{"id":35,"date":"2026-04-12T19:55:25","date_gmt":"2026-04-12T19:55:25","guid":{"rendered":"https:\/\/qualityengineering.dk\/?page_id=35"},"modified":"2026-04-13T20:08:34","modified_gmt":"2026-04-13T20:08:34","slug":"vidensdeling-og-indsigter","status":"publish","type":"page","link":"https:\/\/qualityengineering.dk\/?page_id=35","title":{"rendered":"Vidensdeling og indsigter"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Her deler jeg mine observationer, indsigter og perspektiver p\u00e5 QRM, validering og deres krydsfelt med engineering og regulatorisk. M\u00e5let er at g\u00f8re risikobaseret life cycle management mere h\u00e5ndgribeligt og flytte fokus fra teori til praksis, hvor det skaber reel v\u00e6rdi.<\/p>\n\n\n\n<div class=\"wp-block-query is-layout-flow wp-block-query-is-layout-flow\"><ul class=\"columns-3 wp-block-post-template is-layout-grid wp-container-core-post-template-is-layout-7e964c02 wp-block-post-template-is-layout-grid\"><li class=\"wp-block-post post-59 post type-post status-publish format-standard hentry category-quality-risk-management category-validering-og-kvalificering\">\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\" style=\"padding-top:30px;padding-right:30px;padding-bottom:30px;padding-left:30px\"><h2 class=\"wp-block-post-title\"><a href=\"https:\/\/qualityengineering.dk\/?p=59\" target=\"_self\" >Skalerbarhed: Stop med at validere alt p\u00e5 samme m\u00e5de\u200b<\/a><\/h2>\n\n<div class=\"wp-block-post-excerpt\"><p class=\"wp-block-post-excerpt__excerpt\">\u200bVi har alle pr\u00f8vet det. Et projekt, hvor en mindre \u00e6ndring p\u00e5 et eksisterende anl\u00e6g udl\u00f8ser den samme store forkromede dokumentpakke, som hvis vi byggede en hel fabrik fra bunden. Vi k\u00f8rer slavisk igennem URS, DQ, IQ, OQ og PQ, selvom sund fornuft fort\u00e6ller os, at halvdelen af arbejdet ikke skaber nogen reel v\u00e6rdi for&hellip; <\/p><\/div>\n\n<div class=\"wp-block-post-date\"><time datetime=\"2026-05-01T20:38:32+00:00\">maj 1, 2026<\/time><\/div><\/div>\n\n<\/li><li class=\"wp-block-post post-56 post type-post status-publish format-standard hentry category-quality-risk-management category-validering-og-kvalificering tag-cqv tag-csv tag-validering\">\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\" style=\"padding-top:30px;padding-right:30px;padding-bottom:30px;padding-left:30px\"><h2 class=\"wp-block-post-title\"><a href=\"https:\/\/qualityengineering.dk\/?p=56\" target=\"_self\" >Validering skal skabe v\u00e6rdi \u2013 ikke &#8220;Validation PTSD&#8221;<\/a><\/h2>\n\n<div class=\"wp-block-post-excerpt\"><p class=\"wp-block-post-excerpt__excerpt\">&#8220;Validering.\u201d\u200b N\u00e5r det ord bliver n\u00e6vnt til et projektm\u00f8de, kan man n\u00e6sten h\u00f8re det kollektive suk. \u00d8jnene s\u00f8ger mod udgangen, og energien forlader rummet hurtigere, end man kan n\u00e5 at sige compliance.\u200b For projektlederen lyder det som en forsinkelse. For projektejeren lyder det som om, budgettet netop er fordoblet. For ingeni\u00f8ren lyder det som et&hellip; <\/p><\/div>\n\n<div class=\"wp-block-post-date\"><time datetime=\"2026-04-20T19:40:03+00:00\">april 20, 2026<\/time><\/div><\/div>\n\n<\/li><li class=\"wp-block-post post-47 post type-post status-publish format-standard hentry category-validering-og-kvalificering tag-cqv\">\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\" style=\"padding-top:30px;padding-right:30px;padding-bottom:30px;padding-left:30px\"><h2 class=\"wp-block-post-title\"><a href=\"https:\/\/qualityengineering.dk\/?p=47\" target=\"_self\" >Validering i virkeligheden: Da elbilen blev min st\u00f8rste stresstest<\/a><\/h2>\n\n<div class=\"wp-block-post-excerpt\"><p class=\"wp-block-post-excerpt__excerpt\">De fleste i branchen kender f\u00f8lelsen. Man n\u00e6vner ordet \u201cvalidering\u201d til et projektm\u00f8de, og straks m\u00e6rker man energien forlade rummet. Vi ser bjerge af papir for os \u2013 dokumentation for dokumentationens skyld. Men validering er i virkeligheden bare sund fornuft sat i system. For at bevise det vil jeg tage dig med igennem mit eget&hellip; <\/p><\/div>\n\n<div class=\"wp-block-post-date\"><time datetime=\"2026-04-20T19:32:14+00:00\">april 