{"id":416,"date":"2023-10-10T11:42:45","date_gmt":"2023-10-10T09:42:45","guid":{"rendered":"https:\/\/dandiag.wpenginepowered.com\/?page_id=416"},"modified":"2026-04-18T12:13:34","modified_gmt":"2026-04-18T10:13:34","slug":"compliance","status":"publish","type":"page","link":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/","title":{"rendered":"Compliance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"416\" class=\"elementor elementor-416\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9d6f62f e-flex e-con-boxed e-con e-parent\" data-id=\"9d6f62f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bd80204 elementor-widget elementor-widget-heading\" data-id=\"bd80204\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Compliance i laboratorier - krav, dokumentation og drift<span style=\"font-size: 30px\"><\/span><br><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ddd37b7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"ddd37b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>I vores artikelarkiv kan du udforske n\u00f8gleaspekter inden for kvalitetssikring og overholdelse af regulativer inden for laboratorieudstyr og praksis. Opdag hvordan Cubis II MCA-software og Cubis\u00ae II balanceserie kan hj\u00e6lpe dig med at opn\u00e5 overholdelse og forbedre n\u00f8jagtighed og effektivitet i dit arbejde.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-72fcc52 e-flex e-con-boxed e-con e-parent\" data-id=\"72fcc52\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4c48cd2 elementor-widget elementor-widget-text-editor\" data-id=\"4c48cd2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Find mere om:<\/strong><\/p>\n<p><!-- \/wp:paragraph --><!-- wp:list --><\/p>\n<ul><!-- wp:list-item -->\n<li>21 CFR Part 11 overholdelse<\/li>\n<li>Tilpasningsdygtig konfigurering med Cubis\u00ae II<\/li>\n<li>Kvalitetssikring og standarder i medicinsk enhedsudvikling<\/li>\n<li>Elektronisk signatur og audit trail<\/li>\n<li>Dokumentation og validering<\/li>\n<li>Compliance-relaterede ressourcer og vejledninger<\/li>\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-de9ecc0 e-con-full e-flex e-con e-child\" data-id=\"de9ecc0\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-c5dada2 e-con-full e-flex e-con e-child\" data-id=\"c5dada2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-74dd6ef elementor-widget elementor-widget-text-editor\" data-id=\"74dd6ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Cubis\u00ae II MCA 21 CFR Part 11 Compliance Checklist<\/strong><\/p>\n<p>Is the system a Closed System, where system access is controlled by the persons who are responsible for the content of the electronic records that are on the system?<\/p>\n<p>Is the system an Open System, where system access is not controlled by the persons who are responsible for the content of the electronic records that are on the system? (e.g.<br \/>a service provider controls and maintains access of the contents of the system, etc.).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a51189e e-con-full e-flex e-con e-child\" data-id=\"a51189e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-923763c elementor-widget elementor-widget-button\" data-id=\"923763c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dandiag.dk\/wp-content\/uploads\/2023\/10\/checklist_Cubisii_21_CRF_compliance.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download PDF<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-b64cb0b e-con-full e-flex e-con e-child\" data-id=\"b64cb0b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-63d9e47 e-con-full e-flex e-con e-child\" data-id=\"63d9e47\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3a1ae11 elementor-widget elementor-widget-text-editor\" data-id=\"3a1ae11\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Protecting Data Integrity \u2014 Evaluating Instruments in the Lab<\/strong><\/p>\n<p>Compliance with data integrity regulations begins with all data-generating instruments and extends throughout lab systems\u2014evaluate your instruments and procedures with this checklist.