[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fMnjvvwPmicx4jc2Ys9Blal5c-SCJLWznFaqnnC7DVt4":3,"localizations-u7ca1f2v3guei9dnsq7wcqra-de":384,"pages-en-fallback-u7ca1f2v3guei9dnsq7wcqra":392,"global-seo-setting":1128,"header-setting-de":1175,"navigations-de":1234,"footer-de":1492,"localizations-pages-u7ca1f2v3guei9dnsq7wcqra-de":1605,"certificates":1610},{"data":4,"meta":383},{"id":5,"title":6,"slug":7,"createdAt":8,"updatedAt":8,"publishedAt":9,"documentId":10,"locale":11,"showOnArticlesPage":12,"disablePrerender":12,"category":12,"tagCategory":12,"blogImage":12,"settings":12,"seo":13,"body":18},2986,"Säule - Vorschriften zur Temperaturkonformität","vorschriften-zur-temperaturkonformitaet","2026-06-03T09:19:14.234Z","2026-06-03T09:19:15.146Z","u7ca1f2v3guei9dnsq7wcqra","de",null,{"id":14,"pageTitle":15,"shortDescription":16,"noIndex":17,"noAI":17,"noFollow":17,"Schema":12,"canonicalURL":12,"ogTitle":12,"ogDescription":12,"noSitemap":12,"image":12},3924,"Wichtige Vorschriften zur Temperaturkonformität","Meistern Sie die Temperaturkonformität in der Pharmazie, Biotechnologie und Logistik. Entdecken Sie wichtige Vorschriften, Richtlinien und praktische Lösungen.",false,[19,33,39,44,48,54,63,73,80,82,88,92,94,101,110,117,122,132,137,142,147,156,162,212,214,225,252,257,263,314,320,322,328,356,361],{"__component":20,"id":21,"title":15,"content":22,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":23,"preTitleColor":12,"ctaInfoText":12,"titleLevel":24,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":25,"media":12,"employee":12},"blocks.media-and-text-split-view",14202,"Verbringen Sie zu viel Zeit damit, sich durch Vorschriften zu navigieren, und sind dennoch besorgt, dass Sie nicht _allen_ Anforderungen gerecht werden und _alle_ Standards einhalten, die Sie einhalten sollten?\n\nWenn Sie in stark regulierten Branchen wie Pharma, Biotechnologie und Healthcare-Logistik tätig sind, kann die Navigation der **Temperatur-Compliance**-Landschaft eine Herausforderung sein.\n\nGlücklicherweise haben wir die Lösung für Sie.\n\nLassen Sie uns die Compliance-Bereiche durchgehen, mit denen Sie _vertraut sein sollten_, wenn Sie mit Temperaturkontrolle arbeiten – vom [Monitoring](\u002Ftemperature-monitoring) über das [Mapping](\u002Ftemperature-mapping) bis zur [Kalibrierung](\u002Ftemperature-calibration) –, damit Sie sicher durch diese navigieren können.\n\n"," ","h1",[26],{"id":27,"title":28,"href":29,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13746,"Temperatur-Compliance mit Eupry automatisieren","\u002Four-solution","black","default","right",{"__component":20,"id":34,"title":35,"content":36,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":38,"media":12,"employee":12},14193,"Auf dieser Seite können Sie erkunden:","- [Was ist Temperatur-Compliance?](#whatIsTemperatureCompliance)\n- [Warum sind Vorschriften für die Temperatur-Compliance notwendig?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Vorschriften, Standards und Richtlinien – gibt es einen Unterschied?](#regulationsStandardsGuidelines)\n- [Die wichtigsten Vorschriften und Standards der Temperatur-Compliance](#understandingKeyRegulationsAndStandards)\n- [3 Schritte zur Implementierung von Compliance in Ihren Betrieb](#3stepsToImplementingComplianceInYourOperations)\n- [Wie Technologie die Temperatur-Compliance zum Selbstläufer machen kann](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 häufige Probleme bei der Temperatur-Compliance (und ihre Lösungen)](#8frequentTemperatureComplianceIssues)\n- [Häufig gestellte Fragen zur Temperatur-Compliance](#faq)","h2",[],{"__component":40,"id":41,"title":42,"content":43,"blockId":12,"imageUrl":12,"hideOnMobile":12,"media":12},"blocks.media-and-text-overflow-media",734,"Nicht nur Temperatur","Obwohl Temperatur unser Lieblingsthema ist (und dementsprechend der Schwerpunkt dieser Seite), sind viele der Vorschriften und anderen Compliance-Komponenten gleichermaßen relevant für Monitoring, Mapping und Kalibrierung in Bezug auf **Luftfeuchtigkeit**, **CO2**, **Differenzdruck** und andere Umgebungsparameter.",{"__component":45,"id":46,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},"blocks.divider",15359,true,{"__component":20,"id":49,"title":50,"content":51,"blockId":52,"ulStyle":12,"video":12,"auto play":17,"imageLeftTextRight":17,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":53,"media":12,"employee":12},14194,"Was ist Temperatur-Compliance?","In der Welt der Pharmaindustrie, des Arzneimittelvertriebs und der Biotechnologie gibt es viele verschiedene regulatorische Bereiche, und selbst wenn Sie im Qualitätswesen tätig sind, sind Sie möglicherweise nicht oft auf diesen Begriff gestoßen.\n\n**Dennoch birgt das Konzept das Potenzial, die Art und Weise, wie wir mit temperaturbezogenen Compliance-Fragen innerhalb von GxP arbeiten, erheblich zu optimieren.**\n\n**Kurz zusammengefasst:** Temperatur-Compliance bündelt die Qualitätsaufgaben, die sicherstellen sollen, dass temperaturempfindliche Produkte und Proben während Produktion, Lagerung und Transport innerhalb bestimmter Temperaturbereiche gehandhabt werden.\n\n**Sie umfasst drei Hauptdisziplinen:**\n- Temperaturmonitoring\n- Validierung und Temperature Mapping\n- Kalibrierung von [Datenloggern](\u002Fsolutions\u002Fwireless-data-loggers) oder Sensoren\n","whatIsTemperatureCompliance",[],{"__component":20,"id":55,"title":56,"content":57,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":58,"media":12,"employee":12},14203,"Warum Temperatur-Compliance als Einheit behandelt werden sollte","In den meisten Organisationen werden die Bereiche der Temperatur-Compliance mehr oder weniger unabhängig voneinander und von verschiedenen Abteilungen verwaltet, die eigenständig mit eigenen Budgets, Aufgaben, Zielen und Prioritäten arbeiten.\n\n**Dies ist jedoch sowohl ineffizient als auch risikoreich.**\n\nDiese voneinander getrennten Prozesse lassen nicht nur Raum für unnötige Doppelarbeit, Engpässe und Leerlaufzeiten – sie lassen auch Raum dafür, dass Dinge zwischen den Stühlen fallen.\n\nMit anderen Worten: Wenn Monitoring, Kalibrierung und Mapping nicht vereinheitlicht sind, riskieren Sie sowohl ineffiziente Arbeitsprozesse als auch eine anfällige Compliance-Position.\n\nEine Vereinheitlichung hingegen ermöglicht es Ihnen, Prozesse zu straffen, Daten zu integrieren, die Effizienz zu steigern und Risiken zu minimieren.",[59],{"id":60,"title":61,"href":62,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13747,"Wie man die Temperatur-Compliance vereinheitlicht","\u002Fregulations-temperature-compliance\u002Funify-temperature-compliance",{"__component":64,"id":65,"title":66,"lead":67,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":68,"card":72},"blocks.call-to-action",797,"Psst...","Euprys Temperatur-Compliance-Lösung sichert die Einhaltung und Kontrolle **_aller_** Ihrer temperaturbezogenen Qualitätsbemühungen.",[69],{"id":70,"title":71,"href":29,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13748,"So funktioniert es",[],{"__component":74,"id":75,"title":76,"content":77,"video":12,"blockId":78,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":79,"media":12,"employee":12},"blocks.media-and-text",3841,"Warum sind Vorschriften für die Temperatur-Compliance notwendig?","Dies ist wahrscheinlich selbstverständlich, aber dennoch erwähnenswert: Temperatur-Compliance-Vorschriften sind nicht dazu da, unsere Arbeit zeitaufwändiger, komplexer und frustrierender zu machen (aber seien wir ehrlich, es kann sich oft so anfühlen). Ihr einziger Zweck besteht darin, sicherzustellen, dass Produkte wirksam und sicher bleiben.\n\nIn der Gesundheitslogistik, der Pharma-, Biotech- und ähnlichen Branchen reagiert eine Vielzahl von Produkten und Proben äußerst empfindlich auf selbst geringfügige Temperaturschwankungen. Daher sind eine sorgfältige [Temperaturüberwachung](\u002Ftemperature-monitoring) und [Temperaturkartierung](\u002Ftemperature-mapping) erforderlich, um die Qualität zu sichern. Vorschriften, Normen und Leitlinien sind vorhanden, um sicherzustellen, dass diese Prozesse korrekt durchgeführt werden und letztlich die Integrität und Sicherheit dieser wichtigen Produkte gewährleistet ist.","whyAreRegulationsNecessaryForTemperatureCompliance",[],{"__component":45,"id":81,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},15360,{"__component":74,"id":83,"title":84,"content":85,"video":12,"blockId":86,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":87,"media":12,"employee":12},3842,"Vorschriften, Normen und Leitlinien – gibt es einen Unterschied?","Im Qualitätskontext spielen **Normen**, **Leitlinien** und **Vorschriften** jeweils eine spezifische Rolle bei der Gestaltung von Praktiken und Verfahren – und die Compliance in stark regulierten Branchen erfordert häufig die Einhaltung einer Kombination aller drei Elemente, um Sicherheit und Wirksamkeit zu gewährleisten.