[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"$fQMC87ITf0w3_gHHNIGgp4qFOsfBYMzAbMu7AtomF1Tg":3,"localizations-u7ca1f2v3guei9dnsq7wcqra-it":409,"pages-en-fallback-u7ca1f2v3guei9dnsq7wcqra":419,"global-seo-setting":1151,"header-setting-it":1198,"footer-it":1255,"navigations-it":1374,"certificates":1626,"localizations-pages-u7ca1f2v3guei9dnsq7wcqra-it":1770},{"data":4,"meta":408},{"id":5,"title":6,"slug":7,"createdAt":8,"updatedAt":8,"publishedAt":9,"documentId":10,"locale":11,"showOnArticlesPage":12,"disablePrerender":12,"prerenderTranslation":13,"category":12,"tagCategory":12,"blogImage":12,"settings":12,"seo":14,"body":18},3536,"Pillar - Normative sulla conformità termica","normative-conformita-temperatura","2026-08-02T19:36:19.469Z","2026-08-02T19:36:19.668Z","u7ca1f2v3guei9dnsq7wcqra","it",null,false,{"id":15,"pageTitle":16,"shortDescription":17,"noIndex":13,"noAI":13,"noFollow":13,"Schema":12,"canonicalURL":12,"ogTitle":12,"ogDescription":12,"noSitemap":12,"schemaType":12,"image":12},4698,"Normative sulla temperatura dei farmaci | Eupry","Panoramica completa delle normative GxP, FDA, ISO e WHO per la conservazione dei farmaci: requisiti, differenze e soluzioni pratiche per la conformità.",[19,58,64,69,73,79,88,98,105,107,113,117,119,126,135,142,147,157,162,167,172,181,187,237,239,250,277,282,288,339,345,347,353,381,386],{"__component":20,"id":21,"title":22,"content":23,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":24,"preTitleColor":12,"ctaInfoText":12,"titleLevel":25,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":26,"media":12,"employee":34},"blocks.media-and-text-split-view",18169,"Normative chiave sulla conformità termica","Sta trascorrendo troppo tempo a orientarsi tra le normative, pur rimanendo preoccupato di non soddisfare _tutti_ i requisiti e di non seguire _tutti_ gli standard che dovrebbe?\n\nQuando si lavora in settori altamente regolamentati come quello farmaceutico, biotecnologico e della logistica sanitaria, destreggiarsi nel panorama della **conformità termica** può essere una sfida.\n\nPer fortuna, siamo qui per aiutarla.\n\nEsaminiamo insieme le aree di conformità con cui _dovrebbe_ avere familiarità quando si lavora con il controllo della temperatura – dal [monitoraggio](\u002Ftemperature-monitoring) alla [mappatura della temperatura](\u002Ftemperature-mapping) e alla [calibrazione](\u002Ftemperature-calibration) – per aiutarla a orientarsi con sicurezza."," ","h1",[27],{"id":28,"title":29,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17091,"Automatizzi la conformità termica con Eupry","\u002Four-solution","black","default","right",{"id":35,"name":36,"workTitle":37,"testimonial":12,"email":12,"linkedIn":38,"createdAt":39,"updatedAt":39,"publishedAt":40,"documentId":41,"locale":11,"url":42,"image":12,"thumbnail":12,"localizations":43},230,"Jakob Konradsen","CQO e co-fondatore","https:\u002F\u002Fwww.linkedin.com\u002Fin\u002Fjakob-konradsen-2ba0b694\u002F","2026-08-02T19:36:03.593Z","2026-08-02T19:36:03.667Z","ba20sn47jua4m2o1etu4g24b","\u002Fabout-us\u002Fjakob-konradsen\u002F",[44,51],{"id":45,"name":36,"workTitle":46,"testimonial":12,"email":12,"linkedIn":38,"createdAt":47,"updatedAt":48,"publishedAt":49,"documentId":41,"locale":50,"url":42},219,"CQO  & co-founder","2024-01-17T13:04:26.884Z","2026-06-17T10:11:37.023Z","2026-06-17T10:13:20.886Z","en",{"id":52,"name":36,"workTitle":53,"testimonial":12,"email":12,"linkedIn":38,"createdAt":54,"updatedAt":55,"publishedAt":56,"documentId":41,"locale":57,"url":42},218,"CQO & Mitgründer","2026-06-09T08:36:39.547Z","2026-06-17T10:13:21.061Z","2026-06-09T08:36:39.621Z","de",{"__component":20,"id":59,"title":60,"content":61,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":63,"media":12,"employee":12},18160,"In questa pagina può esplorare:","- [Che cos'è la conformità termica?](#whatIsTemperatureCompliance)\n- [Perché le normative sono necessarie per la conformità termica?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Normative, standard e linee guida – esiste una differenza?](#regulationsStandardsGuidelines)\n- [Le principali normative e standard della conformità termica](#understandingKeyRegulationsAndStandards)\n- [3 passi per implementare la conformità nelle proprie operazioni](#3stepsToImplementingComplianceInYourOperations)\n- [Come la tecnologia può rendere la conformità termica un problema risolto](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 problemi frequenti di conformità termica (e le relative soluzioni)](#8frequentTemperatureComplianceIssues)\n- [Domande frequenti sulla conformità termica](#faq)","h2",[],{"__component":65,"id":66,"title":67,"content":68,"blockId":12,"imageUrl":12,"hideOnMobile":12,"media":12},"blocks.media-and-text-overflow-media",794,"Non solo temperatura","Sebbene la temperatura sia il nostro figlio preferito (e di conseguenza il focus di questa pagina), molte delle normative e degli altri componenti di conformità sono ugualmente rilevanti per il monitoraggio, la mappatura e la calibrazione relativi a **umidità**, **CO2**, **pressione differenziale** e altri parametri ambientali.",{"__component":70,"id":71,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},"blocks.divider",22506,true,{"__component":20,"id":74,"title":75,"content":76,"blockId":77,"ulStyle":12,"video":12,"auto play":13,"imageLeftTextRight":13,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":78,"media":12,"employee":12},18161,"Che cos'è la conformità alla temperatura?","Nel mondo della farmaceutica, della distribuzione di farmaci e della biotecnologia, esistono molti diversi ambiti normativi e, anche se si lavora nel settore della qualità, è possibile che questa espressione non sia stata incontrata molto spesso.\n\n**Ciononostante, il concetto ha il potenziale per ottimizzare considerevolmente il modo in cui gestiamo le problematiche di conformità termica nell'ambito GxP.**\n\n**La versione sintetica:** La conformità termica consolida le attività di qualità volte a garantire che i prodotti e i campioni sensibili alla temperatura vengano gestiti entro specifici intervalli di temperatura durante la produzione, lo stoccaggio e il trasporto.\n\n**Comprende tre discipline principali:**\n- Monitoraggio della temperatura\n- Validazione e mappatura della temperatura\n- Calibrazione dei [data logger](\u002Fsolutions\u002Fwireless-data-loggers) o dei sensori","whatIsTemperatureCompliance",[],{"__component":20,"id":80,"title":81,"content":82,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":83,"media":12,"employee":12},18170,"Perché la conformità alla temperatura dovrebbe essere gestita in modo unitario","Nella maggior parte delle organizzazioni, gli ambiti della conformità termica vengono gestiti in modo più o meno indipendente, da dipartimenti diversi che operano autonomamente con propri budget, attività, obiettivi e priorità.\n\n**Tuttavia, questo approccio è sia inefficiente che rischioso.**\n\nQuesti processi disconnessi non solo lasciano spazio a sforzi inutili e duplicati, colli di bottiglia e tempi morti, ma creano anche le condizioni affinché alcune questioni vengano trascurate.\n\nIn altre parole, quando monitoraggio, calibrazione e mappatura della temperatura non sono unificati, si rischia sia di avere processi di lavoro inefficienti sia di rendere vulnerabile la propria posizione di conformità.\n\nAl contrario, unificarli consente di ottimizzare i processi, integrare i dati, migliorare l'efficienza e mitigare i rischi.",[84],{"id":85,"title":86,"href":87,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17092,"Come unificare la conformità termica","\u002Fregulations-temperature-compliance\u002Funify-temperature-compliance",{"__component":89,"id":90,"title":91,"lead":92,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":93,"card":97},"blocks.call-to-action",889,"Psst...","La soluzione di conformità termica di Eupry garantisce la conformità e il controllo di **_tutti_** i vostri sforzi di qualità legati alla temperatura.",[94],{"id":95,"title":96,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17093,"Scopri come funziona",[],{"__component":99,"id":100,"title":101,"content":102,"video":12,"blockId":103,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":104,"media":12,"employee":12},"blocks.media-and-text",4948,"Perché le normative sono necessarie per la conformità termica?","Probabilmente è ovvio, ma vale comunque la pena sottolinearlo: le normative sulla conformità termica non esistono per rendere il nostro lavoro più dispendioso in termini di tempo, complesso e frustrante (ma siamo onesti, spesso può sembrare così). Il loro unico scopo è garantire che i prodotti rimangano efficaci e sicuri.\n\nNella logistica sanitaria, nel settore farmaceutico, nella biotecnologia e in settori simili, un'ampia gamma di prodotti e campioni è altamente sensibile anche a piccole deviazioni di temperatura. Di conseguenza, un [monitoraggio della temperatura](\u002Ftemperature-monitoring) e una [mappatura della temperatura](\u002Ftemperature-mapping) meticolosi sono necessari per garantire la qualità. Normative, standard e linee guida sono in vigore per assicurare che questi processi vengano eseguiti correttamente, salvaguardando in ultima analisi l'integrità e la sicurezza di questi prodotti essenziali.","whyAreRegulationsNecessaryForTemperatureCompliance",[],{"__component":70,"id":106,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},22507,{"__component":99,"id":108,"title":109,"content":110,"video":12,"blockId":111,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":112,"media":12,"employee":12},4949,"Normative, standard e linee guida – esiste una differenza?","Nel contesto della qualità, **standard**, **linee guida** e **normative** svolgono ciascuno un ruolo specifico nel definire pratiche e procedure – e la conformità nei settori altamente regolamentati implica spesso il rispetto di una combinazione di tutti e tre gli elementi per garantire sicurezza ed efficacia.