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-92dd637 e-con-full e-flex e-con e-child\" data-id=\"92dd637\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d2f6aef elementor-widget elementor-widget-button\" data-id=\"d2f6aef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dandiag.dk\/wp-content\/uploads\/2023\/10\/Checklist_Protecting_Data_Integrity.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download PDF<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bf26ecf e-con-full e-flex e-con e-child\" data-id=\"bf26ecf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7e07dcd e-con-full e-flex e-con e-child\" data-id=\"7e07dcd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-024dab8 elementor-widget elementor-widget-text-editor\" data-id=\"024dab8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Cubis\u00ae II Pharma Compliant by Design<\/strong><\/p>\n<p>The Cubis\u00ae II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Choose from among 45 weighing modules, seven draft shields, two display and control units, and five software packages, including more than 60 software Apps.<br \/>Meet the requirements of the pharmaceutical industry with a combination of the MCA high-end 7\u201d display and specific QApp pharma package, providing all features needed for a full pharma-compliant lab balance system.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-676ca03 e-con-full e-flex e-con e-child\" data-id=\"676ca03\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-527ebe0 elementor-widget elementor-widget-button\" data-id=\"527ebe0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dandiag.dk\/wp-content\/uploads\/2023\/10\/Cubisii_21_CFR_Part_11_Compliance.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download PDF<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f05e47e e-con-full e-flex e-con e-child\" data-id=\"f05e47e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-87247e2 e-con-full e-flex e-con e-child\" data-id=\"87247e2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8d8981f elementor-widget elementor-widget-text-editor\" data-id=\"8d8981f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>On the Chapter 2.1.7 \u201cBalances for analytical purposes\u201d of the European Pharmacopoeia (Ph.Eur.)<\/strong><\/p>\n<p>The new chapter was published in July, 2021 and becomes effective on the 1st of January, 2022. The new chapter is mandatory for any analytical weighing procedure described in a Ph.Eur. monograph.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d3b7ba2 e-con-full e-flex e-con e-child\" data-id=\"d3b7ba2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-494d5c0 elementor-widget elementor-widget-button\" data-id=\"494d5c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dandiag.dk\/wp-content\/uploads\/2023\/10\/FAQ_Chapter_2.1.7_ph_Eur.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download PDF<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f51f030 e-con-full e-flex e-con e-child\" data-id=\"f51f030\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-f1ce492 e-con-full e-flex e-con e-child\" data-id=\"f1ce492\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cc715e2 elementor-widget elementor-widget-text-editor\" data-id=\"cc715e2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Are You Compliant When it Comes to Pipetting<\/strong>?