\n\nDieser Abschnitt erläutert die verschiedenen Definitionen und Anwendungsfälle dieser Grundsätze:","regulationsStandardsGuidelines",[],{"__component":20,"id":89,"title":12,"content":90,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":91,"media":12,"employee":12},14195,"## Vorschriften in der Temperatur-Compliance:\n- **Definition:** Vorschriften sind gesetzliche Anforderungen, die von staatlichen Stellen oder Regulierungsbehörden erlassen werden. Sie sind verbindlich und rechtlich durchsetzbar.\n- **Merkmale:** Vorschriften sind häufig spezifisch und enthalten detaillierte Anweisungen oder Kriterien, die eingehalten werden müssen. Sie sind rechtlich bindend, und bei Nichteinhaltung können rechtliche Sanktionen, einschließlich Bußgelder oder Strafen, verhängt werden.\n- **Beispiele:** Im Kontext der Temperaturkartierung und -überwachung können Vorschriften von Behörden wie der [FDA](https:\u002F\u002Fwww.fda.gov\u002F) (U.S. Food and Drug Administration), der [EMA](https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fhomepage) (Europäische Arzneimittel-Agentur) oder anderen zuständigen nationalen Gesundheitsbehörden erlassen werden.\n\n## Normen in der Temperatur-Compliance:\n- **Definition:** Normen werden durch Konsens unter Fachleuten eines Bereichs festgelegt und häufig von nationalen und internationalen Normungsorganisationen entwickelt, wie der International Organization for Standardization [ISO](https:\u002F\u002Fwww.iso.org\u002Fhome.html) oder dem American National Standards Institute [ANSI](https:\u002F\u002Fansi.org\u002F).\n- **Merkmale:** Normen bieten Leitlinien für Praktiken und gewährleisten Qualität, Sicherheit und Effizienz. Sie sind grundsätzlich freiwillig, sofern sie nicht von einer Regulierungsbehörde in eine Vorschrift übernommen werden. Die Einhaltung von Normen ist häufig für die Marktakzeptanz, Zertifizierung und mitunter auch für die regulatorische Compliance erforderlich.\n- **Beispiele:** ISO 9001 für Qualitätsmanagementsysteme oder [ISO 17025](\u002Fregulations-temperature-compliance\u002FIso-17025) für die Kompetenz von Prüf- und Kalibrierlaboratorien sind Normen, die zwar freiwillig sind, aber in der Pharma-, Biotech- und Gesundheitslogistikbranche weithin anerkannt und eingehalten werden.\n\n## Leitlinien in der Temperatur-Compliance:\n- **Definition:** Leitlinien sind Empfehlungen oder Best Practices, die von Organisationen vorgeschlagen werden und häufig auf Forschungsergebnissen und Expertenkonsens basieren. Sie sind rechtlich nicht durchsetzbar, sollen jedoch Fachleute der Branche in bestimmten Bereichen ihrer Arbeit anleiten.\n- **Merkmale:** Leitlinien sind in der Regel flexibler als Vorschriften oder Normen und bieten Empfehlungen anstelle strenger Regeln. Sie sollen Organisationen dabei helfen, bessere Ergebnisse zu erzielen, haben jedoch keine Gesetzeskraft.\n- **Beispiele:** Die Leitlinien zur [Guten Herstellungspraxis (GMP)](\u002Fregulations-temperature-compliance\u002Fgmp) bieten Herstellern Rahmenbedingungen, um sicherzustellen, dass Produkte konsistent nach Qualitätsstandards produziert und kontrolliert werden, und die Leitlinien zur [Guten Vertriebspraxis (GDP)](\u002Fgdp) gewährleisten, dass Qualität und Integrität der Produkte während Lagerung und Transport erhalten bleiben. Es sei darauf hingewiesen, dass diese Leitlinien zwar keine Gesetze an sich sind, jedoch häufig auf Vorschriften basieren.\n\n**Zusammenfassend lässt sich sagen:**\nVorschriften sind rechtlich bindend und müssen eingehalten werden, Normen sind freiwillige Benchmarks, die bei Übernahme durch eine Regulierungsbehörde verbindlich werden können, und Leitlinien sind empfehlender Natur und bieten Best Practices zur Erzielung optimaler Ergebnisse.\n",[],{"__component":45,"id":93,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},15361,{"__component":95,"id":96,"title":97,"lead":98,"blockId":99,"ulStyle":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"imageUrl":12,"subTitle":12,"hideOnMobile":12,"ulColor":12,"hideLastUpdated":12,"buttons":100,"image":12,"employee":12},"blocks.hero",1556,"Wichtige Vorschriften und Normen der Temperatur-Compliance im Ueberblick","Lassen Sie uns einen Blick auf die spezifischen Vorschriften, Normen und Leitlinien werfen, die für Ihre Verfahren zur [Temperaturüberwachung](\u002Ftemperature-monitoring), [Temperaturkartierung](\u002Ftemperature-mapping) und [Kalibrierung](\u002Ftemperature-calibration\u002Four-calibration-solution) relevant sind. \n\n**Haftungsausschluss:** Das Folgende ist eine Zusammenfassung von Normen, die häufig mit Temperatur-Compliance-Initiativen in Verbindung gebracht werden. Bitte beachten Sie, dass die für Ihren Betrieb geltenden spezifischen Normen je nach Branche, Art Ihrer Produkte, Ihrer Kundschaft und anderen relevanten Faktoren variieren.","understandingKeyRegulationsAndStandards",[],{"__component":20,"id":102,"title":103,"content":104,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":105,"media":12,"employee":12},14204,"FDA 21 CFR Part 11 – der digitale Eckpfeiler der Compliance","[21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11) ist eine **Verordnung**, die die Kriterien festlegt, unter denen elektronische Signaturen und Aufzeichnungen – darunter auch digitale Temperaturaufzeichnungen – als vertrauenswürdig und zuverlässig angesehen werden können.\nSie ist Teil des Code of Federal Regulations (CFR), der von der United States Food and Drug Administration (FDA) herausgegeben wird. \n\n**Für wen ist sie relevant?**\n\nDie Verordnung 21 CFR Part 11 ist relevant für Unternehmen in regulierten Branchen wie der Pharma- und Biotechnologiebranche, die in irgendeiner Weise in den USA tätig sind (Partner, Kunden, Vertrieb – all das zählt) und digitale Temperaturüberwachungssysteme nutzen – oder schlicht digitale Temperaturaufzeichnungen zu Compliance-Zwecken führen. Das betrifft also nahezu alle Unternehmen, die mit temperatursensiblen Produkten arbeiten.\nErfahren Sie mehr über FDA 21 CFR Part 11. ",[106],{"id":107,"title":108,"href":109,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13749,"Mehr über FDA 21 CFR Part 11 erfahren","\u002Fregulations-temperature-compliance\u002F21-cfr-part-11",{"__component":111,"id":112,"title":113,"lead":114,"hubspotFormId":115,"blockId":116,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":12},"blocks.download-form",3364,"Compliance-Checkliste für FDA 21 CFR Part 11","Vereinfachen Sie die Einhaltung von 21 CFR Part 11 für Ihre Temperaturüberwachung mit unserer 9-Schritte-Checkliste.","4a62bd09-760d-4591-993e-fc0e2a0a8e01","fdaDownload",{"__component":20,"id":118,"title":119,"content":120,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":121,"media":12,"employee":12},14196,"FDA 21 CFR Part 211 – Anforderungen an die Herstellung von Arzneimitteln","Die FDA's 21 CFR Part **211** (nicht zu verwechseln mit Part 11, obwohl wir verstehen, wie das passieren kann) trägt den Titel „Current Good Manufacturing Practice for Finished Pharmaceuticals\".\n\nDiese **Verordnung** regelt die aktuellen Guten Herstellungspraktiken (cGMP) – die Mindestanforderungen – für die Methoden, Einrichtungen und Kontrollen, die bei der Herstellung, Verarbeitung, Verpackung oder Lagerung eines Arzneimittels eingesetzt werden, um sicherzustellen, dass es den Qualitätsstandards entspricht und sicher angewendet werden kann.\n\n**Für wen ist es relevant?**\n\nDiese Verordnung ist für Arzneimittelhersteller in den Vereinigten Staaten relevant. Sie stellt sicher, dass pharmazeutische Produkte unter geeigneten Umgebungsbedingungen, einschließlich Temperaturkontrolle, hergestellt werden, um ihre Sicherheit, Reinheit und Wirksamkeit zu gewährleisten.\n",[],{"__component":20,"id":123,"title":124,"content":125,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":126,"media":12,"employee":12},14205,"ISO 17025 – der Maßstab für Kalibrierungs- und Prüflaboratorien","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) ist die internationale Norm für die Kompetenz von [Kalibrierungs](\u002Ftemperature-calibration\u002Four-calibration-solution)laboratorien. Mit anderen Worten: Eine ISO 17025-Akkreditierung ist ein Qualitätssiegel, das belegt, dass ein Kalibrierlabor den höchsten internationalen Standards für Präzision entspricht.\n\nDie Norm wird von der International Organization for Standardization – [ISO](https:\u002F\u002Fwww.iso.org\u002Fabout-us.html) – entwickelt, einer unabhängigen, nicht-staatlichen Organisation mit 169 nationalen Normungsgremien als Mitglieder, die jeweils ISO in ihrem jeweiligen Land vertreten. Die Organisation entwickelt ein breites Spektrum an proprietären, industriellen und kommerziellen Normen, um Qualität, Sicherheit und Effizienz branchenübergreifend zu gewährleisten.\n\n**Für wen ist es relevant?**\n\nDie Norm ist relevant für Laboratorien, die Kalibrierungen von Temperatur- und Feuchtigkeitsmessgeräten durchführen, um die Genauigkeit und Zuverlässigkeit von Messungen sicherzustellen.\n\nFür Unternehmen ohne eigene Kalibrierungskapazitäten kann eine ISO 17025-Akkreditierung bei der Auswahl von Kalibrierungsdienstleistern oder vorkalibrierten [Datenloggern](\u002Fdata-logger) für die Temperaturüberwachung oder -kartierung von Bedeutung sein.