20, 2026<\/time><\/div><\/div>\n\n<\/li><li class=\"wp-block-post post-42 post type-post status-publish format-standard hentry category-validering-og-kvalificering\">\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\" style=\"padding-top:30px;padding-right:30px;padding-bottom:30px;padding-left:30px\"><h2 class=\"wp-block-post-title\"><a href=\"https:\/\/qualityengineering.dk\/?p=42\" target=\"_self\" >Den moderne opskrift p\u00e5 effektiv validering<\/a><\/h2>\n\n<div class=\"wp-block-post-excerpt\"><p class=\"wp-block-post-excerpt__excerpt\">\u200bI mange \u00e5r blev validering og kvalificering set som en line\u00e6r tjekliste: Planl\u00e6g, udf\u00f8r, arkiv\u00e9r. Men i et moderne GxP-milj\u00f8 er denne tilgang b\u00e5de tung og risikabel. Hvis vi vil have processer, der rent faktisk fungerer \u2013 og som er nemme at vedligeholde \u2013 skal vi kigge p\u00e5 regnestykket: QRM + Life Cycle Management =&hellip; <\/p><\/div>\n\n<div class=\"wp-block-post-date\"><time datetime=\"2026-04-13T20:03:07+00:00\">april 13, 2026<\/time><\/div><\/div>\n\n<\/li><li class=\"wp-block-post post-39 post type-post status-publish format-standard hentry category-quality-risk-management tag-quality-risk-management\">\n\n<div class=\"wp-block-group is-layout-flow wp-block-group-is-layout-flow\" style=\"padding-top:30px;padding-right:30px;padding-bottom:30px;padding-left:30px\"><h2 class=\"wp-block-post-title\"><a href=\"https:\/\/qualityengineering.dk\/?p=39\" target=\"_self\" >Grundstenen i QRM: Hvorfor din risikovurdering d\u00f8r uden en klar kontekst<\/a><\/h2>\n\n<div class=\"wp-block-post-excerpt\"><p class=\"wp-block-post-excerpt__excerpt\">En af de hyppigste \u00e5rsager til, at risikovurderinger i GxP-milj\u00f8er k\u00f8rer af sporet, bliver for tunge eller ender i endel\u00f8se diskussioner, er hverken mangel p\u00e5 teknisk indsigt eller d\u00e5rlige skemaer.\u200b Det er manglende forberedelse.\u200b Jeg oplever ofte teams, der har sv\u00e6rt ved at begr\u00e6nse sig, n\u00e5r de f\u00f8rst sidder i m\u00f8delokalet. Diskussionerne breder sig, risiciene&hellip; <\/p><\/div>\n\n<div class=\"wp-block-post-date\"><time datetime=\"2026-04-13T19:46:03+00:00\">april 13, 2026<\/time><\/div><\/div>\n\n<\/li><\/ul><\/div>\n\n\n<ul class=\"wp-block-latest-posts__list is-grid columns-3 wp-block-latest-posts\"><li><a class=\"wp-block-latest-posts__post-title\" href=\"https:\/\/qualityengineering.dk\/?p=59\">Skalerbarhed: Stop med at validere alt p\u00e5 samme m\u00e5de\u200b<\/a><\/li>\n<li><a class=\"wp-block-latest-posts__post-title\" href=\"https:\/\/qualityengineering.dk\/?p=56\">Validering skal skabe v\u00e6rdi \u2013 ikke &#8220;Validation PTSD&#8221;<\/a><\/li>\n<li><a class=\"wp-block-latest-posts__post-title\" href=\"https:\/\/qualityengineering.dk\/?p=47\">Validering i virkeligheden: Da elbilen blev min st\u00f8rste stresstest<\/a><\/li>\n<li><a class=\"wp-block-latest-posts__post-title\" href=\"https:\/\/qualityengineering.dk\/?p=42\">Den moderne opskrift p\u00e5 effektiv validering<\/a><\/li>\n<li><a class=\"wp-block-latest-posts__post-title\" href=\"https:\/\/qualityengineering.dk\/?p=39\">Grundstenen i QRM: Hvorfor din risikovurdering d\u00f8r uden en klar kontekst<\/a><\/li>\n<\/ul>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Her deler jeg mine observationer, indsigter og perspektiver p\u00e5 QRM, validering og deres krydsfelt med engineering og regulatorisk. M\u00e5let er at g\u00f8re risikobaseret life cycle management mere h\u00e5ndgribeligt og flytte fokus fra teori til praksis, hvor det skaber reel v\u00e6rdi.<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-35","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=\/wp\/v2\/pages\/35","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=35"}],"version-history":[{"count":4,"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=\/wp\/v2\/pages\/35\/revisions"}],"predecessor-version":[{"id":45,"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=\/wp\/v2\/pages\/35\/revisions\/45"}],"wp:attachment":[{"href":"https:\/\/qualityengineering.dk\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=35"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}