\n\nQuesta sezione esplora le diverse definizioni e i casi d'uso di questi principi:","regulationsStandardsGuidelines",[],{"__component":20,"id":114,"title":12,"content":115,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":116,"media":12,"employee":12},18162,"## Normative nella conformità termica:\n- **Definizione:** Le normative sono requisiti legali creati da organismi governativi o agenzie di regolamentazione. Sono obbligatorie e applicabili per legge.\n- **Caratteristiche:** Le normative sono spesso specifiche e forniscono istruzioni o criteri dettagliati che devono essere rispettati. Sono giuridicamente vincolanti e il mancato rispetto può comportare sanzioni legali, incluse multe o provvedimenti disciplinari.\n- **Esempi:** Nel contesto della mappatura e del monitoraggio della temperatura, le normative possono essere emanate da enti come la [FDA](https:\u002F\u002Fwww.fda.gov\u002F) (U.S. Food and Drug Administration), l'[EMA](https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fhomepage) (Agenzia Europea per i Medicinali) o altre autorità sanitarie nazionali competenti.\n\n## Standard nella conformità termica:\n- **Definizione:** Gli standard sono stabiliti per consenso tra esperti del settore e sono spesso sviluppati da organizzazioni di normazione, sia internazionali che nazionali, come l'Organizzazione Internazionale per la Normazione [ISO](https:\u002F\u002Fwww.iso.org\u002Fhome.html) o l'American National Standards Institute [ANSI](https:\u002F\u002Fansi.org\u002F).\n- **Caratteristiche:** Gli standard forniscono linee guida per le pratiche, garantendo qualità, sicurezza ed efficienza. Sono generalmente volontari, a meno che non vengano adottati da un organismo di regolamentazione all'interno di una normativa. La conformità agli standard è spesso necessaria per l'accettazione sul mercato, la certificazione e talvolta la conformità normativa.\n- **Esempi:** ISO 9001 per i sistemi di gestione della qualità o [ISO 17025](\u002Fregulations-temperature-compliance\u002FIso-17025) per la competenza dei laboratori di prova e calibrazione sono standard che, pur essendo volontari, sono ampiamente riconosciuti e rispettati nei settori farmaceutico, biotecnologico e della logistica sanitaria.\n\n## Linee guida nella conformità termica:\n- **Definizione:** Le linee guida sono insiemi di raccomandazioni o migliori pratiche proposte da organizzazioni, spesso basate sulla ricerca e sul consenso degli esperti. Non sono giuridicamente applicabili, ma sono destinate a guidare i professionisti del settore in aree specifiche del loro lavoro.\n- **Caratteristiche:** Le linee guida sono generalmente più flessibili delle normative o degli standard, offrendo raccomandazioni piuttosto che regole rigide. Sono progettate per aiutare le organizzazioni a ottenere risultati migliori, ma non hanno forza di legge.\n- **Esempi:** Le linee guida delle [Buone Pratiche di Fabbricazione (GMP)](\u002Fregulations-temperature-compliance\u002Fgmp) forniscono quadri di riferimento affinché i produttori garantiscano che i prodotti siano costantemente fabbricati e controllati secondo gli standard di qualità, e le linee guida delle [Buone Pratiche di Distribuzione (GDP)](\u002Fgdp) assicurano che la qualità e l'integrità dei prodotti siano mantenute durante lo stoccaggio e il trasporto. Si noti che, sebbene queste linee guida non siano di per sé leggi, sono spesso basate su normative.\n\n**In sintesi:**\nLe normative sono giuridicamente vincolanti e devono essere rispettate, gli standard sono parametri di riferimento volontari che possono diventare obbligatori quando adottati da un organismo di regolamentazione, e le linee guida sono di natura consultiva e forniscono le migliori pratiche per ottenere i risultati ottimali.",[],{"__component":70,"id":118,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},22508,{"__component":120,"id":121,"title":122,"lead":123,"blockId":124,"ulStyle":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"imageUrl":12,"subTitle":12,"hideOnMobile":12,"ulColor":12,"hideLastUpdated":12,"buttons":125,"image":12,"employee":12},"blocks.hero",1714,"Comprendere le principali normative e gli standard della conformità termica","Esaminiamo le normative, gli standard e le linee guida specifici rilevanti per le vostre procedure di [monitoraggio della temperatura](\u002Ftemperature-monitoring), [mappatura](\u002Ftemperature-mapping) e [calibrazione](\u002Ftemperature-calibration\u002Four-calibration-solution).\n\n**Disclaimer:** Quanto segue è una sintesi degli standard comunemente associati alle iniziative di conformità termica. Si prega di notare che gli standard specifici applicabili alle vostre operazioni varieranno in base al settore di appartenenza, alla natura dei prodotti, alla clientela e ad altre considerazioni pertinenti.","understandingKeyRegulationsAndStandards",[],{"__component":20,"id":127,"title":128,"content":129,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":130,"media":12,"employee":12},18171,"FDA 21 CFR Part 11 – il pilastro della conformità digitale","[21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11) è un **regolamento** che definisce i criteri in base ai quali le firme elettroniche e i registri elettronici – tra cui i registri digitali della temperatura – possono essere considerati affidabili e attendibili.\nFa parte del Codice dei Regolamenti Federali (CFR) stabilito dalla Food and Drug Administration (FDA) degli Stati Uniti.\n\n**A chi è rilevante?**\n\nIl regolamento 21 CFR Part 11 è rilevante per le aziende operanti in settori regolamentati, come quello farmaceutico e biotecnologico, che in qualsiasi modo operano negli Stati Uniti (partner, clienti, distribuzione – tutto è incluso) e utilizzano sistemi digitali di monitoraggio della temperatura – o semplicemente conservano una versione digitale dei registri di temperatura a fini di conformità. In sostanza, riguarda praticamente chiunque lavori con prodotti sensibili alla temperatura.\nPer saperne di più su FDA 21 CFR Part 11.",[131],{"id":132,"title":133,"href":134,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17094,"Per saperne di più su FDA 21 CFR Part 11","\u002Fregulations-temperature-compliance\u002F21-cfr-part-11",{"__component":136,"id":137,"title":138,"lead":139,"hubspotFormId":140,"blockId":141,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":12},"blocks.download-form",4084,"Lista di controllo per la conformità FDA 21 CFR Part 11","Semplifica la conformità al 21 CFR Part 11 per il monitoraggio della temperatura con la nostra checklist in 9 passi.","d7a411b9-1404-4772-b1f4-9a868061578a","fdaDownload",{"__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":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":146,"media":12,"employee":12},18163,"FDA 21 CFR Part 211 – requisiti per la produzione di prodotti farmaceutici","Il 21 CFR Part **211** della FDA (da non confondere con il Part 11, anche se comprendiamo come possa accadere) è intitolato \"Current Good Manufacturing Practice for Finished Pharmaceuticals\".\n\nQuesta **normativa** disciplina le Buone Pratiche di Fabbricazione correnti (cGMP) – i requisiti minimi – per i metodi, gli impianti e i controlli utilizzati nella produzione, lavorazione, confezionamento o conservazione di un prodotto farmaceutico, al fine di garantire che soddisfi gli standard di qualità e sia sicuro per l'uso.\n\n**A chi è rivolta?**\n\nQuesta normativa è rilevante per i produttori farmaceutici negli Stati Uniti. Garantisce che i prodotti farmaceutici siano prodotti in condizioni ambientali adeguate, incluso il controllo della temperatura, per assicurarne la sicurezza, la purezza e l'efficacia.\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":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":151,"media":12,"employee":12},18172,"ISO 17025 – il riferimento per i laboratori di calibrazione e prova","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) è lo standard internazionale per la competenza dei laboratori di [calibrazione](\u002Ftemperature-calibration\u002Four-calibration-solution). In altre parole, un'accreditamento ISO 17025 è un marchio di qualità che attesta che un laboratorio di calibrazione rispetta i più elevati standard internazionali di precisione.\n\nLo standard è sviluppato dall'Organizzazione Internazionale per la Normazione – [ISO](https:\u002F\u002Fwww.iso.org\u002Fabout-us.html) – un'organizzazione indipendente e non governativa con 169 enti nazionali di normazione come membri, ciascuno dei quali rappresenta ISO nel proprio paese. L'organizzazione sviluppa un'ampia gamma di standard proprietari, industriali e commerciali per garantire qualità, sicurezza ed efficienza in tutti i settori.\n\n**A chi è rivolta?**\n\nLo standard è rilevante per i laboratori che eseguono la calibrazione di strumenti di temperatura e umidità, al fine di garantire accuratezza e affidabilità nelle misurazioni.\n\nPer le aziende che non dispongono di calibrazione interna, un'accreditamento ISO 17025 può essere rilevante nella scelta di fornitori di calibrazione o di [data logger](\u002Fdata-logger) pre-calibrati per il monitoraggio o la mappatura della temperatura.\n\nLa necessità di una calibrazione accreditata ISO 17025 rispetto a, ad esempio, una calibrazione tracciabile dipende in larga misura dalle condizioni normative del settore, dalla criticità delle misurazioni accurate nelle operazioni e dai requisiti dei clienti.