\n\nOb eine ISO 17025-akkreditierte oder beispielsweise eine rückverfolgbare Kalibrierung erforderlich ist, hängt weitgehend von den regulatorischen Rahmenbedingungen der Branche, der Kritikalität präziser Messungen im Betrieb sowie den Anforderungen der Kunden ab.\n\nFür unkritische Messungen, risikoarme Branchen, interne Qualitätskontrolle und Ähnliches kann eine rückverfolgbare Kalibrierung ausreichend sein. In streng regulierten Branchen mit sensiblen Produkten ist jedoch häufig eine ISO 17025-akkreditierte Kalibrierung erforderlich.\n",[127],{"id":128,"title":129,"href":130,"type":30,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13750,"Mehr über ISO 17025-akkreditierte Kalibrierung erfahren","\u002Fregulations-temperature-compliance\u002Fiso-17025","none",{"__component":20,"id":133,"title":134,"content":135,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":136,"media":12,"employee":12},14197,"ISO 9001 – das Gütesiegel des Qualitätsmanagements","ISO 9001 ist ein weltweit anerkannter Standard für Qualitätsmanagementsysteme (QMS). \n\nEr legt die Kriterien für ein QMS fest, um eine gleichbleibende Qualität von Produkten und Dienstleistungen sicherzustellen und sowohl Kunden- als auch regulatorische Anforderungen zu erfüllen.\n\nDer Standard basiert auf einer Reihe verschiedener Qualitätsmanagementprinzipien, darunter Kundenorientierung, die Einbindung der Unternehmensleitung, ein prozessorientierter Ansatz und kontinuierliche Verbesserung.\n\nIm Bereich der Temperatur-Compliance hat ISO 9001 die Aufgabe sicherzustellen, dass Prozesse zur Temperaturkontrolle zuverlässig gesteuert und kontinuierlich verbessert werden und den Branchenstandards entsprechen. Ob es um die Wirksamkeit von Arzneimitteln oder die Zuverlässigkeit von Medizinprodukten geht – ISO 9001 legt das Fundament für die Aufrechterhaltung hoher Qualitätsstandards in temperatursensiblen Betriebsabläufen.\n\n**Für wen ist es relevant?**\n\nDer ISO 9001-Standard ist bewusst so allgemein gehalten, dass nahezu alle Organisationen sich darin wiederfinden und ihn zur Qualitätsverbesserung nutzen können. Er schafft insbesondere einen hohen Mehrwert für Organisationen in Branchen, in denen die Lieferung gleichbleibender Qualität von entscheidender Bedeutung ist. Er gilt beispielsweise für Pharmaunternehmen, Biotechnologieunternehmen, Medizinproduktehersteller und alle Unternehmen, die am Lebenszyklus gesundheitsbezogener Produkte beteiligt sind.",[],{"__component":20,"id":138,"title":139,"content":140,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":141,"media":12,"employee":12},14198,"GxP – der Oberbegriff der Good Practices","GxP umfasst eine Reihe von Compliance-Leitlinien wie [Good Manufacturing Practices (GMP)](\u002Fregulations-temperature-compliance\u002Fgmp\u002F), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) und [Good Distribution Practices (GDP)](\u002Fgdp).\n\nDiese Leitlinien sind unerlässlich, um sicherzustellen, dass Produkte sicher sind, ihrem vorgesehenen Verwendungszweck entsprechen und während ihres gesamten Lebenszyklus Qualitätsprozessen folgen. Im pharmazeutischen Kontext bildet GxP die Grundlage für die Regulierung der Arzneimittelentwicklung und -herstellung.\n\n**Siehe auch**: [KI in GxP: Was funktioniert und was ist riskant](\u002Fai)\n\n**Für wen ist es relevant?**\n\nVerschiedene Varianten der [GxP](\u002Fregulations-temperature-compliance\u002Fgxp\u002F)-Leitlinien sind für ein breites Spektrum von Organisationen in Sektoren relevant, in denen Qualität und Temperatur-Compliance entscheidend sind – Pharmaunternehmen, Biotechnologieorganisationen, klinische Forschung, Gesundheitsdienstleister, Laboratorien sowie Logistik und Distribution, insbesondere beim Umgang mit pharmazeutischen Produkten.\n\n**Siehe auch**: [So erfüllen Sie die GMP-Temperaturanforderungen](\u002Fregulations-temperature-compliance\u002Fgmp\u002F)",[],{"__component":20,"id":143,"title":144,"content":145,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":146,"media":12,"employee":12},14199,"USP \u003C1079> – Leitlinien für temperaturkontrollierte Lagerung und Distribution","USP \u003C1079> ist eine Richtlinie, die von der United States Pharmacopeia (USP) entwickelt wurde – einer wissenschaftlichen, gemeinnützigen Organisation, die bundesweit anerkannte, öffentliche Standards für Arzneimittel, Nahrungsergänzungsmittel und Lebensmittelzutaten festlegt.\n\nSie beschreibt bewährte Verfahren für die Lagerung und den Vertrieb von Arzneimitteln unter kontrollierten Temperaturbedingungen, wobei die Produktintegrität entlang der gesamten Lieferkette gewahrt wird und der Schwerpunkt auf Temperaturüberwachung, -kontrolle und -dokumentation liegt.\n\n**Für wen ist sie relevant?**\n\nUSP \u003C1079> gilt für Organisationen, die an der pharmazeutischen Lieferkette beteiligt sind, einschließlich Hersteller, Distributoren und Lagereinrichtungen. Sie ist besonders relevant für Unternehmen, die temperaturempfindliche Arzneimittel handhaben, bei denen die Einhaltung spezifischer Umgebungsbedingungen für die Wirksamkeit und Sicherheit der Produkte unerlässlich ist.\n\nObwohl USP \u003C1079> speziell auf die Pharmaindustrie zugeschnitten ist, können die in der Richtlinie dargelegten Grundsätze auch für andere Branchen, die empfindliche Produkte handhaben, von Nutzen sein.\n",[],{"__component":20,"id":148,"title":149,"content":150,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":151,"media":12,"employee":12},14206,"WHO – eine Welt voller Mapping-Richtlinien","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)",[152],{"id":153,"title":154,"href":155,"type":30,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13751,"Lesen Sie unseren WHO-Kartierungsleitfaden","\u002Ftemperature-mapping\u002Fwho-mapping-guidelines",{"__component":157,"id":158,"text":159,"columns":160,"title":12,"blockId":12,"hideOnMobile":12,"ulStyle":12,"ulColor":12,"buttons":161},"blocks.text",4102,"[![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":163,"id":164,"title":165,"content":166,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":47,"hideOnMobile":12,"questions":167},"blocks.faq",2208,"Weitere relevante Normen und Richtlinien","\n\n\n\n\n",[168,172,176,180,184,188,192,196,200,204,208],{"id":169,"question":170,"answer":171},14852,"WHO-Leitlinien für gute Lagerungspraktiken","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":173,"question":174,"answer":175},14853,"ICH Q10 (Pharmazeutisches Qualitätssystem)","Umfasst den gesamten pharmazeutischen Lebenszyklus und integriert Good Manufacturing Practices (GMPs) mit Qualitätssystemen und Risikomanagement.",{"id":177,"question":178,"answer":179},14854,"EU Anhang 11 (Europa)","Ähnlich wie [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11) konzentriert sich EU Annex 11 auf digitale Aufzeichnungen. Es regelt, wie Aufzeichnungen im Pharmasektor, einschließlich solcher im Zusammenhang mit der Temperaturkontrolle, verwaltet werden sollten, um ihre Integrität, Zuverlässigkeit und die Einhaltung der EU-Vorschriften zu gewährleisten.",{"id":181,"question":182,"answer":183},14855,"EU GMP Anhang 15","Dies befasst sich mit der Qualifizierung und Validierung von Prozessen und Systemen, die in der pharmazeutischen Herstellung eingesetzt werden; einschließlich der Sicherstellung, dass [Temperaturüberwachungssysteme](\u002Ftemperature-monitoring\u002Fsystems) qualifiziert und validiert sind. Der Schwerpunkt liegt auf den physikalischen Aspekten und der Leistung von Ausrüstungen und Prozessen, um sicherzustellen, dass sie für den vorgesehenen Verwendungszweck geeignet sind und definierten Spezifikationen entsprechen.",{"id":185,"question":186,"answer":187},14856,"EudraLex Band 4 (EU)","Dies enthält Richtlinien für die Herstellung, Einfuhr und den Vertrieb von Arzneimitteln in der EU.",{"id":189,"question":190,"answer":191},14857,"ASTM E2500","Ein von [ASTM International](https:\u002F\u002Fwww.astm.org\u002F) entwickelter Standard, der einen Leitfaden für die Spezifikation, Gestaltung und Verifizierung von pharmazeutischen und biopharmazeutischen Herstellungssystemen und -ausrüstungen bereitstellt und dabei unter anderem die Temperaturkontrolle abdeckt.",{"id":193,"question":194,"answer":195},14858,"EN 12830","Anforderungen an Temperaturaufzeichnungsgeräte, die beim Transport, der Lagerung und dem Vertrieb von temperaturempfindlichen Lebensmitteln eingesetzt werden.",{"id":197,"question":198,"answer":199},14859,"ASTM E2870","Bewertet die Wirksamkeit antimikrobieller Handwaschformulierungen, bei denen eine kontrollierte Temperatur während der Prüfung entscheidend ist.",{"id":201,"question":202,"answer":203},14860,"ASHRAE-Standards","Richtlinien für HLK-Systeme, die für die Aufrechterhaltung kontrollierter Temperaturen in Einrichtungen unerlässlich sind.",{"id":205,"question":206,"answer":207},14861,"AAMI ST79","Umfassender Leitfaden zur Dampfsterilisation in Gesundheitseinrichtungen, bei der die Temperaturkontrolle für die Sterilität entscheidend ist.",{"id":209,"question":210,"answer":211},14862,"CLSI M22-A3","Qualitätskontrolle für kommerziell hergestellte mikrobiologische Kulturmedien, mit Schwerpunkt auf Temperaturkontrolle während der Herstellung und Lagerung.",{"__component":45,"id":213,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},15362,{"__component":215,"id":216,"title":217,"content":218,"blockId":12,"imageUrl":12,"hideOnMobile":12,"buttons":219,"backgroundImage":12},"blocks.media-and-text-overlay",359,"Das war eine Menge…","**Glücklicherweise gelten nicht alle Vorschriften für Ihre Betriebsabläufe.