<\/p>\n<p>When developing or testing your medical device, there is always the question: are you following methods for current Good Laboratory Practice (cGLP) or current Good Manufacturing Practice (cGMP)? In this practical guide, we\u2019ve compiled a list that you can follow to give you peace-of-mind on the topic of compliance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2043b48 e-con-full e-flex e-con e-child\" data-id=\"2043b48\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ae05a3c elementor-widget elementor-widget-button\" data-id=\"ae05a3c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dandiag.dk\/wp-content\/uploads\/2023\/10\/liquid_handling_glp_compliance.pdf\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Download PDF<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-40ba7e1 e-flex e-con-boxed e-con e-parent\" data-id=\"40ba7e1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d3e1fc3 elementor-widget elementor-widget-heading\" data-id=\"d3e1fc3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Compliance i praksis  krav. dokumentatiom, tr\u00e6ning og styring<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-db97f22 e-flex e-con-boxed e-con e-parent\" data-id=\"db97f22\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d717d59 elementor-widget elementor-widget-text-editor\" data-id=\"d717d59\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Compliance i laboratorier er ikke blot et sp\u00f8rgsm\u00e5l om at best\u00e5 en audit. Det er en struktureret tilgang til kvalitet, dokumentation og drift, der sikrer, at laboratoriets processer lever op til g\u00e6ldende lovgivning, standarder og interne procedurer. Uanset om der arbejdes under GMP, GLP, ISO 17025 eller ISO 15189, er regulatorisk compliance en foruds\u00e6tning for trov\u00e6rdige resultater og driftssikkerhed.<\/p>\n<p>I denne artikel gennemg\u00e5r vi, hvad compliance betyder i praksis, hvilke krav der g\u00e6lder for laboratorier, og hvordan dokumentation, tr\u00e6ning og leverand\u00f8rstyring spiller en central rolle.<\/p>\n<p>Hvad betyder compliance i praksis for laboratorier?<\/p>\n<p>Compliance i laboratorier handler om systematisk overholdelse af regulatoriske krav, standarder og interne kvalitetsprocedurer. Det omfatter blandt andet:<\/p>\n<ul>\n<li>Korrekt dokumentation i laboratoriet<\/li>\n<li>Sporbarhed p\u00e5 pr\u00f8ver, udstyr og forbrugsvarer<\/li>\n<li>Validerede metoder og kvalificeret udstyr<\/li>\n<li>Kontrolleret \u00e6ndringsstyring (change control)<\/li>\n<li>Afvigelsesh\u00e5ndtering og CAPA<\/li>\n<\/ul>\n<p>I praksis betyder det, at alle kritiske aktiviteter skal v\u00e6re dokumenterede, reproducerbare og sporbare. Compliance er t\u00e6t forbundet med kvalitetsstyring i laboratorier og sikrer, at data er valide og inspektionsklare.<\/p>\n<h2>Typiske compliance-fejl \u2013 og hvordan de undg\u00e5s<\/h2>\n<p>Compliance-fejl i laboratorier opst\u00e5r ofte ikke p\u00e5 grund af manglende vilje, men p\u00e5 grund af utilstr\u00e6kkelige systemer eller mangelfuld tr\u00e6ning.<\/p>\n<p>Typiske fejl omfatter:<\/p>\n<ul>\n<li>Manglende eller ufuldst\u00e6ndig dokumentation<\/li>\n<li>Uautoriserede \u00e6ndringer i SOP\u2019er<\/li>\n<li>Utilstr\u00e6kkelig kalibrering og vedligeholdelse af udstyr<\/li>\n<li>Manglende sporbarhed p\u00e5 forbrugsvarer<\/li>\n<li>Utilstr\u00e6kkelig audit-forberedelse<\/li>\n<\/ul>\n<p>Forebyggelse kr\u00e6ver klare procedurer, digital eller struktureret papirbaseret dokumentstyring samt l\u00f8bende intern kontrol. Et robust compliance management system reducerer risikoen for afvigelser og observationer ved ekstern audit.<\/p>\n<h2>Sammenh\u00e6ngen mellem compliance og driftssikkerhed<\/h2>\n<p>Compliance og driftssikkerhed h\u00e6nger t\u00e6t sammen. N\u00e5r laboratoriets processer er standardiserede og dokumenterede, reduceres risikoen for fejl, gentagelser og nedetid.<\/p>\n<p>Kalibreringsprogrammer, planlagt vedligeholdelse og validering af laboratorieudstyr sikrer stabil drift. Samtidig betyder korrekt h\u00e5ndtering af afvigelser, at problemer identificeres og korrigeres systematisk.<\/p>\n<p>Regulatorisk overholdelse er derfor ikke blot et juridisk krav \u2013 det er et fundament for effektiv laboratoriedrift.