\n\nPer misurazioni non critiche, settori a basso rischio, controllo qualità interno e simili, la calibrazione tracciabile potrebbe essere sufficiente; tuttavia, per i settori soggetti a normative rigorose con prodotti sensibili, la calibrazione accreditata ISO 17025 è spesso richiesta.",[152],{"id":153,"title":154,"href":155,"type":31,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17095,"Scopri di più sulla calibrazione accreditata ISO 17025","\u002Fregulations-temperature-compliance\u002Fiso-17025","none",{"__component":20,"id":158,"title":159,"content":160,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":161,"media":12,"employee":12},18164,"ISO 9001 – il marchio di approvazione della gestione della qualità","ISO 9001 è uno standard riconosciuto a livello globale per i sistemi di gestione della qualità (QMS).\n\nDefinisce i criteri per un QMS al fine di garantire la qualità costante di prodotti e servizi, soddisfacendo sia i requisiti dei clienti che quelli normativi.\n\nLo standard si basa su una serie di principi di gestione della qualità, tra cui l'orientamento al cliente, il coinvolgimento della direzione aziendale, un approccio per processi e il miglioramento continuo.\n\nPer la conformità termica, il ruolo di ISO 9001 è garantire che i processi di controllo della temperatura siano gestiti in modo affidabile e migliorati continuamente, nel rispetto degli standard di settore. Che si tratti di garantire l'efficacia dei farmaci o l'affidabilità dei dispositivi medici, ISO 9001 pone le basi per il mantenimento di elevati standard qualitativi nelle operazioni sensibili alla temperatura.\n\n**A chi è rilevante?**\n\nLo standard ISO 9001 è deliberatamente concepito per essere sufficientemente generale da consentire a quasi tutte le organizzazioni di riconoscersi in esso e di utilizzarlo per migliorare la qualità. Crea un valore particolarmente elevato per le organizzazioni operanti in settori in cui la fornitura di qualità costante è fondamentale. Si applica, ad esempio, alle aziende farmaceutiche, alle imprese biotecnologiche, ai produttori di dispositivi medici e a qualsiasi azienda coinvolta nel ciclo di vita dei prodotti correlati alla salute.",[],{"__component":20,"id":163,"title":164,"content":165,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":166,"media":12,"employee":12},18165,"GxP – l'ombrello delle buone pratiche","GxP comprende una serie di linee guida di conformità quali le [Buone Pratiche di Fabbricazione (GMP)](\u002Fregulations-temperature-compliance\u002Fgmp\u002F), le Buone Pratiche di Laboratorio (GLP), le Buone Pratiche Cliniche (GCP) e le [Buone Pratiche di Distribuzione (GDP)](\u002Fgdp).\n\nQueste linee guida sono essenziali per garantire che i prodotti siano sicuri, rispondano all'uso previsto e rispettino i processi di qualità lungo tutto il loro ciclo di vita. Nel contesto farmaceutico, GxP costituisce la base per la regolamentazione dello sviluppo e della produzione dei farmaci.\n\n**Vedi anche**: [AI nel GxP: cosa funziona e cosa è rischioso](\u002Fai)\n\n**A chi è rilevante?**\n\nDifferenti varianti delle linee guida [GxP](\u002Fregulations-temperature-compliance\u002Fgxp\u002F) sono rilevanti per un'ampia gamma di organizzazioni nei settori in cui la qualità e la conformità termica sono fondamentali – aziende farmaceutiche, organizzazioni biotecnologiche, ricerca clinica, fornitori di servizi sanitari, laboratori, nonché logistica e distribuzione, in particolare nella gestione di prodotti farmaceutici.\n\n**Vedi anche**: [Come soddisfare i requisiti di temperatura GMP](\u002Fregulations-temperature-compliance\u002Fgmp\u002F)",[],{"__component":20,"id":168,"title":169,"content":170,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":171,"media":12,"employee":12},18166,"USP \u003C1079> – linee guida per lo stoccaggio e la distribuzione a temperatura controllata","USP \u003C1079> è una linea guida sviluppata dalla United States Pharmacopeia (USP) – un'organizzazione scientifica senza scopo di lucro che stabilisce standard pubblici riconosciuti a livello federale per medicinali, integratori e ingredienti alimentari.\n\nDelinea le migliori pratiche per lo stoccaggio e la distribuzione di prodotti farmaceutici in condizioni di temperatura controllata, mantenendo l'integrità del prodotto lungo tutta la catena di fornitura e concentrandosi sul monitoraggio, il controllo e la documentazione della temperatura.\n\n**A chi è rivolta?**\n\nUSP \u003C1079> è applicabile alle organizzazioni coinvolte nella catena di fornitura farmaceutica, inclusi produttori, distributori e strutture di stoccaggio. È particolarmente rilevante per i soggetti che gestiscono prodotti farmaceutici termosensibili, per i quali il mantenimento di condizioni ambientali specifiche è essenziale per l'efficacia e la sicurezza del prodotto.\n\nSebbene USP \u003C1079> sia specificamente concepita per il settore farmaceutico, i principi delineati nella linea guida possono essere informativi anche per altri settori che trattano prodotti sensibili.\n",[],{"__component":20,"id":173,"title":174,"content":175,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":176,"media":12,"employee":12},18173,"WHO – un panorama mondiale di linee guida per la mappatura","L'Organizzazione Mondiale della Sanità (OMS), garante internazionale della salute pubblica, fornisce linee guida per la salvaguardia delle forniture sanitarie a livello mondiale. Queste linee guida sono concepite per gestire il complesso processo di conservazione e trasporto di prodotti sanitari in climi diversi.\n\nLa scelta delle linee guida OMS più pertinenti dipende dalle specifiche esigenze organizzative e dalla natura dei prodotti trattati – ma [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\", e [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\" offrono indicazioni mirate per diversi scenari di mappatura della temperatura.\n\n**A chi è rivolta?**\n\nLe linee guida OMS contenute nel Supplement 7, Supplement 8 e Annex 8 sono rilevanti per qualsiasi settore che gestisce la conservazione, la movimentazione e la distribuzione di prodotti termosensibili, garantendo l'integrità e la sicurezza del prodotto – dalle aziende farmaceutiche alle organizzazioni di logistica sanitaria.\n\nLe linee guida sono, appunto, linee guida e non standard o normative formali. Tuttavia, sebbene non siano obbligatorie per legge, rappresentano le migliori pratiche e possono essere utilizzate come principio guida per garantire l'affidabilità degli [studi di mappatura della temperatura](\u002Ftemperature-mapping). Inoltre, poiché l'OMS è un'autorità rispettata a livello globale in materia di salute e le sue linee guida sono considerate ben fondate, esse vengono spesso utilizzate come base per le normative nazionali.\n\n[Leggi la nostra guida completa alle linee guida OMS per la mappatura della temperatura](\u002Ftemperature-mapping\u002Fwho-mapping-guidelines\u002F)",[177],{"id":178,"title":179,"href":180,"type":31,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17096,"Leggi la nostra guida alla mappatura OMS","\u002Ftemperature-mapping\u002Fwho-mapping-guidelines",{"__component":182,"id":183,"text":184,"columns":185,"title":12,"blockId":12,"hideOnMobile":12,"ulStyle":12,"ulColor":12,"buttons":186},"blocks.text",4634,"[![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":188,"id":189,"title":190,"content":191,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":72,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":192},"blocks.faq",2906,"Altri standard e linee guida pertinenti","\n\n\n\n\n",[193,197,201,205,209,213,217,221,225,229,233],{"id":194,"question":195,"answer":196},20051,"Linee guida OMS per le buone pratiche di stoccaggio","Il \"[TRS 1025 - Annex 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002Ftrs-1025-annex-7)\" è una linea guida mondiale che sottolinea le corrette condizioni di conservazione, inclusi i requisiti di temperatura, per i prodotti medicali.",{"id":198,"question":199,"answer":200},20052,"ICH Q10 (Sistema di qualità farmaceutica)","Comprende l'intero ciclo di vita farmaceutico, integrando le Buone Pratiche di Fabbricazione (GMP) con i sistemi di qualità e la gestione del rischio.",{"id":202,"question":203,"answer":204},20053,"EU Annex 11 (Europa)","Analogamente a [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11), EU Annex 11 si concentra sui documenti digitali. Definisce le modalità di gestione dei registri nel settore farmaceutico, inclusi quelli relativi al controllo della temperatura, al fine di garantirne l'integrità, l'affidabilità e la conformità alle normative europee.",{"id":206,"question":207,"answer":208},20054,"EU GMP Annex 15","Questo documento riguarda la qualifica e la validazione dei processi e dei sistemi utilizzati nella produzione farmaceutica, inclusa la verifica che i [sistemi di monitoraggio della temperatura](\u002Ftemperature-monitoring\u002Fsystems) siano qualificati e validati. L'attenzione è rivolta agli aspetti fisici e alle prestazioni delle apparecchiature e dei processi, al fine di garantire che siano idonei all'uso previsto e conformi alle specifiche definite.",{"id":210,"question":211,"answer":212},20055,"EudraLex Volume 4 (EU)","Fornisce direttive per la produzione, l'importazione e la distribuzione di medicinali nell'UE.",{"id":214,"question":215,"answer":216},20056,"ASTM E2500","Uno standard sviluppato da [ASTM International](https:\u002F\u002Fwww.astm.org\u002F), che fornisce una guida per la specifica, la progettazione e la verifica dei sistemi e delle apparecchiature di produzione farmaceutica e biofarmaceutica, coprendo, tra gli altri aspetti, il controllo della temperatura.",{"id":218,"question":219,"answer":220},20057,"EN 12830","Requisiti per i registratori di temperatura utilizzati nel trasporto, nello stoccaggio e nella distribuzione di prodotti alimentari sensibili alla temperatura.",{"id":222,"question":223,"answer":224},20058,"ASTM E2870","Valuta l'efficacia delle formulazioni antimicrobiche per il lavaggio delle mani, in cui il controllo della temperatura durante i test è fondamentale.",{"id":226,"question":227,"answer":228},20059,"Standard ASHRAE","Linee guida per i sistemi HVAC, essenziali per il mantenimento di temperature controllate negli impianti.",{"id":230,"question":231,"answer":232},20060,"AAMI ST79","Guida completa alla sterilizzazione a vapore nelle strutture sanitarie, in cui il controllo della temperatura è fondamentale per la sterilità.",{"id":234,"question":235,"answer":236},20061,"CLSI M22-A3","Controllo della qualità per terreni di coltura microbiologici preparati commercialmente, con particolare attenzione al controllo della temperatura durante la preparazione e la conservazione.",{"__component":70,"id":238,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},22509,{"__component":240,"id":241,"title":242,"content":243,"blockId":12,"imageUrl":12,"hideOnMobile":12,"buttons":244,"backgroundImage":12},"blocks.media-and-text-overlay",462,"Era davvero molto… ","**Fortunatamente, non tutte le normative si applicano alle vostre operazioni.