mime":291,"size":593,"url":594,"previewUrl":12,"provider":55,"provider_metadata":1132,"createdAt":596,"updatedAt":597,"documentId":598,"publishedAt":60,"focalPoint":12},{"thumbnail":1130},{"ext":288,"url":586,"hash":587,"mime":291,"name":588,"path":12,"size":589,"width":590,"height":49,"provider_metadata":1131},{"public_id":587,"resource_type":51},{"public_id":592,"resource_type":51},{"__component":541,"id":1134,"title":1135,"lead":1136,"iconStyle":603,"withBackground":13,"blockId":604,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":1137},1796,"How technology can make temperature compliance a non-issue","Navigating temperature compliance means navigating a comprehensive range of regulations, standards, and guidelines, which can be confusing and overwhelming.\n\nLuckily, over the last years, technical advancements and [digital monitoring solutions](\u002Ftemperature-monitoring\u002Fsystems) have emerged, designed to make compliance a non-issue for the users.\n",[1138,1142,1146,1150,1154,1158,1162,1166,1170],{"id":1139,"title":1140,"lead":1141,"icon":610,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9908,"Live and automated temperature tracking","to enable immediate action on deviations.",{"id":1143,"title":1144,"lead":1145,"icon":615,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9909,"Advanced alarms","providing customizable alerts, filtering out grey zones, and tailoring notifications based on specific compliance needs.",{"id":1147,"title":1148,"lead":1149,"icon":620,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9910,"Automated deviation logging","making registration, analysis, and reporting of excursions more efficient.",{"id":1151,"title":1152,"lead":1153,"icon":625,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9911,"Audit-ready reports","generated with only a few clicks to simplify audits.",{"id":1155,"title":1156,"lead":1157,"icon":630,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9912,"A single database","with \u003Cu>all\u003C\u002Fu> temperature data accessible in one place, including alarms, calibration certificates, and mapping protocols.",{"id":1159,"title":1160,"lead":1161,"icon":566,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9913,"Calibration management","not only tracking calibration certificates but also schedules.",{"id":1163,"title":1164,"lead":1165,"icon":639,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9914,"Compliance-specific features","like modules designed for [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11).",{"id":1167,"title":1168,"lead":1169,"icon":644,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9915,"Varying levels of flexibility","in temperature thresholds to match your regulatory requirements.",{"id":1171,"title":1172,"lead":1173,"icon":649,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9916,"And more","Some solutions also include access to specialist support who can provide guidance and support on your compliance issues.\n\nIn other words, modern solutions can be used to automate and streamline – and automating means removing manual mistakes and misalignments in record-keeping, making compliance more reliable.\n\n",{"__component":274,"id":1175,"title":1176,"lead":1177,"hubspotFormId":1178,"blockId":655,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":1179},2568,"Checklist: 8 frequent temperature compliance issues"," **(and their solutions)**\nTemperature compliance is complex, and, as a result, mistakes happen. Dive into the most common issues of temperature compliance - and how you can avoid them.","d3f1159f-ee0c-4d7e-9230-c489c0ba5912",{"id":657,"name":658,"alternativeText":659,"caption":12,"width":284,"height":285,"formats":1180,"hash":667,"ext":288,"mime":291,"size":668,"url":669,"previewUrl":12,"provider":55,"provider_metadata":1183,"createdAt":671,"updatedAt":672,"documentId":673,"publishedAt":60,"focalPoint":12},{"thumbnail":1181},{"ext":288,"url":662,"hash":663,"mime":291,"name":664,"path":12,"size":665,"width":294,"height":49,"provider_metadata":1182},{"public_id":663,"resource_type":51},{"public_id":667,"resource_type":51},{"__component":104,"id":1185,"divider":106,"blockId":12,"hideOnMobile":12,"spacing":12},8470,{"__component":20,"id":1187,"title":1188,"content":1189,"blockId":680,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1190,"media":1191,"employee":12},9754,"Frequently