<\/p>\n<p>Dokumentation som compliance-v\u00e6rkt\u00f8j<\/p>\n<p>Dokumentation i laboratoriet er kernen i compliance. Uden dokumentation kan en aktivitet ikke anses som udf\u00f8rt.<\/p>\n<p>Vigtige dokumenttyper omfatter:<\/p>\n<ul>\n<li>SOP\u2019er og arbejdsinstruktioner<\/li>\n<li>Batch records og r\u00e5data<\/li>\n<li>Kalibrerings- og vedligeholdelsesrapporter<\/li>\n<li>Tr\u00e6ningsregistreringer<\/li>\n<li>Leverand\u00f8rgodkendelser<\/li>\n<\/ul>\n<p>Dataintegritet i laboratorier er s\u00e6rligt kritisk i GMP-milj\u00f8er. ALCOA-principperne (Attributable, Legible, Contemporaneous, Original, Accurate) er centrale for at sikre, at data er valide og inspektionssikre.<\/p>\n<p>Digital dokumentstyring kan styrke compliance ved at reducere risikoen for for\u00e6ldede dokumenter og manglende versionskontrol.<\/p>\n<h2>Hvordan leverand\u00f8rer p\u00e5virker compliance<\/h2>\n<p>Leverand\u00f8rstyring er en integreret del af compliance i laboratorier. Udstyr, reagenser og forbrugsvarer skal leve op til dokumenterede krav.<\/p>\n<p>Dette indeb\u00e6rer:<\/p>\n<ul>\n<li>Kvalificering og godkendelse af leverand\u00f8rer<\/li>\n<li>Dokumentation for kvalitet og sporbarhed<\/li>\n<li>Certifikater (CoA, CoC)<\/li>\n<li>Periodisk evaluering<\/li>\n<\/ul>\n<p>Mangelfuld leverand\u00f8rkontrol kan f\u00f8re til regulatoriske afvigelser. Derfor b\u00f8r leverand\u00f8rstyring v\u00e6re en del af laboratoriets kvalitetssystem.<\/p>\n<h2>Compliance i forhold til forbrugsvarer<\/h2>\n<p>Forbrugsvarer spiller en st\u00f8rre rolle i compliance, end mange antager. Sporbarhed p\u00e5 lot-nummer, korrekt opbevaring og dokumentation af anvendelse er afg\u00f8rende.<\/p>\n<p>I GMP-laboratorier skal forbrugsvarer ofte v\u00e6re kvalificerede og dokumenterede. Forkert h\u00e5ndtering kan kompromittere b\u00e5de analyseresultater og regulatorisk overholdelse.<\/p>\n<p>Standardisering af indk\u00f8b og lagerstyring styrker b\u00e5de compliance og driftseffektivitet.<\/p>\n<p>Intern kontrol vs. ekstern audit<\/p>\n<p>Intern audit i laboratorier er et proaktivt v\u00e6rkt\u00f8j til at identificere svagheder f\u00f8r en myndighedsinspektion.<\/p>\n<p>Forskellen mellem intern kontrol og ekstern audit:<\/p>\n<ul>\n<li>Intern audit er l\u00f8bende og forbedringsorienteret<\/li>\n<li>Ekstern audit er vurderende og regulatorisk<\/li>\n<li>Intern kontrol fokuserer p\u00e5 forebyggelse<\/li>\n<li>Ekstern audit fokuserer p\u00e5 overholdelse<\/li>\n<\/ul>\n<p>Effektiv audit-forberedelse reducerer stress og minimerer risikoen for kritiske observationer.<\/p>\n<h2>Compliance i GMP-milj\u00f8er<\/h2>\n<p>Compliance i GMP-laboratorier er s\u00e6rligt reguleret. Her er kravene til dokumentation, sporbarhed og validering omfattende.<\/p>\n<p>Centrale elementer i GMP-compliance:<\/p>\n<ul>\n<li>Validerede analysemetoder<\/li>\n<li>IQ\/OQ\/PQ af udstyr<\/li>\n<li>Streng change control<\/li>\n<li>Dokumenteret tr\u00e6ning<\/li>\n<li>Afvigelsesh\u00e5ndtering og CAPA<\/li>\n<\/ul>\n<p>Myndigheder som EMA og FDA forventer fuld sporbarhed og dokumenteret dataintegritet.<\/p>\n<h2>Hvordan tr\u00e6ning underst\u00f8tter compliance<\/h2>\n<p>Tr\u00e6ning i laboratorier er en foruds\u00e6tning for compliance. Medarbejdere skal forst\u00e5 b\u00e5de procedurer og baggrunden for dem.<\/p>\n<p>Effektiv tr\u00e6ning indeb\u00e6rer:<\/p>\n<ul>\n<li>Introduktion til kvalitetsstyringssystemet<\/li>\n<li>L\u00f8bende opdatering ved \u00e6ndringer<\/li>\n<li>Dokumenteret kompetencevurdering<\/li>\n<li>Klar ansvarsfordeling<\/li>\n<\/ul>\n<p>Uden dokumenteret tr\u00e6ning kan selv veludformede procedurer ikke sikre regulatorisk overholdelse.<\/p>\n<h2>Compliance som l\u00f8bende proces \u2013 ikke engangsopgave<\/h2>\n<p>Compliance er dynamisk. Nye regulatoriske krav, opdaterede standarder og teknologiske \u00e6ndringer kr\u00e6ver l\u00f8bende tilpasning.