**\n\n**Welche also? Unsere Compliance-Spezialisten stehen Ihnen gerne zur Verfügung (unverbindlich).**",[220],{"id":221,"title":222,"href":223,"type":224,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13752,"Buchen Sie eine kostenlose 15-minütige Beratung","\u002Fbook-demo","white",{"__component":226,"id":227,"title":228,"lead":229,"iconStyle":230,"withBackground":47,"blockId":231,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":232},"blocks.icon-grid",2726,"3 Schritte zur Implementierung von Compliance in Ihren Betriebsabläufen","Wir haben eine Vielzahl von Vorschriften und Compliance-Anforderungen für die Temperaturkontrolle von pharmazeutischen und anderen temperatursensiblen Produkten und Proben durchgearbeitet.\nWie halten Sie nun Prüfer zufrieden und integrieren die relevanten Regeln und Best Practices in Ihre Betriebsabläufe?\nEs gibt keine universelle Lösung, aber es gibt drei Hauptbereiche zu berücksichtigen: \n","Style 1","3stepsToImplementingComplianceInYourOperations",[233,240,247],{"id":234,"title":235,"lead":236,"icon":237,"linkTitle":238,"linkHref":239,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14147,"Verwendung eines (konformen) Temperaturüberwachungssystems","Die Implementierung eines zuverlässigen Temperaturüberwachungssystems und dessen konforme Nutzung sind für die Temperatur-Compliance unerlässlich. Die Systeme sollten Echtzeit-Überwachung, Datenprotokollierung und sofortige Alarmierung bieten, um die Integrität empfindlicher Produkte zu gewährleisten.","Monitoring","Worauf zu achten ist","\u002Ftemperature-monitoring\u002Fsystems",{"id":241,"title":242,"lead":243,"icon":244,"linkTitle":245,"linkHref":246,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14148,"Regelmäßige Temperaturkartierungen durchführen","Temperature-Mapping wird verwendet, um zu validieren, dass Lagerumgebungen die erforderlichen Temperaturvorgaben konsistent einhalten – und die Durchführung ist Teil der Vorschriften für die meisten Branchen, die mit temperaturempfindlichen Produkten arbeiten. Es umfasst eine detaillierte Analyse der Temperaturverteilung in einem Lagerbereich, um Gleichmäßigkeit sicherzustellen und potenzielle Problembereiche zu identifizieren.","Mapping","Wie man ein konformes Mapping durchführt","\u002Ftemperature-mapping",{"id":248,"title":249,"lead":250,"icon":251,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14149,"Verwendung von kalibriertem Equipment","Die Grundlage zuverlässiger Messung. Die regelmäßige Kalibrierung von Temperaturüberwachungsgeräten ist in den meisten Branchen für die Compliance erforderlich. Sie gewährleistet die Genauigkeit von Datenloggern und Sensoren sowie die Zuverlässigkeit der Daten.","Calibration",{"__component":74,"id":253,"title":254,"content":255,"video":12,"blockId":12,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":256,"media":12,"employee":12},3843,"Natürlich,","Diese Übersicht deckt nicht jeden Aspekt der Sicherstellung der Temperaturkonformität für Ihre Organisation ab. Diese drei Bereiche – Monitoring, Mapping und Kalibrierung – bilden jedoch die Säulen der Temperaturkonformität, und die Implementierung zuverlässiger Systeme und Prozesse für alle drei kann als Rahmen für die Entwicklung eines konformen Setups dienen.\n\n**Als Nächstes: Wie Technologie dies erheblich vereinfachen kann.**",[],{"__component":111,"id":258,"title":259,"lead":260,"hubspotFormId":261,"blockId":262,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":12},3365,"Automatisierte Temperatur-Compliance an einem Ort","Temperature-Compliance sollte nicht schwierig sein.\n\nBehalten Sie jederzeit die volle Kontrolle über Ihre Temperature-Compliance. Vereinen Sie [Monitoring](\u002Ftemperature-monitoring\u002Four-monitoring-solution\u002F), [Mapping](\u002Ftemperature-mapping\u002Four-mapping-solution\u002F) und [Kalibrierung](\u002Ftemperature-calibration\u002Four-calibration-solution\u002F) in einer GxP-konformen Lösung.","76bf4d75-d529-402d-85d6-200a1bf95457","catalogDownload",{"__component":226,"id":264,"title":265,"lead":266,"iconStyle":267,"withBackground":17,"blockId":268,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":269},2727,"Wie Technologie die Temperaturkonformität zum Selbstläufer macht","Die Navigation durch die Temperatur-Compliance bedeutet, sich durch eine umfassende Bandbreite an Vorschriften, Normen und Richtlinien zu bewegen, was verwirrend und überwältigend sein kann.\n\nGlücklicherweise sind in den letzten Jahren technische Fortschritte und [digitale Überwachungslösungen](\u002Ftemperature-monitoring\u002Fsystems) entstanden, die darauf ausgelegt sind, die Compliance für die Anwender zu einer unkomplizierten Angelegenheit zu machen.\n","Style 2","howTechnologyCanMakeTemperatureComplianceANonIssue",[270,275,280,285,290,295,299,304,309],{"id":271,"title":272,"lead":273,"icon":274,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14150,"Live- und automatisierte Temperaturüberwachung","um sofortige Maßnahmen bei Abweichungen zu ermöglichen.","Therometer",{"id":276,"title":277,"lead":278,"icon":279,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14151,"Erweiterte Alarme","mit anpassbaren Alarmen, der Filterung von Graubereichen und der Anpassung von Benachrichtigungen an spezifische Compliance-Anforderungen.","BellNotification",{"id":281,"title":282,"lead":283,"icon":284,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14152,"Automatisierte Abweichungsprotokollierung","die Registrierung, Analyse und Berichterstattung von Abweichungen effizienter zu gestalten.","GraphUp",{"id":286,"title":287,"lead":288,"icon":289,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14153,"Prüfungsfertige Berichte","mit nur wenigen Klicks generiert, um Audits zu vereinfachen.","Document1",{"id":291,"title":292,"lead":293,"icon":294,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14154,"Eine einzige Datenbank","mit \u003Cu>allen\u003C\u002Fu> Temperaturdaten an einem Ort, einschließlich Alarmen, Kalibrierzertifikaten und Mapping-Protokollen.","DeviceDesktop",{"id":296,"title":297,"lead":298,"icon":251,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14155,"Kalibrierungsmanagement","nicht nur die Verfolgung von Kalibrierzertifikaten, sondern auch von Zeitplänen.",{"id":300,"title":301,"lead":302,"icon":303,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14156,"Compliance-spezifische Funktionen","wie Module, die für [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11) konzipiert sind.","Award",{"id":305,"title":306,"lead":307,"icon":308,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14157,"Unterschiedliche Flexibilitätsstufen","bei Temperaturschwellenwerten, um Ihre regulatorischen Anforderungen zu erfüllen.","BarChartUp",{"id":310,"title":311,"lead":312,"icon":313,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},14158,"Und mehr","Einige Lösungen bieten auch Zugang zu Fachkundigen, die bei Compliance-Fragen Orientierung und Unterstützung bieten können.\n\nMit anderen Worten: Moderne Lösungen können zur Automatisierung und Optimierung eingesetzt werden – und Automatisierung bedeutet die Beseitigung manueller Fehler und Unstimmigkeiten in der Dokumentation, was die Compliance zuverlässiger macht.\n\n","CheckmarkRectangle",{"__component":111,"id":315,"title":316,"lead":317,"hubspotFormId":318,"blockId":319,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":12},3366,"Checkliste: 8 häufige Probleme bei der Temperatur-Compliance"," **(und ihre Lösungen)**\nTemperaturkonformität ist komplex, und daher passieren Fehler. Tauchen Sie ein in die häufigsten Probleme der Temperaturkonformität – und erfahren Sie, wie Sie diese vermeiden können.","d3f1159f-ee0c-4d7e-9230-c489c0ba5912","8frequentTemperatureComplianceIssues",{"__component":45,"id":321,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},15363,{"__component":20,"id":323,"title":324,"content":325,"blockId":326,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":327,"media":12,"employee":12},14200,"Häufig gestellte Fragen zur Temperaturkonformität","Wir haben bereits einige der häufigsten Fragen zu Vorschriften und Compliance für Temperaturüberwachung, thermische Kartierung und Kalibrierung behandelt. \n\n- [Was ist Temperatur-Compliance?](#whatIsTemperatureCompliance)\n- [Warum sind Vorschriften für die Temperatur-Compliance notwendig?