**\n\n**Quindi quali si applicano? I nostri specialisti della conformità sono pronti ad aiutarvi (senza alcun impegno).**",[245],{"id":246,"title":247,"href":248,"type":249,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17097,"Prenota una consulenza gratuita di 15 minuti","\u002Fbook-demo","white",{"__component":251,"id":252,"title":253,"lead":254,"iconStyle":255,"withBackground":72,"blockId":256,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":257},"blocks.icon-grid",3879,"3 passi per implementare la conformità nelle vostre operazioni","Abbiamo esaminato una miriade di normative e requisiti di conformità per il controllo della temperatura di prodotti farmaceutici e altri prodotti e campioni termosensibili.\nOra, come si fa a soddisfare i revisori e a incorporare le regole pertinenti e le migliori pratiche nelle vostre operazioni?\nNon esiste una soluzione universale, ma vi sono tre aree principali da considerare: \n","Style 1","3stepsToImplementingComplianceInYourOperations",[258,265,272],{"id":259,"title":260,"lead":261,"icon":262,"linkTitle":263,"linkHref":264,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19666,"Utilizzo di un sistema di monitoraggio della temperatura (conforme)","Implementare un sistema di monitoraggio della temperatura affidabile e utilizzarlo in modo conforme è essenziale per la conformità termica. I sistemi devono fornire monitoraggio in tempo reale, registrazione dei dati e avvisi immediati per mantenere l'integrità dei prodotti sensibili.","Monitoring","Cosa cercare","\u002Ftemperature-monitoring\u002Fsystems",{"id":266,"title":267,"lead":268,"icon":269,"linkTitle":270,"linkHref":271,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19667,"Eseguire mappature della temperatura regolari","La mappatura della temperatura viene utilizzata per validare che gli ambienti di stoccaggio soddisfino costantemente le specifiche di temperatura richieste – e la loro esecuzione fa parte delle normative per la maggior parte dei settori che lavorano con prodotti termosensibili. Comporta un'analisi dettagliata della distribuzione della temperatura all'interno di un'area di stoccaggio, garantendo l'uniformità e identificando eventuali aree problematiche.","Mapping","Come eseguire una mappatura conforme","\u002Ftemperature-mapping",{"id":273,"title":274,"lead":275,"icon":276,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19668,"Utilizzo di apparecchiature calibrate","Il fondamento di una misurazione affidabile. La calibrazione regolare delle apparecchiature di monitoraggio della temperatura è necessaria per la conformità termica nella maggior parte dei settori. Garantisce l'accuratezza dei data logger e dei sensori, nonché l'affidabilità dei dati.","Calibration",{"__component":99,"id":278,"title":279,"content":280,"video":12,"blockId":12,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":281,"media":12,"employee":12},4950,"Naturalmente,","questa panoramica non include ogni aspetto del garantire la conformità termica per la vostra organizzazione. Tuttavia, queste tre aree – monitoraggio, mappatura e calibrazione – costituiscono i pilastri della conformità termica, e l'implementazione di sistemi e processi affidabili per tutte e tre può fungere da framework per lo sviluppo di una configurazione conforme.\n\n**Di seguito, come la tecnologia può contribuire a semplificare notevolmente tutto ciò.**",[],{"__component":136,"id":283,"title":284,"lead":285,"hubspotFormId":286,"blockId":287,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":12},4085,"Conformità termica automatizzata in un unico posto","La conformità termica non dovrebbe essere difficile.\n\nMantieni il pieno controllo della tua conformità termica in ogni momento. Raccogli [monitoraggio](\u002Ftemperature-monitoring\u002Four-monitoring-solution\u002F), [mappatura](\u002Ftemperature-mapping\u002Four-mapping-solution\u002F) e [calibrazione](\u002Ftemperature-calibration\u002Four-calibration-solution\u002F) in un'unica soluzione conforme alle GxP.","6279652a-7e41-4638-abad-f7c30831578","catalogDownload",{"__component":251,"id":289,"title":290,"lead":291,"iconStyle":292,"withBackground":13,"blockId":293,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":294},3880,"Come la tecnologia può rendere la conformità termica un problema irrilevante","Navigare nella conformità termica significa orientarsi in un'ampia gamma di normative, standard e linee guida, che possono risultare complessi e difficili da gestire.\n\nFortunatamente, negli ultimi anni sono emersi progressi tecnologici e [soluzioni di monitoraggio digitale](\u002Ftemperature-monitoring\u002Fsystems) progettati per rendere la conformità un aspetto non problematico per gli utenti.","Style 2","howTechnologyCanMakeTemperatureComplianceANonIssue",[295,300,305,310,315,320,324,329,334],{"id":296,"title":297,"lead":298,"icon":299,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19669,"Monitoraggio della temperatura in tempo reale e automatizzato","per consentire un'azione immediata in caso di deviazioni.","Therometer",{"id":301,"title":302,"lead":303,"icon":304,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19670,"Allarmi avanzati","fornendo avvisi personalizzabili, eliminando le zone grigie e adattando le notifiche in base alle specifiche esigenze di conformità.","BellNotification",{"id":306,"title":307,"lead":308,"icon":309,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19671,"Registrazione automatizzata delle deviazioni","rendendo più efficienti la registrazione, l'analisi e la reportistica delle escursioni.","GraphUp",{"id":311,"title":312,"lead":313,"icon":314,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19672,"Report pronti per l'audit","generati con pochi clic per semplificare le verifiche ispettive.","Document1",{"id":316,"title":317,"lead":318,"icon":319,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19673,"Un unico database","con \u003Cu>tutti\u003C\u002Fu> i dati di temperatura accessibili in un unico luogo, inclusi allarmi, certificati di calibrazione e protocolli di mappatura della temperatura.","DeviceDesktop",{"id":321,"title":322,"lead":323,"icon":276,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19674,"Gestione della calibrazione","non solo per il monitoraggio dei certificati di calibrazione, ma anche dei relativi programmi.",{"id":325,"title":326,"lead":327,"icon":328,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19675,"Funzionalità specifiche per la conformità","come i moduli progettati per [FDA 21 CFR Part 11](\u002Fregulations-temperature-compliance\u002F21-cfr-part-11).","Award",{"id":330,"title":331,"lead":332,"icon":333,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19676,"Livelli variabili di flessibilità","nelle soglie di temperatura per soddisfare i requisiti normativi.","BarChartUp",{"id":335,"title":336,"lead":337,"icon":338,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},19677,"E altro ancora","Alcune soluzioni includono anche l'accesso a un supporto specialistico in grado di fornire orientamento e assistenza in merito alle problematiche di conformità.\n\nIn altre parole, le soluzioni moderne possono essere utilizzate per automatizzare e semplificare i processi – e l'automazione significa eliminare errori manuali e incongruenze nella tenuta dei registri, rendendo la conformità più affidabile.\n\n","CheckmarkRectangle",{"__component":136,"id":340,"title":341,"lead":342,"hubspotFormId":343,"blockId":344,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":12},4086,"Checklist: 8 problematiche frequenti nella conformità termica","**(e le relative soluzioni)**\nLa conformità termica è un ambito complesso e, di conseguenza, gli errori possono verificarsi. Approfondite le problematiche più comuni nella conformità termica e scoprite come evitarle.","8945a10f-34f7-4540-a062-bfe3386eb491","8frequentTemperatureComplianceIssues",{"__component":70,"id":346,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},22510,{"__component":20,"id":348,"title":349,"content":350,"blockId":351,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":352,"media":12,"employee":12},18167,"Domande frequenti sulla conformità termica","Abbiamo già trattato alcune delle domande più comuni in materia di normative e conformità per il monitoraggio delle temperature, la mappatura della temperatura e la calibrazione.