asked questions about temperature compliance","We have already covered some of the most common questions about regulations and compliance for temperature monitoring, thermal mapping, and calibration. \n\n- [What is temperature compliance?](#whatIsTemperatureCompliance)\n- [Why are regulations necessary for temperature compliance?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Regulations, standards and guidelines – is there a difference?](#regulationsStandardsGuidelines)\n- [Understanding key regulations and standards of temperature compliance](#understandingKeyRegulationsAndStandards)\n- [3 steps to implementing compliance in your operations](#3stepsToImplementingComplianceInYourOperations)\n- [How technology can make temperature compliance a non-issue](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 frequent temperature compliance issues (and their solutions)](#7frequentTemperatureComplianceIssues)\n- [Frequently asked questions about temperature compliance](#faq)\n",[],{"id":683,"name":684,"alternativeText":685,"caption":12,"width":38,"height":686,"formats":1192,"hash":714,"ext":42,"mime":45,"size":715,"url":716,"previewUrl":12,"provider":717,"provider_metadata":12,"createdAt":718,"updatedAt":719,"documentId":720,"publishedAt":60,"focalPoint":12},{"large":1193,"small":1194,"medium":1195,"thumbnail":1196},{"ext":42,"url":689,"hash":690,"mime":45,"name":691,"path":12,"size":692,"width":693,"height":694},{"ext":42,"url":696,"hash":697,"mime":45,"name":698,"path":12,"size":699,"width":700,"height":701},{"ext":42,"url":703,"hash":704,"mime":45,"name":705,"path":12,"size":706,"width":707,"height":708},{"ext":42,"url":710,"hash":711,"mime":45,"name":712,"path":12,"size":713,"width":125,"height":49},{"__component":458,"id":1198,"title":12,"content":1199,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":106,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":1200},1647,"### Besides these\nhere are some other questions we often get about regulations and guidelines for temperature compliance:",[1201,1205,1209,1213,1217,1221],{"id":1202,"question":1203,"answer":1204},10646,"What is temperature compliance and why is it important?","Temperature compliance encompasses all the quality tasks aimed at ensuring that temperature-sensitive products, like pharmaceuticals, are stored, handled, and transported within specific temperature ranges. This includes [temperature monitoring](\u002Ftemperature-monitoring), [thermal mapping](\u002Ftemperature-mapping), and [calibration](\u002Ftemperature-calibration), and is crucial in sectors like pharma, biotech, healthcare, pharmaceutical logistics, and alike to maintain product integrity, effectiveness, and safety, as many products can be adversely affected by temperature variations.",{"id":1206,"question":1207,"answer":1208},10647,"How do temperature monitoring, mapping, and calibration contribute to compliance?","Temperature monitoring provides real-time data on the environmental conditions, ensuring products are stored safely. Temperature mapping validates that storage environments consistently meet required specifications. Calibration ensures the accuracy of equipment used in monitoring and mapping, contributing to reliable data.",{"id":1210,"question":1211,"answer":1212},10648,"What are the differences between regulations, standards, and guidelines in temperature compliance?","Regulations are legal requirements enforceable by law. Standards are benchmarks established by consensus among experts, often voluntary unless adopted into regulations. Guidelines are best practices or recommendations from authoritative bodies.