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Vorschriften, Normen und Leitlinien – gibt es einen Unterschied?](#regulationsStandardsGuidelines)\n- [Wichtige Vorschriften und Normen der Temperatur-Compliance verstehen](#understandingKeyRegulationsAndStandards)\n- [3 Schritte zur Implementierung von Compliance in Ihren Betriebsabläufen](#3stepsToImplementingComplianceInYourOperations)\n- [Wie Technologie die Temperatur-Compliance zum Selbstläufer macht](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 häufige Probleme bei der Temperatur-Compliance (und ihre Lösungen)](#7frequentTemperatureComplianceIssues)\n- [Häufig gestellte Fragen zur Temperatur-Compliance](#faq)\n","faq",[],{"__component":163,"id":329,"title":12,"content":330,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":47,"hideOnMobile":12,"questions":331},2209,"### Außerdem\nhier sind einige weitere Fragen, die wir häufig zu Vorschriften und Richtlinien für die Temperaturkonformität erhalten:",[332,336,340,344,348,352],{"id":333,"question":334,"answer":335},14863,"Was ist Temperatur-Compliance und warum ist sie wichtig?","Temperatur-Compliance umfasst alle Qualitätsaufgaben, die darauf abzielen, sicherzustellen, dass temperatursensible Produkte, wie Arzneimittel, innerhalb bestimmter Temperaturbereiche gelagert, gehandhabt und transportiert werden. Dazu gehören [Temperaturüberwachung](\u002Ftemperature-monitoring), [thermisches Mapping](\u002Ftemperature-mapping) und [Kalibrierung](\u002Ftemperature-calibration). Dies ist in Branchen wie Pharma, Biotechnologie, Gesundheitswesen, pharmazeutischer Logistik und ähnlichen Bereichen von entscheidender Bedeutung, um die Produktintegrität, Wirksamkeit und Sicherheit zu gewährleisten, da viele Produkte durch Temperaturschwankungen beeinträchtigt werden können.",{"id":337,"question":338,"answer":339},14864,"Wie tragen Temperaturüberwachung, -kartierung und -kalibrierung zur Einhaltung von Vorschriften bei?","Die Temperaturüberwachung liefert Echtzeitdaten über die Umgebungsbedingungen und stellt sicher, dass Produkte sicher gelagert werden. Die Temperaturkartierung validiert, dass Lagerumgebungen die erforderlichen Spezifikationen konsistent erfüllen. Die Kalibrierung gewährleistet die Genauigkeit der bei der Überwachung und Kartierung eingesetzten Geräte und trägt so zur Zuverlässigkeit der Daten bei.",{"id":341,"question":342,"answer":343},14865,"Was sind die Unterschiede zwischen Vorschriften, Normen und Leitlinien bei der Temperatur-Compliance?","Vorschriften sind gesetzliche Anforderungen, die rechtlich durchsetzbar sind. Normen sind Maßstäbe, die durch Konsens unter Experten festgelegt werden und häufig freiwillig sind, sofern sie nicht in Vorschriften übernommen wurden. Leitlinien sind bewährte Verfahren oder Empfehlungen von maßgeblichen Institutionen.\n",{"id":345,"question":346,"answer":347},14866,"Was ist ISO 17025 und wie steht es im Zusammenhang mit der Temperaturkontrolle?","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) ist die internationale Norm für Kalibrierungs- und Prüflaboratorien, die deren Kompetenz und die Qualität ihrer Kalibrierungen bestätigt. Sie stellt sicher, dass Laboratorien strenge Standards für Genauigkeit und Zuverlässigkeit bei – unter anderem – Temperaturmessungen einhalten.",{"id":349,"question":350,"answer":351},14867,"Wie oft sollten Sie eine Temperaturkartierung durchführen, um die Vorschriften einzuhalten?","Die Häufigkeit Ihrer Temperaturkartierung hängt von verschiedenen Faktoren ab, angefangen bei der Art der gelagerten Produkte über die Stabilität der Umgebung bis hin zu den geltenden regulatorischen Anforderungen. \n\nDie Vorschriften variieren je nach Branche und Standort, aber als allgemeine Regel gilt, dass Sie sowohl Kartierungen neuer Geräte als auch regelmäßige Neukartierungen durchführen müssen. \n\n[Erfahren Sie mehr darüber, wie oft Sie eine Temperaturkartierung durchführen müssen](\u002Ftemperature-mapping)",{"id":353,"question":354,"answer":355},14868,"Wie kann Euprys Temperatur-Compliance-Lösung Ihnen helfen, regulatorische Standards zu erfüllen?","Wir freuen uns sehr, dass Sie gefragt haben. \n\n[Eupry's Temperatur-Compliance-Lösung](\u002Four-solution) basiert auf der Philosophie, dass Temperatur-Compliance nicht schwierig sein sollte. Sie integriert Monitoring, Mapping und Kalibrierung in einer einzigen digitalen Lösung. \n\n**Die Lösung:**\n- beseitigt redundante Aufgaben und Prozesse.\n- minimiert manuelle Arbeit und die damit verbundenen Fehler.\n- bietet Ihnen eine einzige Quelle der Wahrheit für alle Daten (von Temperaturaufzeichnungen bis hin zu Abweichungsberichten und Kalibrierzertifikaten).\n- ermöglicht Echtzeit-Monitoring\n- erlaubt Ihnen, prüffertige Berichte mit drei Klicks zu erstellen.\n\nUnd vieles mehr. \n\n[Fordern Sie einen Lösungskatalog an, um mehr zu erfahren](#catalogDownload)\n",{"__component":20,"id":357,"title":358,"content":359,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":360,"media":12,"employee":12},14201,"Was wir gelernt haben","Von FDA-Richtlinien bis hin zu ISO-Normen ist die Einhaltung der Anforderungen an die Temperaturkonformität unerlässlich – nicht nur um der Compliance willen, sondern um die Integrität der lebenswichtigen, temperatursensiblen Produkte und Proben in Branchen wie Gesundheitslogistik, Pharma und Biotechnologie zu gewährleisten.\n\nHierfür ist ein proaktiver Ansatz entscheidend. Wenn die Prüfer an Ihre Tür klopfen, wird es höchstwahrscheinlich zu spät sein.\n\nGlücklicherweise haben technologische Fortschritte den Prozess erheblich vereinfacht.\n\nModerne [Überwachungssysteme](\u002Ftemperature-monitoring\u002Fsystems) und Lösungen automatisieren und optimieren die Temperaturkontrolle und Qualitätssicherung, sodass die Einhaltung regulatorischer Anforderungen nicht nur zuverlässiger, sondern auch effizienter gestaltet wird. Einige Lösungen vereinen zudem bisher isolierte Prozesse (ja, das tun wir), wodurch das Risiko entfällt, dass wichtige Aufgaben zwischen den Stühlen fallen und daraus folgende Probleme entstehen.",[],{"__component":64,"id":362,"title":363,"lead":364,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":365,"card":370},798,"3 Orte, um tiefer einzutauchen","### 1. Sprechen Sie mit einem Experten (kostenlos)\nFühlen Sie sich von Vorschriften überwältigt? Keine Sorge, unser Team ist für Sie da. Buchen Sie eine kostenlose 15-minütige Beratung mit einem unserer Compliance-Spezialisten.\n",[366],{"id":367,"title":368,"href":369,"type":30,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},13753,"Jetzt ein Meeting buchen","\u002Fbook-price-talk",[371,377],{"id":372,"title":373,"lead":374,"linkTitle":375,"href":376,"blockId":12},472,"2. Mehr lesen","Erkunden Sie die Temperaturkonformität, indem Sie unsere Artikel lesen. Laden Sie unsere 9-Schritte-FDA-Compliance-Checkliste und unseren 6-Schritte-Leitfaden zur Reduzierung manueller Aufgaben herunter. Entdecken Sie außerdem, wie Sie die Temperaturüberwachung meistern können.","Unsere Artikel lesen","\u002Farticles",{"id":378,"title":379,"lead":380,"linkTitle":381,"href":382,"blockId":12},473,"3. Mehr ansehen","Sehen Sie sich unsere On-Demand-Videosessions an, die alles abdecken – von den Grundlagen des 21 CFR Part 11 für die Temperaturüberwachung bis hin zu aufschlussreichen Strategien zur vollständigen Automatisierung Ihrer Temperatur-Compliance-Prozesse.","Lernsitzungen ansehen","\u002Fwebinars",{},{"data":385,"meta":391},{"id":5,"documentId":10,"slug":7,"locale":11,"category":12,"localizations":386},[387],{"id":388,"documentId":10,"slug":389,"locale":390,"category":12},2206,"regulations-temperature-compliance","en",{},{"data":393,"meta":1127},{"id":388,"title":394,"slug":389,"createdAt":395,"updatedAt":396,"publishedAt":397,"documentId":10,"locale":390,"showOnArticlesPage":12,"disablePrerender":12,"category":12,"tagCategory":12,"blogImage":12,"settings":12,"seo":398,"body":402},"Pillar - Regulations temperature compliance","2024-01-09T14:54:37.338Z","2026-01-21T19:04:43.901Z","2026-01-21T19:24:33.655Z",{"id":399,"pageTitle":400,"shortDescription":401,"noIndex":17,"noAI":17,"noFollow":17,"Schema":12,"canonicalURL":12,"ogTitle":12,"ogDescription":12,"noSitemap":12,"image":12},2860,"Key regulations of temperature compliance","Master temperature compliance in pharmaceutical, biotech, and logistics. Discover key regulations, guidelines, and practical solutions.",[403,470,475,479,481,509,535,543,570,572,577,601,603,608,637,664,687,714,737,760,783,808,811,853,855,883,902,907,932,973,995,997,1041,1069,1108],{"__component":20,"id":404,"title":400,"content":405,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":23,"preTitleColor":12,"ctaInfoText":12,"titleLevel":24,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":406,"media":410,"employee":437},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",[407],{"id":408,"title":409,"href":29,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10069,"Automate temperature compliance with Eupry",{"id":411,"name":412,"alternativeText":413,"caption":12,"width":414,"height":415,"formats":416,"hash":428,"ext":418,"mime":421,"size":429,"url":430,"previewUrl":12,"provider":431,"provider_metadata":432,"createdAt":433,"updatedAt":434,"documentId":435,"publishedAt":436,"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":417},{"ext":418,"url":419,"hash":420,"mime":421,"name":422,"path":12,"size":423,"width":424,"height":425,"provider_metadata":426},".