\n\n- [Che cos'è la conformità termica?](#whatIsTemperatureCompliance)\n- [Perché le normative sono necessarie per la conformità termica?](#whyAreRegulationsNecessaryForTemperatureCompliance)\n- [Normative, standard e linee guida – esiste una differenza?](#regulationsStandardsGuidelines)\n- [Comprendere le principali normative e gli standard della conformità termica](#understandingKeyRegulationsAndStandards)\n- [3 passi per implementare la conformità nelle proprie operazioni](#3stepsToImplementingComplianceInYourOperations)\n- [Come la tecnologia può rendere la conformità termica un aspetto non problematico](#howTechnologyCanMakeTemperatureComplianceANonIssue)\n- [8 problematiche frequenti nella conformità termica (e le relative soluzioni)](#7frequentTemperatureComplianceIssues)\n- [Domande frequenti sulla conformità termica](#faq)","faq",[],{"__component":188,"id":354,"title":12,"content":355,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":72,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":356},2907,"### Oltre a queste\necco alcune altre domande che riceviamo spesso riguardo alle normative e alle linee guida per la conformità termica:",[357,361,365,369,373,377],{"id":358,"question":359,"answer":360},20062,"Che cos'è la conformità termica e perché è importante?","La conformità termica comprende tutte le attività di qualità volte a garantire che i prodotti sensibili alla temperatura, come i farmaci, vengano conservati, gestiti e trasportati entro specifici intervalli di temperatura. Ciò include il [monitoraggio della temperatura](\u002Ftemperature-monitoring), la [mappatura della temperatura](\u002Ftemperature-mapping) e la [calibrazione](\u002Ftemperature-calibration), ed è fondamentale in settori come quello farmaceutico, biotecnologico, sanitario, della logistica farmaceutica e affini, per mantenere l'integrità, l'efficacia e la sicurezza dei prodotti, poiché molti di essi possono essere negativamente influenzati dalle variazioni di temperatura.",{"id":362,"question":363,"answer":364},20063,"In che modo il monitoraggio, la mappatura della temperatura e la calibrazione contribuiscono alla conformità termica?","Il monitoraggio della temperatura fornisce dati in tempo reale sulle condizioni ambientali, garantendo che i prodotti vengano conservati in modo sicuro. La mappatura della temperatura valida che gli ambienti di stoccaggio soddisfino costantemente le specifiche richieste. La calibrazione garantisce la precisione delle apparecchiature utilizzate nel monitoraggio e nella mappatura, contribuendo all'affidabilità dei dati.",{"id":366,"question":367,"answer":368},20064,"Quali sono le differenze tra normative, standard e linee guida nella conformità termica?","Le normative sono requisiti legali applicabili per legge. Gli standard sono parametri di riferimento stabiliti per consenso tra esperti, spesso volontari a meno che non vengano recepiti nelle normative. Le linee guida sono buone pratiche o raccomandazioni emanate da organismi autorevoli.\n",{"id":370,"question":371,"answer":372},20065,"Che cos'è la ISO 17025 e come si relaziona al controllo della temperatura?","[ISO 17025](\u002Fregulations-temperature-compliance\u002Fiso-17025) è lo standard internazionale per i laboratori di calibrazione e prova, che ne attesta la competenza e la qualità delle calibrazioni eseguite. Garantisce che i laboratori rispettino rigorosi standard di accuratezza e affidabilità nelle misurazioni della temperatura, tra le altre.",{"id":374,"question":375,"answer":376},20066,"Con quale frequenza è necessario eseguire la mappatura della temperatura per essere conformi alle normative?","La frequenza della mappatura della temperatura dipende da diversi fattori, dalla natura dei prodotti conservati alla stabilità dell'ambiente e, naturalmente, dai requisiti normativi.\n\nLe normative variano in base al settore e alla località, ma come regola generale è necessario eseguire mappature delle nuove apparecchiature nonché rimappature periodiche.\n\n[Scopri di più sulla frequenza con cui è necessario eseguire la mappatura della temperatura](\u002Ftemperature-mapping)",{"id":378,"question":379,"answer":380},20067,"In che modo la soluzione di conformità termica di Eupry può aiutarti a soddisfare gli standard normativi?","Siamo molto lieti che tu l'abbia chiesto.\n\n[La soluzione di conformità termica di Eupry](\u002Four-solution) è costruita sull'ideologia che la conformità termica non debba essere difficile. Integra monitoraggio, mappatura e calibrazione in un'unica soluzione digitale.\n\n**La soluzione:**\n- elimina attività e processi ridondanti.\n- riduce al minimo il lavoro manuale e gli errori derivanti da operazioni manuali.\n- fornisce un'unica fonte di verità per tutti i dati (dai registri delle temperature ai rapporti sulle deviazioni e ai certificati di calibrazione).\n- garantisce il monitoraggio in tempo reale\n- consente di generare report pronti per gli audit in tre clic.\n\nE molto altro ancora.\n\n[Scarica il catalogo della soluzione per saperne di più](#catalogDownload)",{"__component":20,"id":382,"title":383,"content":384,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":385,"media":12,"employee":12},18168,"Cosa abbiamo imparato","Dalle linee guida FDA agli standard ISO, la gestione dei requisiti di conformità termica è essenziale – non solo ai fini della conformità, ma per garantire l'integrità dei prodotti e dei campioni termosensibili di fondamentale importanza in settori come la logistica sanitaria, il farmaceutico e il biotecnologico.\n\nPer questo, un approccio proattivo è fondamentale. Quando i revisori busseranno alla tua porta, sarà molto probabilmente troppo tardi.\n\nPer fortuna, i progressi tecnologici hanno reso il processo molto più semplice.\n\nI moderni [sistemi di monitoraggio](\u002Ftemperature-monitoring\u002Fsystems) e le soluzioni disponibili automatizzano e ottimizzano il controllo della temperatura e le attività di qualità, rendendo il processo di conformità ai requisiti normativi non solo più affidabile, ma anche più efficiente. Alcune soluzioni unificano inoltre processi precedentemente isolati (sì, lo facciamo anche noi), eliminando il rischio che attività importanti vengano trascurate e che ne derivino problemi successivi.",[],{"__component":89,"id":387,"title":388,"lead":389,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":390,"card":395},890,"3 risorse per approfondire","### 1. Parla con un esperto (gratuitamente)\nSommerso dalle normative? Non si preoccupi, il nostro team è a disposizione. Prenoti una consulenza gratuita di 15 minuti con uno dei nostri specialisti in conformità.\n",[391],{"id":392,"title":393,"href":394,"type":31,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},17098,"Prenota una riunione ora","\u002Fbook-price-talk",[396,402],{"id":397,"title":398,"lead":399,"linkTitle":400,"href":401,"blockId":12},526,"2. Approfondisci","Esplori la conformità termica consultando i nostri articoli. Scarichi la nostra checklist FDA in 9 passi e la nostra guida in 6 passi per ridurre le attività manuali. Scopra inoltre come padroneggiare il monitoraggio della temperatura.","Leggi i nostri articoli","\u002Farticles",{"id":403,"title":404,"lead":405,"linkTitle":406,"href":407,"blockId":12},527,"3. Guarda altri contenuti","Scopri le nostre sessioni video on-demand che coprono tutto, dalla comprensione degli elementi essenziali del 21 CFR Part 11 per il monitoraggio della temperatura a strategie approfondite per automatizzare completamente i processi di conformità termica.","Guarda le sessioni di apprendimento","\u002Fwebinars",{},{"data":410,"meta":418},{"id":5,"documentId":10,"slug":7,"locale":11,"category":12,"localizations":411},[412,415],{"id":413,"documentId":10,"slug":414,"locale":57,"category":12},3299,"vorschriften-zur-temperaturkonformitaet",{"id":416,"documentId":10,"slug":417,"locale":50,"category":12},2206,"regulations-temperature-compliance",{},{"data":420,"meta":1150},{"id":416,"title":421,"slug":417,"createdAt":422,"updatedAt":423,"publishedAt":424,"documentId":10,"locale":50,"showOnArticlesPage":12,"disablePrerender":12,"prerenderTranslation":12,"category":12,"tagCategory":12,"blogImage":12,"settings":12,"seo":425,"body":429},"Pillar - Regulations temperature compliance","2024-01-09T14:54:37.338Z","2026-01-21T19:04:43.901Z","2026-01-21T19:24:33.655Z",{"id":426,"pageTitle":427,"shortDescription":428,"noIndex":13,"noAI":13,"noFollow":13,"Schema":12,"canonicalURL":12,"ogTitle":12,"ogDescription":12,"noSitemap":12,"schemaType":12,"image":12},2860,"Key regulations of temperature compliance","Master temperature compliance in pharmaceutical, biotech, and logistics. Discover key regulations, guidelines, and practical solutions.",[430,491,496,500,502,529,555,563,590,592,597,621,623,628,657,685,708,735,758,781,804,830,833,874,876,904,923,928,954,995,1018,1020,1064,1092,1131],{"__component":20,"id":431,"title":427,"content":432,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":24,"preTitleColor":12,"ctaInfoText":12,"titleLevel":25,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":433,"media":437,"employee":464},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",[434],{"id":435,"title":436,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10069,"Automate temperature compliance with Eupry",{"id":438,"name":439,"alternativeText":440,"caption":12,"width":441,"height":442,"formats":443,"hash":455,"ext":445,"mime":448,"size":456,"url":457,"previewUrl":12,"provider":458,"provider_metadata":459,"createdAt":460,"updatedAt":461,"documentId":462,"publishedAt":463,"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":444},{"ext":445,"url":446,"hash":447,"mime":448,"name":449,"path":12,"size":450,"width":451,"height":452,"provider_metadata":453},".