{"id":789,"date":"2019-10-08T22:33:17","date_gmt":"2019-10-08T20:33:17","guid":{"rendered":"https:\/\/borgensgaard-consulting.dk\/?page_id=789"},"modified":"2020-01-08T21:23:49","modified_gmt":"2020-01-08T20:23:49","slug":"validering-af-software","status":"publish","type":"page","link":"https:\/\/borgensgaard-consulting.dk\/da\/services\/quality-management-goer-tingene-rigtigt\/validering-af-software\/","title":{"rendered":"Validering af Software"},"content":{"rendered":"<div id=\"pl-789\"  class=\"panel-layout\" ><div id=\"pg-789-0\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-789-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-789-0-0-0\" class=\"so-panel widget widget_sow-image panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-image so-widget-sow-image-default-dbf295114b96-789\"\n\t\t\t\n\t\t>\n\n<div class=\"sow-image-container\">\n\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Software-Validering-1.jpg\" width=\"1105\" height=\"468\" srcset=\"https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Software-Validering-1.jpg 1105w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Software-Validering-1-300x127.jpg 300w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Software-Validering-1-768x325.jpg 768w, https:\/\/borgensgaard-consulting.dk\/wp-content\/uploads\/2019\/10\/Software-Validering-1-1024x434.jpg 1024w\" sizes=\"(max-width: 1105px) 100vw, 1105px\" title=\"Software Validering\" alt=\"Validering af Software\" \t\tclass=\"so-widget-image\"\/>\n\t<\/div>\n\n<\/div><\/div><\/div><\/div><div id=\"pg-789-1\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-789-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-789-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<h2>Validering af Software<\/h2>\n<p>Der er software i n\u00e6sten alt udstyr, og det kan v\u00e6re en v\u00e6sentlig kilde til fejl i processen.<\/p>\n<p>Producenter af medicin og medicinsk udstyr skal derfor validere software, som er GxP kritisk. De samme krav er g\u00e6ldende for processer, som er lagt ud til leverand\u00f8rer.<\/p>\n<p>Software betragtes som GxP kritisk, n\u00e5r det kan have indflydelse p\u00e5 patientsikkerhed, produktkvalitet og dataintegritet.<\/p>\n<p>Jeg kan hj\u00e6lpe jer med at kortl\u00e6gge alt jeres software og etablere jeres proces for software validering af separate software systemer og software, som er integreret i procesudstyr.<\/p>\n<p>Jeg arbejder med en risikobaseret tilgang til software validering baseret p\u00e5 GAMP 5 og i henhold til kravene i:<\/p>\n<ul>\n<li>ISO 13485 &amp; ISO 15378<\/li>\n<li>FDA 21 CFR Part 11<\/li>\n<li>FDA: Data Integrity and Compliance With Drug CGMP<\/li>\n<li>EU guidance for Good Manufacturing Practice \u2013 appendix 11 &amp; 15<\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Validering af Software Der er software i n\u00e6sten alt udstyr, og det kan v\u00e6re en v\u00e6sentlig kilde til fejl i [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":654,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"class_list":["post-789","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - 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