\n",{"id":1214,"question":1215,"answer":1216},10649,"What is ISO 17025 and how does it relate to temperature control?","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) is the international standard for calibration and testing laboratories, signifying their competence and the quality of their calibrations. It ensures that labs follow rigorous standards for accuracy and reliability in – among others – temperature measurements.",{"id":1218,"question":1219,"answer":1220},10650,"How often should you perform temperature mapping to keep up with regulations?","The frequency of your temperature mapping depends on several things, from the nature of the stored products to the stability of the environment and, of course, regulatory requirements. \n\nRegulations vary by industry and location, but as a general rule, you need to perform mappings of new equipment as well as regular remappings. \n\n[Learn more about how often you need to conduct temperature mapping](\u002Ftemperature-mapping)",{"id":1222,"question":1223,"answer":1224},10651,"How can Eupry’s temperature compliance solution help you meet regulatory standards?","We are so glad you asked. \n\n[Eupry’s temperature compliance solution](\u002Four-solution) is built on the ideology that temperature compliance should not be hard. It integrates monitoring, mapping, and calibration in one, digital solution. \n\n**The solution:**\n- removes redundant tasks and processes.\n- minimizes manual work and the shadowing mistakes.\n- gives you a single source of truth for all data (from temperature records to deviation reports and calibration certificates).\n- provides real-time monitoring\n- lets you generate audit-ready reports in three clicks.\n\nAnd much more. \n\n[Get a solution catalog to learn more](#catalogDownload)\n",{"__component":20,"id":1226,"title":1227,"content":1228,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":96,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1229,"media":1230,"employee":12},9755,"What we have learned","From FDA guidelines to ISO standards, managing the requirements of temperature compliance is essential – not only for the sake of compliance, but to secure the integrity of the vital, temperature-sensitive products and samples in industries like healthcare logistics, pharma, and biotech.\n\nFor this, a proactive approach is key. When the auditors knock on your door, it will most likely be too late. \n\nLuckily, technological advances have made the process much simpler.\n\nModern [monitoring systems](\u002Ftemperature-monitoring\u002Fsystems) and solutions automate and streamline temperature control and quality efforts to make the process of keeping up with regulatory requirements not only more reliable but also more efficient. Some solutions also unify previously siloed processes (yes, we do that), removing the risk of important tasks falling between chairs and subsequent issues.",[],{"id":755,"name":756,"alternativeText":757,"caption":12,"width":38,"height":39,"formats":1231,"hash":782,"ext":42,"mime":45,"size":783,"url":784,"previewUrl":12,"provider":717,"provider_metadata":12,"createdAt":785,"updatedAt":786,"documentId":787,"publishedAt":60,"focalPoint":12},{"large":1232,"small":1233,"medium":1234,"thumbnail":1235},{"ext":42,"url":760,"hash":761,"mime":45,"name":762,"path":12,"size":763,"width":693,"height":764},{"ext":42,"url":766,"hash":767,"mime":45,"name":768,"path":12,"size":769,"width":700,"height":770},{"ext":42,"url":772,"hash":773,"mime":45,"name":774,"path":12,"size":775,"width":707,"height":776},{"ext":42,"url":778,"hash":779,"mime":45,"name":780,"path":12,"size":781,"width":48,"height":49},{"__component":164,"id":1237,"title":1238,"lead":1239,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":1240,"card":1244},694,"3 places to dive deeper","### 1. Talk to an expert (for free)\nFeeling swamped by regulations? Don't worry, our team is here to help. Book a free 15-minute consultation with one of our compliance specialists.