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":447,"resource_type":454},"image","Awards_Square_e5e9c029cb",120.96,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707046423\u002FAwards_Square_e5e9c029cb.jpg","cloudinary",{"public_id":455,"resource_type":454},"2024-02-04T11:33:44.112Z","2026-03-26T10:55:18.169Z","koyhvdupoezbt2oo9etd36p8","2025-01-29T12:38:47.261Z",{"id":45,"name":36,"workTitle":46,"testimonial":12,"email":12,"linkedIn":38,"createdAt":47,"updatedAt":48,"publishedAt":49,"documentId":41,"locale":50,"url":42,"image":465,"thumbnail":12,"localizations":488},{"id":466,"name":467,"alternativeText":468,"caption":12,"width":469,"height":470,"formats":471,"hash":480,"ext":445,"mime":448,"size":481,"url":482,"previewUrl":12,"provider":458,"provider_metadata":483,"createdAt":484,"updatedAt":485,"documentId":486,"publishedAt":487,"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":472},{"ext":445,"url":473,"hash":474,"mime":448,"name":475,"path":12,"size":476,"width":477,"height":452,"sizeInBytes":478,"provider_metadata":479},"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":474,"resource_type":454},"Jakob_c5bef4b1d7",119.58,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1747924743\u002FJakob_c5bef4b1d7.jpg",{"public_id":480,"resource_type":454},"2025-05-22T14:39:03.832Z","2026-03-26T11:01:59.654Z","g5thni2w7vy0tqc3xlci6vc9","2025-05-22T14:39:03.833Z",[489,490],{"id":52,"name":36,"workTitle":53,"testimonial":12,"email":12,"linkedIn":38,"createdAt":54,"updatedAt":55,"publishedAt":56,"documentId":41,"locale":57,"url":42},{"id":35,"name":36,"workTitle":37,"testimonial":12,"email":12,"linkedIn":38,"createdAt":39,"updatedAt":39,"publishedAt":40,"documentId":41,"locale":11,"url":42},{"__component":20,"id":492,"title":493,"content":494,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":495,"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":65,"id":497,"title":498,"content":499,"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":70,"id":501,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},8466,{"__component":20,"id":503,"title":504,"content":505,"blockId":77,"ulStyle":12,"video":12,"auto play":13,"imageLeftTextRight":13,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":506,"media":507,"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":508,"name":509,"alternativeText":510,"caption":12,"width":511,"height":90,"formats":512,"hash":521,"ext":445,"mime":448,"size":522,"url":523,"previewUrl":12,"provider":458,"provider_metadata":524,"createdAt":525,"updatedAt":526,"documentId":527,"publishedAt":528,"focalPoint":12},1024,"Question.jpg","3D isometric white question mark icon on a mint green gradient background",1200,{"thumbnail":513},{"ext":445,"url":514,"hash":515,"mime":448,"name":516,"path":12,"size":517,"width":518,"height":452,"sizeInBytes":519,"provider_metadata":520},"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":515,"resource_type":454},"Question_8740a74dd2",147.1,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1739784164\u002FQuestion_8740a74dd2.jpg",{"public_id":521,"resource_type":454},"2025-02-17T09:22:44.684Z","2026-03-26T10:59:57.656Z","gagqokbw0z2qrmyb8kkc8fks","2025-02-17T09:22:44.691Z",{"__component":20,"id":530,"title":531,"content":532,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":533,"media":537,"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.",[534],{"id":535,"title":536,"href":87,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10070,"How to unify temperature compliance",{"id":538,"name":539,"alternativeText":540,"caption":12,"width":441,"height":442,"formats":541,"hash":548,"ext":445,"mime":448,"size":549,"url":550,"previewUrl":12,"provider":458,"provider_metadata":551,"createdAt":552,"updatedAt":553,"documentId":554,"publishedAt":463,"focalPoint":12},590,"Graphs - Square.jpg","Isometric illustration of a desktop monitor displaying a line graph and pie chart with data analytics icons",{"thumbnail":542},{"ext":445,"url":543,"hash":544,"mime":448,"name":545,"path":12,"size":546,"width":451,"height":452,"provider_metadata":547},"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":544,"resource_type":454},"Graphs_Square_f6ad60c79e",222.52,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047079\u002FGraphs_Square_f6ad60c79e.jpg",{"public_id":548,"resource_type":454},"2024-02-04T11:44:40.175Z","2026-03-26T10:55:18.178Z","hyixp0bzf5k6aj3ejyiirrsu",{"__component":89,"id":556,"title":91,"lead":557,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":558,"card":562},693,"Eupry’s temperature compliance solution secures compliance and control of **_all_** your temperature-related quality efforts.",[559],{"id":560,"title":561,"href":30,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10071,"See how it works",[],{"__component":99,"id":564,"title":565,"content":566,"video":12,"blockId":103,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":567,"media":568,"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":569,"name":570,"alternativeText":571,"caption":12,"width":572,"height":573,"formats":574,"hash":583,"ext":445,"mime":448,"size":584,"url":585,"previewUrl":12,"provider":458,"provider_metadata":586,"createdAt":587,"updatedAt":588,"documentId":589,"publishedAt":463,"focalPoint":12},595,"pharmacist-work.jpg","Smiling pharmacist in white coat handing medication bag to customer at pharmacy counter",2000,941,{"thumbnail":575},{"ext":445,"url":576,"hash":577,"mime":448,"name":578,"path":12,"size":579,"width":580,"height":581,"provider_metadata":582},"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":577,"resource_type":454},"pharmacist_work_8e8e408998",282.21,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707050199\u002Fpharmacist_work_8e8e408998.jpg",{"public_id":583,"resource_type":454},"2024-02-04T12:36:39.701Z","2026-03-26T11:18:52.589Z","f5ufs4eph6m6xqidt79n6ytx",{"__component":70,"id":591,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},8467,{"__component":99,"id":593,"title":594,"content":595,"video":12,"blockId":111,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":596,"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":598,"title":12,"content":599,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":600,"media":601,"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":602,"name":603,"alternativeText":604,"caption":12,"width":441,"height":605,"formats":606,"hash":614,"ext":445,"mime":448,"size":615,"url":616,"previewUrl":12,"provider":458,"provider_metadata":617,"createdAt":618,"updatedAt":619,"documentId":620,"publishedAt":463,"focalPoint":12},591,"Pattern 05 - Square.jpg","Light green abstract arc and curve pattern shapes arranged decoratively on white background",898,{"thumbnail":607},{"ext":445,"url":608,"hash":609,"mime":448,"name":610,"path":12,"size":611,"width":612,"height":452,"provider_metadata":613},"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":609,"resource_type":454},"Pattern_05_Square_b24f628700",60.34,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047360\u002FPattern_05_Square_b24f628700.jpg",{"public_id":614,"resource_type":454},"2024-02-04T11:49:21.636Z","2026-03-26T10:55:18.174Z","unqyxochoh2h4i890cemkxh1",{"__component":70,"id":622,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},8468,{"__component":120,"id":624,"title":625,"lead":626,"blockId":124,"ulStyle":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"imageUrl":12,"subTitle":12,"hideOnMobile":12,"ulColor":12,"hideLastUpdated":12,"buttons":627,"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":629,"title":630,"content":631,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":632,"media":636,"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. ",[633],{"id":634,"title":635,"href":134,"type":31,"size":32,"arrow":33,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10072,"Learn more about FDA 21 CFR Part 11",{"id":637,"name":638,"alternativeText":639,"caption":12,"width":640,"height":641,"formats":642,"hash":650,"ext":445,"mime":448,"size":651,"url":652,"previewUrl":12,"provider":458,"provider_metadata":653,"createdAt":654,"updatedAt":655,"documentId":656,"publishedAt":463,"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":643},{"ext":445,"url":644,"hash":645,"mime":448,"name":646,"path":12,"size":647,"width":580,"height":648,"provider_metadata":649},"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":645,"resource_type":454},"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":650,"resource_type":454},"2024-02-01T22:52:58.389Z","2026-03-26T09:38:09.349Z","r10k7w0yic2xph1hdrbkauio",{"__component":136,"id":658,"title":659,"lead":660,"hubspotFormId":661,"blockId":141,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":662},2566,"FDA 21 CFR Part 11 compliance checklist","Simplify 21 CFR Part 11 compliance for your temperature monitoring with our 9-step checklist.","4a62bd09-760d-4591-993e-fc0e2a0a8e01",{"id":663,"name":664,"alternativeText":665,"caption":12,"width":666,"height":667,"formats":668,"hash":678,"ext":670,"mime":673,"size":679,"url":680,"previewUrl":12,"provider":458,"provider_metadata":681,"createdAt":682,"updatedAt":683,"documentId":684,"publishedAt":463,"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":669},{"ext":670,"url":671,"hash":672,"mime":673,"name":674,"path":12,"size":675,"width":676,"height":452,"provider_metadata":677},".