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":420,"resource_type":427},"image","Awards_Square_e5e9c029cb",120.96,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707046423\u002FAwards_Square_e5e9c029cb.jpg","cloudinary",{"public_id":428,"resource_type":427},"2024-02-04T11:33:44.112Z","2026-03-26T10:55:18.169Z","koyhvdupoezbt2oo9etd36p8","2025-01-29T12:38:47.261Z",{"id":438,"name":439,"workTitle":440,"testimonial":12,"email":12,"linkedIn":441,"createdAt":442,"updatedAt":443,"publishedAt":444,"documentId":445,"locale":390,"url":12,"image":446,"thumbnail":12,"localizations":469},197,"Jakob Konradsen","CQO  & co-founder","https:\u002F\u002Fwww.linkedin.com\u002Fin\u002Fjakob-konradsen-2ba0b694\u002F","2024-01-17T13:04:26.884Z","2025-05-22T14:39:06.541Z","2025-05-22T14:39:06.582Z","ba20sn47jua4m2o1etu4g24b",{"id":447,"name":448,"alternativeText":449,"caption":12,"width":450,"height":451,"formats":452,"hash":461,"ext":418,"mime":421,"size":462,"url":463,"previewUrl":12,"provider":431,"provider_metadata":464,"createdAt":465,"updatedAt":466,"documentId":467,"publishedAt":468,"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":453},{"ext":418,"url":454,"hash":455,"mime":421,"name":456,"path":12,"size":457,"width":458,"height":425,"sizeInBytes":459,"provider_metadata":460},"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":455,"resource_type":427},"Jakob_c5bef4b1d7",119.58,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1747924743\u002FJakob_c5bef4b1d7.jpg",{"public_id":461,"resource_type":427},"2025-05-22T14:39:03.832Z","2026-03-26T11:01:59.654Z","g5thni2w7vy0tqc3xlci6vc9","2025-05-22T14:39:03.833Z",[],{"__component":20,"id":471,"title":472,"content":473,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":474,"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":40,"id":476,"title":477,"content":478,"blockId":12,"imageUrl":12,"hideOnMobile":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":45,"id":480,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},8466,{"__component":20,"id":482,"title":483,"content":484,"blockId":52,"ulStyle":12,"video":12,"auto play":17,"imageLeftTextRight":17,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":485,"media":486,"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":487,"name":488,"alternativeText":489,"caption":12,"width":490,"height":491,"formats":492,"hash":501,"ext":418,"mime":421,"size":502,"url":503,"previewUrl":12,"provider":431,"provider_metadata":504,"createdAt":505,"updatedAt":506,"documentId":507,"publishedAt":508,"focalPoint":12},1024,"Question.jpg","3D isometric white question mark icon on a mint green gradient background",1200,889,{"thumbnail":493},{"ext":418,"url":494,"hash":495,"mime":421,"name":496,"path":12,"size":497,"width":498,"height":425,"sizeInBytes":499,"provider_metadata":500},"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":495,"resource_type":427},"Question_8740a74dd2",147.1,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1739784164\u002FQuestion_8740a74dd2.jpg",{"public_id":501,"resource_type":427},"2025-02-17T09:22:44.684Z","2026-03-26T10:59:57.656Z","gagqokbw0z2qrmyb8kkc8fks","2025-02-17T09:22:44.691Z",{"__component":20,"id":510,"title":511,"content":512,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":513,"media":517,"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.",[514],{"id":515,"title":516,"href":62,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10070,"How to unify temperature compliance",{"id":518,"name":519,"alternativeText":520,"caption":12,"width":414,"height":415,"formats":521,"hash":528,"ext":418,"mime":421,"size":529,"url":530,"previewUrl":12,"provider":431,"provider_metadata":531,"createdAt":532,"updatedAt":533,"documentId":534,"publishedAt":436,"focalPoint":12},590,"Graphs - Square.jpg","Isometric illustration of a desktop monitor displaying a line graph and pie chart with data analytics icons",{"thumbnail":522},{"ext":418,"url":523,"hash":524,"mime":421,"name":525,"path":12,"size":526,"width":424,"height":425,"provider_metadata":527},"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":524,"resource_type":427},"Graphs_Square_f6ad60c79e",222.52,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047079\u002FGraphs_Square_f6ad60c79e.jpg",{"public_id":528,"resource_type":427},"2024-02-04T11:44:40.175Z","2026-03-26T10:55:18.178Z","hyixp0bzf5k6aj3ejyiirrsu",{"__component":64,"id":536,"title":66,"lead":537,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":538,"card":542},693,"Eupry’s temperature compliance solution secures compliance and control of **_all_** your temperature-related quality efforts.",[539],{"id":540,"title":541,"href":29,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10071,"See how it works",[],{"__component":74,"id":544,"title":545,"content":546,"video":12,"blockId":78,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":547,"media":548,"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":549,"name":550,"alternativeText":551,"caption":12,"width":552,"height":553,"formats":554,"hash":563,"ext":418,"mime":421,"size":564,"url":565,"previewUrl":12,"provider":431,"provider_metadata":566,"createdAt":567,"updatedAt":568,"documentId":569,"publishedAt":436,"focalPoint":12},595,"pharmacist-work.jpg","Smiling pharmacist in white coat handing medication bag to customer at pharmacy counter",2000,941,{"thumbnail":555},{"ext":418,"url":556,"hash":557,"mime":421,"name":558,"path":12,"size":559,"width":560,"height":561,"provider_metadata":562},"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":557,"resource_type":427},"pharmacist_work_8e8e408998",282.21,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707050199\u002Fpharmacist_work_8e8e408998.jpg",{"public_id":563,"resource_type":427},"2024-02-04T12:36:39.701Z","2026-03-26T11:18:52.589Z","f5ufs4eph6m6xqidt79n6ytx",{"__component":45,"id":571,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},8467,{"__component":74,"id":573,"title":574,"content":575,"video":12,"blockId":86,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":576,"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":578,"title":12,"content":579,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":580,"media":581,"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":582,"name":583,"alternativeText":584,"caption":12,"width":414,"height":585,"formats":586,"hash":594,"ext":418,"mime":421,"size":595,"url":596,"previewUrl":12,"provider":431,"provider_metadata":597,"createdAt":598,"updatedAt":599,"documentId":600,"publishedAt":436,"focalPoint":12},591,"Pattern 05 - Square.jpg","Light green abstract arc and curve pattern shapes arranged decoratively on white background",898,{"thumbnail":587},{"ext":418,"url":588,"hash":589,"mime":421,"name":590,"path":12,"size":591,"width":592,"height":425,"provider_metadata":593},"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":589,"resource_type":427},"Pattern_05_Square_b24f628700",60.34,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047360\u002FPattern_05_Square_b24f628700.jpg",{"public_id":594,"resource_type":427},"2024-02-04T11:49:21.636Z","2026-03-26T10:55:18.174Z","unqyxochoh2h4i890cemkxh1",{"__component":45,"id":602,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},8468,{"__component":95,"id":604,"title":605,"lead":606,"blockId":99,"ulStyle":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"imageUrl":12,"subTitle":12,"hideOnMobile":12,"ulColor":12,"hideLastUpdated":12,"buttons":607,"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":609,"title":610,"content":611,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":612,"media":616,"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. ",[613],{"id":614,"title":615,"href":109,"type":30,"size":31,"arrow":32,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10072,"Learn more about FDA 21 CFR Part 11",{"id":617,"name":618,"alternativeText":619,"caption":12,"width":620,"height":621,"formats":622,"hash":630,"ext":418,"mime":421,"size":631,"url":632,"previewUrl":12,"provider":431,"provider_metadata":633,"createdAt":634,"updatedAt":635,"documentId":636,"publishedAt":436,"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":623},{"ext":418,"url":624,"hash":625,"mime":421,"name":626,"path":12,"size":627,"width":560,"height":628,"provider_metadata":629},"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":625,"resource_type":427},"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":630,"resource_type":427},"2024-02-01T22:52:58.389Z","2026-03-26T09:38:09.349Z","r10k7w0yic2xph1hdrbkauio",{"__component":111,"id":638,"title":639,"lead":640,"hubspotFormId":115,"blockId":116,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":641},2566,"FDA 21 CFR Part 11 compliance checklist","Simplify 21 CFR Part 11 compliance for your temperature monitoring with our 9-step checklist.",{"id":642,"name":643,"alternativeText":644,"caption":12,"width":645,"height":646,"formats":647,"hash":657,"ext":649,"mime":652,"size":658,"url":659,"previewUrl":12,"provider":431,"provider_metadata":660,"createdAt":661,"updatedAt":662,"documentId":663,"publishedAt":436,"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":648},{"ext":649,"url":650,"hash":651,"mime":652,"name":653,"path":12,"size":654,"width":655,"height":425,"provider_metadata":656},".