<\/p>\n<p>Et laboratorie b\u00f8r arbejde med:<\/p>\n<ul>\n<li>Kontinuerlig forbedring<\/li>\n<li>Risikobaseret tilgang<\/li>\n<li>Regelm\u00e6ssig gennemgang af SOP\u2019er<\/li>\n<li>Systematisk opf\u00f8lgning p\u00e5 audits<\/li>\n<\/ul>\n<p>Compliance management i laboratorier er derfor en integreret del af den daglige drift \u2013 ikke et projekt, der afsluttes efter en inspektion.<\/p>\n<h2>FAQ \u2013 Compliance i laboratorier<\/h2>\n<h3>1. Hvad er compliance i et laboratorium?<\/h3>\n<p>Compliance er systematisk overholdelse af regulatoriske krav, standarder og interne procedurer.<\/p>\n<h3>2. Hvilke standarder g\u00e6lder for laboratorier?<\/h3>\n<p>Typisk GMP, GLP, ISO 17025 og ISO 15189 afh\u00e6ngigt af laboratoriets type.<\/p>\n<h3>3. Hvad er de mest almindelige compliance-fejl?<\/h3>\n<p>Manglende dokumentation, utilstr\u00e6kkelig sporbarhed og mangelfuld udstyrskalibrering.<\/p>\n<h3>4. Hvorfor er dokumentation s\u00e5 vigtig?<\/h3>\n<p>Uden dokumentation kan en aktivitet ikke anses som udf\u00f8rt eller verificeret.<\/p>\n<h3>5. Hvad betyder dataintegritet?<\/h3>\n<p>At data er korrekte, sporbare og beskyttet mod uautoriserede \u00e6ndringer.<\/p>\n<h3>6. Hvordan p\u00e5virker leverand\u00f8rer compliance?<\/h3>\n<p>Utilstr\u00e6kkelig leverand\u00f8rkontrol kan f\u00f8re til regulatoriske afvigelser.<\/p>\n<h3>7. Hvad er forskellen p\u00e5 intern og ekstern audit?<\/h3>\n<p>Intern audit er forbedringsorienteret; ekstern audit vurderer regulatorisk overholdelse.<\/p>\n<h3>8. Hvordan sikres compliance i GMP-laboratorier?<\/h3>\n<p>Gennem validering, dokumentation, tr\u00e6ning og streng change control.<\/p>\n<h3>9. Hvor ofte b\u00f8r man gennemf\u00f8re intern audit?<\/h3>\n<p>Typisk \u00e5rligt eller risikobaseret afh\u00e6ngigt af aktivitetens kritikalitet.<\/p>\n<h3>10. Er compliance en engangsopgave?<\/h3>\n<p>\u00a0<\/p>\n<p>Nej, compliance er en kontinuerlig proces, der kr\u00e6ver l\u00f8bende opdatering og forbedring.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f80d600 e-flex e-con-boxed e-con e-parent\" data-id=\"f80d600\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c31d604 e-flex e-con-boxed e-con e-parent\" data-id=\"c31d604\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-720cd30 e-con-full e-flex e-con e-child\" data-id=\"720cd30\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f94f9b5 elementor-widget elementor-widget-heading\" data-id=\"f94f9b5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">M\u00f8d vores ekspert<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-673c6c3 elementor-widget elementor-widget-text-editor\" data-id=\"673c6c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Vi er en dansk familieejet virksomhed med 43 medarbejdere, der br\u00e6nder for at give vores kunder en professionel service, der matcher vores kernekompetencer, som er salg, service og kalibrering af laboratorie- og pipetteringsudstyr.<\/p>\n<p>Trivsel og performance er parametre, som har stor betydning for os. Vores medarbejdere tager ansvar for deres opgaver, og er altid klar til hj\u00e6lpe og vejlede vores kunder med r\u00e5dgivning og service p\u00e5 et professionelt og h\u00f8jt niveau.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5dd2601 e-con-full e-flex e-con e-child\" data-id=\"5dd2601\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-db0777c elementor-widget elementor-widget-shortcode\" data-id=\"db0777c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><article class=\"staff-card card staff-card-layout-horizontal\">\r\n                            <div class=\"card-media staff-card-media-bg\" style=\"background-image: url('https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-content\/uploads\/2023\/08\/6K2A0745-Sabine.jpg');\" aria-hidden=\"true\"><\/div>\r\n                        <div class=\"card-body\">\r\n                                    <p