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":672,"resource_type":454},"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":678,"resource_type":454},"2024-02-01T16:13:57.875Z","2026-03-26T09:45:01.359Z","ko5d4vmkokhdymap42vxpwjx",{"__component":20,"id":686,"title":687,"content":688,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":689,"media":690,"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":691,"name":692,"alternativeText":693,"caption":12,"width":441,"height":605,"formats":694,"hash":701,"ext":445,"mime":448,"size":702,"url":703,"previewUrl":12,"provider":458,"provider_metadata":704,"createdAt":705,"updatedAt":706,"documentId":707,"publishedAt":463,"focalPoint":12},593,"Pattern 07 - Square.jpg","Orange quarter-circle arc shapes arranged in a diagonal cascading pattern on white background",{"thumbnail":695},{"ext":445,"url":696,"hash":697,"mime":448,"name":698,"path":12,"size":699,"width":612,"height":452,"provider_metadata":700},"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":697,"resource_type":454},"Pattern_07_Square_2508e0e723",83.5,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707047361\u002FPattern_07_Square_2508e0e723.jpg",{"public_id":701,"resource_type":454},"2024-02-04T11:49:22.035Z","2026-03-26T09:39:45.255Z","q77959mbmdn8ig0dthzv2iqu",{"__component":20,"id":709,"title":710,"content":711,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":712,"media":716,"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",[713],{"id":714,"title":715,"href":155,"type":31,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10073,"Learn more about ISO 17025-accredited calibration",{"id":717,"name":718,"alternativeText":719,"caption":12,"width":640,"height":641,"formats":720,"hash":728,"ext":445,"mime":448,"size":729,"url":730,"previewUrl":12,"provider":458,"provider_metadata":731,"createdAt":732,"updatedAt":733,"documentId":734,"publishedAt":463,"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":721},{"ext":445,"url":722,"hash":723,"mime":448,"name":724,"path":12,"size":725,"width":580,"height":648,"sizeInBytes":726,"provider_metadata":727},"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":723,"resource_type":454},"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":728,"resource_type":454},"2024-02-01T22:52:58.392Z","2026-03-26T11:16:21.879Z","dxxcwxpcrojlbr77q25fvayr",{"__component":20,"id":736,"title":737,"content":738,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":739,"media":740,"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":741,"name":742,"alternativeText":743,"caption":12,"width":640,"height":641,"formats":744,"hash":751,"ext":445,"mime":448,"size":752,"url":753,"previewUrl":12,"provider":458,"provider_metadata":754,"createdAt":755,"updatedAt":756,"documentId":757,"publishedAt":463,"focalPoint":12},539,"ISO compliance-regulation-logo.jpg","ISO 9001 certification logo with globe graphic and International Organization for Standardization text",{"thumbnail":745},{"ext":445,"url":746,"hash":747,"mime":448,"name":748,"path":12,"size":749,"width":580,"height":648,"provider_metadata":750},"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":747,"resource_type":454},"ISO_compliance_regulation_logo_4df7ce7843",48.68,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049641\u002FISO_compliance_regulation_logo_4df7ce7843.jpg",{"public_id":751,"resource_type":454},"2024-02-01T22:52:58.430Z","2026-03-26T09:40:12.711Z","kx3jvk98037mj7bfxs5u89uo",{"__component":20,"id":759,"title":760,"content":761,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":762,"media":763,"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":764,"name":765,"alternativeText":766,"caption":12,"width":441,"height":442,"formats":767,"hash":774,"ext":445,"mime":448,"size":775,"url":776,"previewUrl":12,"provider":458,"provider_metadata":777,"createdAt":778,"updatedAt":779,"documentId":780,"publishedAt":463,"focalPoint":12},594,"GxP - Square.jpg","3D isometric GxP text logo in dark navy and light blue on a pale blue background",{"thumbnail":768},{"ext":445,"url":769,"hash":770,"mime":448,"name":771,"path":12,"size":772,"width":451,"height":452,"provider_metadata":773},"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":770,"resource_type":454},"Gx_P_Square_18cb1e7c20",99.56,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707048441\u002FGx_P_Square_18cb1e7c20.jpg",{"public_id":774,"resource_type":454},"2024-02-04T12:07:22.131Z","2026-03-26T10:55:18.177Z","kic58bg4pv04a4ptmfzune6d",{"__component":20,"id":782,"title":783,"content":784,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":785,"media":786,"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":787,"name":788,"alternativeText":789,"caption":12,"width":640,"height":641,"formats":790,"hash":797,"ext":445,"mime":448,"size":798,"url":799,"previewUrl":12,"provider":458,"provider_metadata":800,"createdAt":801,"updatedAt":802,"documentId":803,"publishedAt":463,"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":791},{"ext":445,"url":792,"hash":793,"mime":448,"name":794,"path":12,"size":795,"width":580,"height":648,"provider_metadata":796},"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":793,"resource_type":454},"USP_compliance_regulation_logo_56443166f4",26.47,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049628\u002FUSP_compliance_regulation_logo_56443166f4.jpg",{"public_id":797,"resource_type":454},"2024-02-01T22:52:58.337Z","2026-03-26T09:37:38.312Z","lo6jywzmqzd91f8ivuitwfia",{"__component":20,"id":805,"title":806,"content":807,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":808,"media":812,"employee":12},9760,"WHO – a world of mapping guidelines","The World Health Organization (WHO), an international guardian of public health, provides guidelines for safeguarding health supplies worldwide. These guidelines are designed to manage the complex process of storing and transporting health products across diverse climates.\n\nSelecting the relevant WHO guidelines for you depends on your specific organizational needs and the nature of the products you handle – but [Supplement 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002FAnnex-9-f-trs-961): “Qualification of temperature-controlled storage areas”, [Supplement 8](https:\u002F\u002Fcdn.who.int\u002Fmedia\u002Fdocs\u002Fdefault-source\u002Fmedicines\u002Fnorms-and-standards\u002Fguidelines\u002Fdistribution\u002Ftrs961-annex9-supp8.pdf?sfvrsn=fb423ff8_2&download=true): “Temperature mapping of storage areas”, and [Annex 8](https:\u002F\u002Fwww.who.int\u002Fdocs\u002Fdefault-source\u002Fmedicines\u002Fnorms-and-standards\u002Fguidelines\u002Fproduction\u002Ftrs1010-annex8-who-gmp-heating-ventilation-airconditioning.pdf?sfvrsn=c77698e2_0): “Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products offer targeted advice for different scenarios in temperature mapping.\n\n**Who is it relevant for?**\n\nThe WHO guidelines in Supplement 7, Supplement 8, and Annex 8 are relevant for any sector managing the storage, handling, and distribution of temperature-sensitive products, ensuring product integrity and safety – from pharmaceutical companies to healthcare logistics organizations.\n\nThe guidelines are just that, guidelines, and not formal standards or regulations. But, although not legally required, they represent best practices and can be used as a guiding principle to secure the reliability of your [temperature mapping studies](\u002Ftemperature-mapping). Also, as the WHO is a respected authority on health globally and its guidelines are considered well-founded, the guidelines are often used as a basis for national regulations.\n\n[Read our full guide to the WHO's temperature mapping guides](\u002Ftemperature-mapping\u002Fwho-mapping-guidelines\u002F)",[809],{"id":810,"title":811,"href":180,"type":31,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10074,"Read our WHO mapping guide",{"id":813,"name":814,"alternativeText":815,"caption":12,"width":640,"height":641,"formats":816,"hash":823,"ext":445,"mime":448,"size":824,"url":825,"previewUrl":12,"provider":458,"provider_metadata":826,"createdAt":827,"updatedAt":828,"documentId":829,"publishedAt":463,"focalPoint":12},537,"WHO - compliance-regulation-logo.jpg","WHO logo featuring a Rod of Asclepius over a world map, surrounded by laurel branches",{"thumbnail":817},{"ext":445,"url":818,"hash":819,"mime":448,"name":820,"path":12,"size":821,"width":580,"height":648,"provider_metadata":822},"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":819,"resource_type":454},"WHO_compliance_regulation_logo_6ab3ababb6",91.35,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1707049604\u002FWHO_compliance_regulation_logo_6ab3ababb6.jpg",{"public_id":823,"resource_type":454},"2024-02-01T22:52:58.395Z","2026-03-26T09:40:49.421Z","sz9ajus2c16a6yidbpcsovbs",{"__component":182,"id":831,"text":184,"columns":185,"title":12,"blockId":12,"hideOnMobile":12,"ulStyle":12,"ulColor":12,"buttons":832},2690,[],{"__component":188,"id":834,"title":835,"content":191,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":72,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":836},1646,"Other relevant standards and guidelines",[837,841,845,849,852,855,858,861,864,868,871],{"id":838,"question":839,"answer":840},10635,"WHO guidelines for good storage practices","The “[TRS 1025 - Annex 7](https:\u002F\u002Fwww.who.int\u002Fpublications\u002Fm\u002Fitem\u002Ftrs-1025-annex-7)” is a worldwide guideline emphasizing the correct storage conditions, including temperature requirements, for medical products.",{"id":842,"question":843,"answer":844},10636,"ICH Q10 (Pharmaceutical Quality System)","Encompasses the entire pharmaceutical lifecycle, integrating Good Manufacturing Practices (GMPs) with quality systems and risk management.",{"id":846,"question":847,"answer":848},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":850,"question":207,"answer":851},10638,"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":853,"question":211,"answer":854},10639,"This provides directives for the manufacturing, importation, and distribution of medicinal products in the EU.",{"id":856,"question":215,"answer":857},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":859,"question":219,"answer":860},10641,"Requirements for temperature recorders used in the transport, storage, and distribution of temperature-sensitive food products.",{"id":862,"question":223,"answer":863},10642,"Evaluates the effectiveness of antimicrobial handwashing formulations, where controlled temperature during testing is crucial.",{"id":865,"question":866,"answer":867},10643,"ASHRAE Standards","Guidelines for HVAC systems, essential in maintaining controlled temperatures in facilities.",{"id":869,"question":231,"answer":870},10644,"Comprehensive guide to steam sterilization in healthcare facilities, where temperature control is vital for sterility.",{"id":872,"question":235,"answer":873},10645,"Quality control for commercially prepared microbiological culture media, emphasizing temperature control during preparation and storage.",{"__component":70,"id":875,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},8469,{"__component":240,"id":877,"title":878,"content":879,"blockId":12,"imageUrl":12,"hideOnMobile":12,"buttons":880,"backgroundImage":884},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).