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":651,"resource_type":427},"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":657,"resource_type":427},"2024-02-01T16:13:57.875Z","2026-03-26T09:45:01.359Z","ko5d4vmkokhdymap42vxpwjx",{"__component":20,"id":665,"title":666,"content":667,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":668,"media":669,"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":670,"name":671,"alternativeText":672,"caption":12,"width":414,"height":585,"formats":673,"hash":680,"ext":418,"mime":421,"size":681,"url":682,"previewUrl":12,"provider":431,"provider_metadata":683,"createdAt":684,"updatedAt":685,"documentId":686,"publishedAt":436,"focalPoint":12},593,"Pattern 07 - Square.jpg","Orange quarter-circle arc shapes arranged in a diagonal cascading pattern on white background",{"thumbnail":674},{"ext":418,"url":675,"hash":676,"mime":421,"name":677,"path":12,"size":678,"width":592,"height":425,"provider_metadata":679},"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":676,"resource_type":427},"Pattern_07_Square_2508e0e723",83.5,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047361\u002FPattern_07_Square_2508e0e723.jpg",{"public_id":680,"resource_type":427},"2024-02-04T11:49:22.035Z","2026-03-26T09:39:45.255Z","q77959mbmdn8ig0dthzv2iqu",{"__component":20,"id":688,"title":689,"content":690,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":691,"media":695,"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",[692],{"id":693,"title":694,"href":130,"type":30,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10073,"Learn more about ISO 17025-accredited calibration",{"id":696,"name":697,"alternativeText":698,"caption":12,"width":620,"height":621,"formats":699,"hash":707,"ext":418,"mime":421,"size":708,"url":709,"previewUrl":12,"provider":431,"provider_metadata":710,"createdAt":711,"updatedAt":712,"documentId":713,"publishedAt":436,"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":700},{"ext":418,"url":701,"hash":702,"mime":421,"name":703,"path":12,"size":704,"width":560,"height":628,"sizeInBytes":705,"provider_metadata":706},"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":702,"resource_type":427},"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":707,"resource_type":427},"2024-02-01T22:52:58.392Z","2026-03-26T11:16:21.879Z","dxxcwxpcrojlbr77q25fvayr",{"__component":20,"id":715,"title":716,"content":717,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":718,"media":719,"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":720,"name":721,"alternativeText":722,"caption":12,"width":620,"height":621,"formats":723,"hash":730,"ext":418,"mime":421,"size":731,"url":732,"previewUrl":12,"provider":431,"provider_metadata":733,"createdAt":734,"updatedAt":735,"documentId":736,"publishedAt":436,"focalPoint":12},539,"ISO compliance-regulation-logo.jpg","ISO 9001 certification logo with globe graphic and International Organization for Standardization text",{"thumbnail":724},{"ext":418,"url":725,"hash":726,"mime":421,"name":727,"path":12,"size":728,"width":560,"height":628,"provider_metadata":729},"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":726,"resource_type":427},"ISO_compliance_regulation_logo_4df7ce7843",48.68,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049641\u002FISO_compliance_regulation_logo_4df7ce7843.jpg",{"public_id":730,"resource_type":427},"2024-02-01T22:52:58.430Z","2026-03-26T09:40:12.711Z","kx3jvk98037mj7bfxs5u89uo",{"__component":20,"id":738,"title":739,"content":740,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":741,"media":742,"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":743,"name":744,"alternativeText":745,"caption":12,"width":414,"height":415,"formats":746,"hash":753,"ext":418,"mime":421,"size":754,"url":755,"previewUrl":12,"provider":431,"provider_metadata":756,"createdAt":757,"updatedAt":758,"documentId":759,"publishedAt":436,"focalPoint":12},594,"GxP - Square.jpg","3D isometric GxP text logo in dark navy and light blue on a pale blue background",{"thumbnail":747},{"ext":418,"url":748,"hash":749,"mime":421,"name":750,"path":12,"size":751,"width":424,"height":425,"provider_metadata":752},"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":749,"resource_type":427},"Gx_P_Square_18cb1e7c20",99.56,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707048441\u002FGx_P_Square_18cb1e7c20.jpg",{"public_id":753,"resource_type":427},"2024-02-04T12:07:22.131Z","2026-03-26T10:55:18.177Z","kic58bg4pv04a4ptmfzune6d",{"__component":20,"id":761,"title":762,"content":763,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":764,"media":765,"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":766,"name":767,"alternativeText":768,"caption":12,"width":620,"height":621,"formats":769,"hash":776,"ext":418,"mime":421,"size":777,"url":778,"previewUrl":12,"provider":431,"provider_metadata":779,"createdAt":780,"updatedAt":781,"documentId":782,"publishedAt":436,"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":770},{"ext":418,"url":771,"hash":772,"mime":421,"name":773,"path":12,"size":774,"width":560,"height":628,"provider_metadata":775},"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":772,"resource_type":427},"USP_compliance_regulation_logo_56443166f4",26.47,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049628\u002FUSP_compliance_regulation_logo_56443166f4.jpg",{"public_id":776,"resource_type":427},"2024-02-01T22:52:58.337Z","2026-03-26T09:37:38.312Z","lo6jywzmqzd91f8ivuitwfia",{"__component":20,"id":784,"title":785,"content":150,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":786,"media":790,"employee":12},9760,"WHO – a world of mapping guidelines",[787],{"id":788,"title":789,"href":155,"type":30,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10074,"Read our WHO mapping guide",{"id":791,"name":792,"alternativeText":793,"caption":12,"width":620,"height":621,"formats":794,"hash":801,"ext":418,"mime":421,"size":802,"url":803,"previewUrl":12,"provider":431,"provider_metadata":804,"createdAt":805,"updatedAt":806,"documentId":807,"publishedAt":436,"focalPoint":12},537,"WHO - compliance-regulation-logo.jpg","WHO logo featuring a Rod of Asclepius over a world map, surrounded by laurel branches",{"thumbnail":795},{"ext":418,"url":796,"hash":797,"mime":421,"name":798,"path":12,"size":799,"width":560,"height":628,"provider_metadata":800},"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":797,"resource_type":427},"WHO_compliance_regulation_logo_6ab3ababb6",91.35,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049604\u002FWHO_compliance_regulation_logo_6ab3ababb6.jpg",{"public_id":801,"resource_type":427},"2024-02-01T22:52:58.395Z","2026-03-26T09:40:49.421Z","sz9ajus2c16a6yidbpcsovbs",{"__component":157,"id":809,"text":159,"columns":160,"title":12,"blockId":12,"hideOnMobile":12,"ulStyle":12,"ulColor":12,"buttons":810},2690,[],{"__component":163,"id":812,"title":813,"content":166,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":47,"hideOnMobile":12,"questions":814},1646,"Other relevant standards and guidelines",[815,818,822,826,830,834,837,840,843,847,850],{"id":816,"question":817,"answer":171},10635,"WHO guidelines for good storage practices",{"id":819,"question":820,"answer":821},10636,"ICH Q10 (Pharmaceutical Quality System)","Encompasses the entire pharmaceutical lifecycle, integrating Good Manufacturing Practices (GMPs) with quality systems and risk management.",{"id":823,"question":824,"answer":825},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":827,"question":828,"answer":829},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":831,"question":832,"answer":833},10639,"EudraLex Volume 4 (EU)","This provides directives for the manufacturing, importation, and distribution of medicinal products in the EU.",{"id":835,"question":190,"answer":836},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":838,"question":194,"answer":839},10641,"Requirements for temperature recorders used in the transport, storage, and distribution of temperature-sensitive food products.",{"id":841,"question":198,"answer":842},10642,"Evaluates the effectiveness of antimicrobial handwashing formulations, where controlled temperature during testing is crucial.",{"id":844,"question":845,"answer":846},10643,"ASHRAE Standards","Guidelines for HVAC systems, essential in maintaining controlled temperatures in facilities.",{"id":848,"question":206,"answer":849},10644,"Comprehensive guide to steam sterilization in healthcare facilities, where temperature control is vital for sterility.",{"id":851,"question":210,"answer":852},10645,"Quality control for commercially prepared microbiological culture media, emphasizing temperature control during preparation and storage.",{"__component":45,"id":854,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},8469,{"__component":215,"id":856,"title":857,"content":858,"blockId":12,"imageUrl":12,"hideOnMobile":12,"buttons":859,"backgroundImage":863},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).