class=\"card-kicker\">Kommerciel<\/p>\r\n                                <h3 class=\"card-title\">Sabine K\u00e4hler Augustesen<\/h3>\r\n                                    <p class=\"card-excerpt\">Forretningsudvikler<\/p>\r\n                                                    <div class=\"card-actions\">\r\n                                                    <a href=\"mailto:sk@dandiag.dk\">sk@dandiag.dk<\/a>\r\n                                                                            <a href=\"tel:+4531169067\">+45 31 16 90 67<\/a>\r\n                                            <\/div>\r\n                                                    <p class=\"card-excerpt\"><\/p>\r\n                            <\/div>\r\n        <\/article><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Compliance i laboratorier &#8211; krav, dokumentation og drift I vores artikelarkiv kan du udforske n\u00f8gleaspekter inden for kvalitetssikring og overholdelse af regulativer inden for laboratorieudstyr og praksis. Opdag hvordan Cubis II MCA-software og Cubis\u00ae II balanceserie kan hj\u00e6lpe dig med at opn\u00e5 overholdelse og forbedre n\u00f8jagtighed og effektivitet i dit arbejde. Find mere om: 21&#8230;<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":129,"menu_order":48,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-416","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Compliance - Dandiag (Demo)<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/\" \/>\n<meta property=\"og:locale\" content=\"da_DK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Compliance - Dandiag (Demo)\" \/>\n<meta property=\"og:description\" content=\"Compliance i laboratorier &#8211; krav, dokumentation og drift I vores artikelarkiv kan du udforske n\u00f8gleaspekter inden for kvalitetssikring og overholdelse af regulativer inden for laboratorieudstyr og praksis. Opdag hvordan Cubis II MCA-software og Cubis\u00ae II balanceserie kan hj\u00e6lpe dig med at opn\u00e5 overholdelse og forbedre n\u00f8jagtighed og effektivitet i dit arbejde. Find mere om: 21...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/\" \/>\n<meta property=\"og:site_name\" content=\"Dandiag (Demo)\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/Dandiag.dk\/\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-18T10:13:34+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimeret l\u00e6setid\" \/>\n\t<meta name=\"twitter:data1\" content=\"8 minutter\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/applikationer\\\/compliance\\\/\",\"url\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/applikationer\\\/compliance\\\/\",\"name\":\"Compliance - Dandiag (Demo)\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/#website\"},\"datePublished\":\"2023-10-10T09:42:45+00:00\",\"dateModified\":\"2026-04-18T10:13:34+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/applikationer\\\/compliance\\\/#breadcrumb\"},\"inLanguage\":\"da-DK\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/applikationer\\\/compliance\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/applikationer\\\/compliance\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Forside\",\"item\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Applikationer\",\"item\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/applikationer\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Compliance\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/#website\",\"url\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/\",\"name\":\"Dandiag (Demo)\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"da-DK\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/#organization\",\"name\":\"Dandiag (Demo)\",\"url\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"da-DK\",\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/Dandiag_logo.png\",\"contentUrl\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/Dandiag_logo.png\",\"width\":1828,\"height\":418,\"caption\":\"Dandiag (Demo)\"},\"image\":{\"@id\":\"https:\\\/\\\/demo.hviiddigital.dk\\\/dandiag.dk\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/Dandiag.dk\\\/\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/dandiag\\\/\",\"https:\\\/\\\/www.youtube.com\\\/channel\\\/UCp0lYGCUAIQ3OVIYK2868PQ\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Compliance - Dandiag (Demo)","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/","og_locale":"da_DK","og_type":"article","og_title":"Compliance - Dandiag (Demo)","og_description":"Compliance i laboratorier &#8211; krav, dokumentation og drift I vores artikelarkiv kan du udforske n\u00f8gleaspekter inden for kvalitetssikring og overholdelse af regulativer inden for laboratorieudstyr og praksis. Opdag hvordan Cubis II MCA-software og Cubis\u00ae II balanceserie kan hj\u00e6lpe dig med at opn\u00e5 overholdelse og forbedre n\u00f8jagtighed og effektivitet i dit arbejde. Find mere om: 21...","og_url":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/","og_site_name":"Dandiag (Demo)","article_publisher":"https:\/\/www.facebook.com\/Dandiag.dk\/","article_modified_time":"2026-04-18T10:13:34+00:00","twitter_card":"summary_large_image","twitter_misc":{"Estimeret l\u00e6setid":"8 minutter"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/","url":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/","name":"Compliance - Dandiag (Demo)","isPartOf":{"@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/#website"},"datePublished":"2023-10-10T09:42:45+00:00","dateModified":"2026-04-18T10:13:34+00:00","breadcrumb":{"@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/#breadcrumb"},"inLanguage":"da-DK","potentialAction":[{"@type":"ReadAction","target":["https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/compliance\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Forside","item":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/"},{"@type":"ListItem","position":2,"name":"Applikationer","item":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/applikationer\/"},{"@type":"ListItem","position":3,"name":"Compliance"}]},{"@type":"WebSite","@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/#website","url":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/","name":"Dandiag (Demo)","description":"","publisher":{"@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"da-DK"},{"@type":"Organization","@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/#organization","name":"Dandiag (Demo)","url":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/","logo":{"@type":"ImageObject","inLanguage":"da-DK","@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/#\/schema\/logo\/image\/","url":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-content\/uploads\/2023\/08\/Dandiag_logo.png","contentUrl":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-content\/uploads\/2023\/08\/Dandiag_logo.png","width":1828,"height":418,"caption":"Dandiag (Demo)"},"image":{"@id":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/Dandiag.dk\/","https:\/\/www.linkedin.com\/company\/dandiag\/","https:\/\/www.youtube.com\/channel\/UCp0lYGCUAIQ3OVIYK2868PQ"]}]}},"_links":{"self":[{"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/pages\/416","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/comments?post=416"}],"version-history":[{"count":16,"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/pages\/416\/revisions"}],"predecessor-version":[{"id":12343,"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/pages\/416\/revisions\/12343"}],"up":[{"embeddable":true,"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/pages\/129"}],"wp:attachment":[{"href":"https:\/\/demo.hviiddigital.dk\/dandiag.dk\/wp-json\/wp\/v2\/media?parent=416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}