\n",[1241],{"id":1242,"title":1243,"href":796,"type":31,"size":32,"arrow":335,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10076,"Book a meeting now",[1245,1250],{"id":1246,"title":1247,"lead":1248,"linkTitle":1249,"href":803,"blockId":12},454,"2. Read more","Explore temperature compliance by checking out our articles. Download our 9-step FDA compliance checklist and our 6-step guide to reduce manual tasks. Also, discover how to master temperature monitoring.","Read our articles",{"id":1251,"title":1252,"lead":1253,"linkTitle":1254,"href":808,"blockId":12},455,"3. 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Le même matériel pour la surveillance et la cartographie.","\u002Fsolutions\u002Fsensors",{"id":1721,"title":1722,"createdAt":1723,"updatedAt":1723,"publishedAt":1724,"link":1725,"order":1514,"documentId":1726,"locale":11,"submenu":1727},111,"Produits","2026-07-26T17:56:04.805Z","2026-07-26T17:56:04.839Z","\u002Fproducts\u002F","iozurp0tpkq8tsan1yt9pzdh",[],{"id":193,"title":1729,"createdAt":1730,"updatedAt":1730,"publishedAt":1731,"link":12,"order":1534,"documentId":1732,"locale":11,"submenu":1733},"Cas d'usage","2026-07-26T17:56:05.625Z","2026-07-26T17:56:05.660Z","qewu04orvxevg5vn13wkq6fq",[1734],{"__component":1735,"id":1736,"title":12,"menuItem":1737},"navigation.submenu",75,[1738,1742,1744,1747,1750,1754,1758],{"id":1739,"title":1740,"icon":1329,"topBorder":12,"link":1741,"blockId":12,"lucideIcon":12},613,"Études de cas","\u002Fcases",{"id":1743,"title":1729,"icon":1338,"topBorder":12,"link":1457,"blockId":12,"lucideIcon":12},614,{"id":1745,"title":1746,"icon":335,"topBorder":106,"link":12,"blockId":12,"lucideIcon":12},615,"Industries",{"id":1748,"title":1460,"icon":1460,"topBorder":12,"link":1749,"blockId":12,"lucideIcon":12},616,"\u002Findustries\u002Fpharma\u002F",{"id":1751,"title":1752,"icon":1753,"topBorder":12,"link":1469,"blockId":12,"lucideIcon":12},617,"Logistique","Logistics",{"id":1755,"title":1756,"icon":1464,"topBorder":12,"link":1757,"blockId":12,"lucideIcon":12},618,"Biotechnologie","\u002Findustries\u002Fbiotech\u002F",{"id":1759,"title":1760,"icon":1761,"topBorder":12,"link":1762,"blockId":12,"lucideIcon":12},619,"Laboratoires","Laboratory","\u002Findustries\u002Flaboratories\u002F",{"id":1764,"title":1765,"createdAt":1766,"updatedAt":1766,"publishedAt":1767,"link":12,"order":1553,"documentId":1768,"locale":11,"submenu":1769},117,"Connaissances","2026-07-26T17:56:06.264Z","2026-07-26T17:56:06.307Z","whg5ji10iuvn13a2alpippex",[1770],{"__component":1647,"id":1771,"columns":1772},36,[1773,1803,1836],{"id":1774,"label":1652,"blocks":1775},106,[1776],{"__component":1655,"id":1774,"title":1777,"items":1778},"Lignes directrices pour",[1779,1784,1789,1794,1799],{"id":1780,"title":1781,"description":1782,"link":1783,"tag":12,"tagColor":1670},442,"Systèmes de surveillance","Bonnes pratiques et caractéristiques clés pour choisir un système de surveillance de la température en GxP.","\u002Ftemperature-monitoring\u002F",{"id":1785,"title":1786,"description":1787,"link":1788,"tag":12,"tagColor":1670},443,"Cartographie de la température","Conseils, cadres méthodologiques et écueils courants de la cartographie de la température en GxP.","\u002Ftemperature-mapping\u002F",{"id":1790,"title":1791,"description":1792,"link":1793,"tag":12,"tagColor":1670},444,"Cartographie continue","Le cadre, les principaux avantages et les étapes pour intégrer la cartographie continue à vos opérations.","\u002Ftemperature-mapping\u002Fcontinuous-temperature-mapping",{"id":1795,"title":1796,"description":1797,"link":1798,"tag":12,"tagColor":1670},445,"Choisir des enregistreurs de données","Les critères à prendre en compte lors du choix d'enregistreurs de données pour les BPx – fonctionnalités, types et comparatifs.","\u002Fdata-logger\u002F",{"id":1800,"title":1801,"description":1802,"link":1395,"tag":12,"tagColor":1670},446,"Étalonnage de température","Méthodes, normes et procédures d'étalonnage dans le cadre des BPx. 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