**",[860],{"id":861,"title":862,"href":223,"type":224,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10075,"Book a 15 -minute free consultation",{"id":864,"name":865,"alternativeText":866,"caption":12,"width":552,"height":867,"formats":868,"hash":876,"ext":418,"mime":421,"size":877,"url":878,"previewUrl":12,"provider":431,"provider_metadata":879,"createdAt":880,"updatedAt":881,"documentId":882,"publishedAt":436,"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":869},{"ext":418,"url":870,"hash":871,"mime":421,"name":872,"path":12,"size":873,"width":560,"height":874,"provider_metadata":875},"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":871,"resource_type":427},"adam_Support_cba96f8819",227.72,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1706905955\u002Fadam_Support_cba96f8819.jpg",{"public_id":876,"resource_type":427},"2024-02-02T12:16:21.479Z","2026-03-26T10:51:05.176Z","ujd7jkw0503im54hffccs0r6",{"__component":226,"id":884,"title":885,"lead":886,"iconStyle":230,"withBackground":47,"blockId":231,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":887},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",[888,893,898],{"id":889,"title":890,"lead":891,"icon":237,"linkTitle":892,"linkHref":239,"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":894,"title":895,"lead":896,"icon":244,"linkTitle":897,"linkHref":246,"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":899,"title":900,"lead":901,"icon":251,"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":74,"id":903,"title":904,"content":905,"video":12,"blockId":12,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":906,"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":111,"id":908,"title":909,"lead":910,"hubspotFormId":261,"blockId":262,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":911},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.",{"id":912,"name":913,"alternativeText":914,"caption":12,"width":915,"height":916,"formats":917,"hash":925,"ext":649,"mime":652,"size":926,"url":927,"previewUrl":12,"provider":431,"provider_metadata":928,"createdAt":929,"updatedAt":930,"documentId":931,"publishedAt":436,"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":918},{"ext":649,"url":919,"hash":920,"mime":652,"name":921,"path":12,"size":922,"width":923,"height":425,"provider_metadata":924},"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":920,"resource_type":427},"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":925,"resource_type":427},"2024-05-27T07:56:04.227Z","2026-03-26T09:38:44.105Z","o2nt9afsaareuldkr1hubbey",{"__component":226,"id":933,"title":934,"lead":935,"iconStyle":267,"withBackground":17,"blockId":268,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":936},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",[937,941,945,949,953,957,961,965,969],{"id":938,"title":939,"lead":940,"icon":274,"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":942,"title":943,"lead":944,"icon":279,"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":946,"title":947,"lead":948,"icon":284,"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":950,"title":951,"lead":952,"icon":289,"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":954,"title":955,"lead":956,"icon":294,"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":958,"title":959,"lead":960,"icon":251,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9913,"Calibration management","not only tracking calibration certificates but also schedules.",{"id":962,"title":963,"lead":964,"icon":303,"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":966,"title":967,"lead":968,"icon":308,"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":970,"title":971,"lead":972,"icon":313,"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":111,"id":974,"title":975,"lead":976,"hubspotFormId":318,"blockId":319,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":977},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.",{"id":978,"name":979,"alternativeText":980,"caption":12,"width":645,"height":646,"formats":981,"hash":988,"ext":649,"mime":652,"size":989,"url":990,"previewUrl":12,"provider":431,"provider_metadata":991,"createdAt":992,"updatedAt":993,"documentId":994,"publishedAt":436,"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":982},{"ext":649,"url":983,"hash":984,"mime":652,"name":985,"path":12,"size":986,"width":655,"height":425,"provider_metadata":987},"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":984,"resource_type":427},"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":988,"resource_type":427},"2024-06-13T11:21:41.650Z","2026-03-26T09:43:30.677Z","yw8fx9bk1qk9k76e29qjkhen",{"__component":45,"id":996,"divider":47,"blockId":12,"hideOnMobile":12,"spacing":12},8470,{"__component":20,"id":998,"title":999,"content":1000,"blockId":326,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1001,"media":1002,"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":1003,"name":1004,"alternativeText":1005,"caption":12,"width":414,"height":1006,"formats":1007,"hash":1034,"ext":418,"mime":421,"size":1035,"url":1036,"previewUrl":12,"provider":1037,"provider_metadata":12,"createdAt":1038,"updatedAt":1039,"documentId":1040,"publishedAt":436,"focalPoint":12},508,"Magnifying - Square.jpg","Isometric illustration of a dark navy magnifying glass on a light mint green background",886,{"large":1008,"small":1015,"medium":1022,"thumbnail":1029},{"ext":418,"url":1009,"hash":1010,"mime":421,"name":1011,"path":12,"size":1012,"width":1013,"height":1014},"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":418,"url":1016,"hash":1017,"mime":421,"name":1018,"path":12,"size":1019,"width":1020,"height":1021},"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":418,"url":1023,"hash":1024,"mime":421,"name":1025,"path":12,"size":1026,"width":1027,"height":1028},"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":418,"url":1030,"hash":1031,"mime":421,"name":1032,"path":12,"size":1033,"width":498,"height":425},"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":163,"id":1042,"title":12,"content":1043,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":47,"hideOnMobile":12,"questions":1044},1647,"### Besides these\nhere are some other questions we often get about regulations and guidelines for temperature compliance:",[1045,1049,1053,1057,1061,1065],{"id":1046,"question":1047,"answer":1048},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":1050,"question":1051,"answer":1052},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":1054,"question":1055,"answer":1056},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":1058,"question":1059,"answer":1060},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":1062,"question":1063,"answer":1064},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":1066,"question":1067,"answer":1068},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":1070,"title":1071,"content":1072,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":37,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1073,"media":1074,"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":1075,"name":1076,"alternativeText":1077,"caption":12,"width":414,"height":415,"formats":1078,"hash":1102,"ext":418,"mime":421,"size":1103,"url":1104,"previewUrl":12,"provider":1037,"provider_metadata":12,"createdAt":1105,"updatedAt":1106,"documentId":1107,"publishedAt":436,"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":1079,"small":1085,"medium":1091,"thumbnail":1097},{"ext":418,"url":1080,"hash":1081,"mime":421,"name":1082,"path":12,"size":1083,"width":1013,"height":1084},"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":418,"url":1086,"hash":1087,"mime":421,"name":1088,"path":12,"size":1089,"width":1020,"height":1090},"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":418,"url":1092,"hash":1093,"mime":421,"name":1094,"path":12,"size":1095,"width":1027,"height":1096},"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":418,"url":1098,"hash":1099,"mime":421,"name":1100,"path":12,"size":1101,"width":424,"height":425},"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":64,"id":1109,"title":1110,"lead":1111,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":1112,"card":1116},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",[1113],{"id":1114,"title":1115,"href":369,"type":30,"size":31,"arrow":131,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10076,"Book a meeting now",[1117,1122],{"id":1118,"title":1119,"lead":1120,"linkTitle":1121,"href":376,"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":1123,"title":1124,"lead":1125,"linkTitle":1126,"href":382,"blockId":12},455,"3. 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