**",[881],{"id":882,"title":883,"href":248,"type":249,"size":32,"arrow":156,"blockId":12,"fullWidth":12,"quizId":12,"icon":12,"lucideIcon":12},10075,"Book a 15 -minute free consultation",{"id":885,"name":886,"alternativeText":887,"caption":12,"width":572,"height":888,"formats":889,"hash":897,"ext":445,"mime":448,"size":898,"url":899,"previewUrl":12,"provider":458,"provider_metadata":900,"createdAt":901,"updatedAt":902,"documentId":903,"publishedAt":463,"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":890},{"ext":445,"url":891,"hash":892,"mime":448,"name":893,"path":12,"size":894,"width":580,"height":895,"provider_metadata":896},"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":892,"resource_type":454},"adam_Support_cba96f8819",227.72,"https:\u002F\u002Fres.cloudinary.com\u002Feupry\u002Fimage\u002Fupload\u002Fv1706905955\u002Fadam_Support_cba96f8819.jpg",{"public_id":897,"resource_type":454},"2024-02-02T12:16:21.479Z","2026-03-26T10:51:05.176Z","ujd7jkw0503im54hffccs0r6",{"__component":251,"id":905,"title":906,"lead":907,"iconStyle":255,"withBackground":72,"blockId":256,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":908},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",[909,914,919],{"id":910,"title":911,"lead":912,"icon":262,"linkTitle":913,"linkHref":264,"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":915,"title":916,"lead":917,"icon":269,"linkTitle":918,"linkHref":271,"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":920,"title":921,"lead":922,"icon":276,"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":99,"id":924,"title":925,"content":926,"video":12,"blockId":12,"ulStyle":12,"preTitle":12,"preTitleColor":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"videoAutoplay":12,"hideOnMobile":12,"ctaInfoText":12,"hideLastUpdated":12,"buttons":927,"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":136,"id":929,"title":930,"lead":931,"hubspotFormId":932,"blockId":287,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":933},2567,"Automated temperature compliance in one place","Temperature compliance should not be hard.\n\nBe in full control of your temperature compliance at all times. Collect [monitoring](\u002Ftemperature-monitoring\u002Four-monitoring-solution\u002F), [mapping](\u002Ftemperature-mapping\u002Four-mapping-solution\u002F), and [calibration](\u002Ftemperature-calibration\u002Four-calibration-solution\u002F) in one GxP-compliant solution.","76bf4d75-d529-402d-85d6-200a1bf95457",{"id":934,"name":935,"alternativeText":936,"caption":12,"width":937,"height":938,"formats":939,"hash":947,"ext":670,"mime":673,"size":948,"url":949,"previewUrl":12,"provider":458,"provider_metadata":950,"createdAt":951,"updatedAt":952,"documentId":953,"publishedAt":463,"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":940},{"ext":670,"url":941,"hash":942,"mime":673,"name":943,"path":12,"size":944,"width":945,"height":452,"provider_metadata":946},"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":942,"resource_type":454},"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":947,"resource_type":454},"2024-05-27T07:56:04.227Z","2026-03-26T09:38:44.105Z","o2nt9afsaareuldkr1hubbey",{"__component":251,"id":955,"title":956,"lead":957,"iconStyle":292,"withBackground":13,"blockId":293,"ulStyle":12,"preTitle":12,"preTitleColor":12,"hideOnMobile":12,"layout":12,"iconItem":958},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",[959,963,967,971,975,979,983,987,991],{"id":960,"title":961,"lead":962,"icon":299,"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":964,"title":965,"lead":966,"icon":304,"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":968,"title":969,"lead":970,"icon":309,"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":972,"title":973,"lead":974,"icon":314,"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":976,"title":977,"lead":978,"icon":319,"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":980,"title":981,"lead":982,"icon":276,"linkTitle":12,"linkHref":12,"ulStyle":12,"backgroundColor":12,"lucideIcon":12,"showBackground":12},9913,"Calibration management","not only tracking calibration certificates but also schedules.",{"id":984,"title":985,"lead":986,"icon":328,"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":988,"title":989,"lead":990,"icon":333,"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":992,"title":993,"lead":994,"icon":338,"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":136,"id":996,"title":997,"lead":998,"hubspotFormId":999,"blockId":344,"hubspotMeetingUrl":12,"titleLevel":12,"preTitle":12,"preTitleColor":12,"imageUrl":12,"hideOnMobile":12,"media":1000},2568,"Checklist: 8 frequent temperature compliance issues"," **(and their solutions)**\nTemperature compliance is complex, and, as a result, mistakes happen. Dive into the most common issues of temperature compliance - and how you can avoid them.","d3f1159f-ee0c-4d7e-9230-c489c0ba5912",{"id":1001,"name":1002,"alternativeText":1003,"caption":12,"width":666,"height":667,"formats":1004,"hash":1011,"ext":670,"mime":673,"size":1012,"url":1013,"previewUrl":12,"provider":458,"provider_metadata":1014,"createdAt":1015,"updatedAt":1016,"documentId":1017,"publishedAt":463,"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":1005},{"ext":670,"url":1006,"hash":1007,"mime":673,"name":1008,"path":12,"size":1009,"width":676,"height":452,"provider_metadata":1010},"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":1007,"resource_type":454},"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":1011,"resource_type":454},"2024-06-13T11:21:41.650Z","2026-03-26T09:43:30.677Z","yw8fx9bk1qk9k76e29qjkhen",{"__component":70,"id":1019,"divider":72,"blockId":12,"hideOnMobile":12,"spacing":12},8470,{"__component":20,"id":1021,"title":1022,"content":1023,"blockId":351,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1024,"media":1025,"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":1026,"name":1027,"alternativeText":1028,"caption":12,"width":441,"height":1029,"formats":1030,"hash":1057,"ext":445,"mime":448,"size":1058,"url":1059,"previewUrl":12,"provider":1060,"provider_metadata":12,"createdAt":1061,"updatedAt":1062,"documentId":1063,"publishedAt":463,"focalPoint":12},508,"Magnifying - Square.jpg","Isometric illustration of a dark navy magnifying glass on a light mint green background",886,{"large":1031,"small":1038,"medium":1045,"thumbnail":1052},{"ext":445,"url":1032,"hash":1033,"mime":448,"name":1034,"path":12,"size":1035,"width":1036,"height":1037},"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":445,"url":1039,"hash":1040,"mime":448,"name":1041,"path":12,"size":1042,"width":1043,"height":1044},"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":445,"url":1046,"hash":1047,"mime":448,"name":1048,"path":12,"size":1049,"width":1050,"height":1051},"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":445,"url":1053,"hash":1054,"mime":448,"name":1055,"path":12,"size":1056,"width":518,"height":452},"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":188,"id":1065,"title":12,"content":1066,"blockId":12,"preTitle":12,"preTitleColor":12,"includeInGoogleSchema":72,"hideOnMobile":12,"subTitle":12,"fullWidth":12,"questions":1067},1647,"### Besides these\nhere are some other questions we often get about regulations and guidelines for temperature compliance:",[1068,1072,1076,1080,1084,1088],{"id":1069,"question":1070,"answer":1071},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":1073,"question":1074,"answer":1075},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":1077,"question":1078,"answer":1079},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":1081,"question":1082,"answer":1083},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":1085,"question":1086,"answer":1087},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":1089,"question":1090,"answer":1091},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":1093,"title":1094,"content":1095,"blockId":12,"ulStyle":12,"video":12,"auto play":12,"imageLeftTextRight":12,"preTitle":12,"preTitleColor":12,"ctaInfoText":12,"titleLevel":62,"imageUrl":12,"subTitle":12,"verticalCenteredText":12,"hideOnMobile":12,"hideTopDecoration":12,"hideLastUpdated":12,"buttons":1096,"media":1097,"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":1098,"name":1099,"alternativeText":1100,"caption":12,"width":441,"height":442,"formats":1101,"hash":1125,"ext":445,"mime":448,"size":1126,"url":1127,"previewUrl":12,"provider":1060,"provider_metadata":12,"createdAt":1128,"updatedAt":1129,"documentId":1130,"publishedAt":463,"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":1102,"small":1108,"medium":1114,"thumbnail":1120},{"ext":445,"url":1103,"hash":1104,"mime":448,"name":1105,"path":12,"size":1106,"width":1036,"height":1107},"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":445,"url":1109,"hash":1110,"mime":448,"name":1111,"path":12,"size":1112,"width":1043,"height":1113},"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":445,"url":1115,"hash":1116,"mime":448,"name":1117,"path":12,"size":1118,"width":1050,"height":1119},"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":445,"url":1121,"hash":1122,"mime":448,"name":1123,"path":12,"size":1124,"width":451,"height":452},"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":89,"id":1132,"title":1133,"lead":1134,"blockId":12,"titleLevel":12,"hideOnMobile":12,"buttons":1135,"card":1139},694,"3 places to dive deeper","### 1. 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