{"id":5288,"date":"2021-02-08T15:58:00","date_gmt":"2021-02-08T14:58:00","guid":{"rendered":"https:\/\/q-finity.de\/aufbau-eines-validierungsrahmenwerks-und-validierung-einer-open-source-edc-software\/"},"modified":"2024-11-11T19:07:49","modified_gmt":"2024-11-11T18:07:49","slug":"development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/","title":{"rendered":"Development of a validation framework and validation of Open-Source EDC software for a European physicians\u2019 association"},"content":{"rendered":"<p>A European contract research organization (CRO), associated with an association of European physicians, needed to validate its Open-Source <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> collection system (EDC) for conducting clinical trials. <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a>&infin; trained the organization&rsquo;s employees in the basics concerning GxP, CSV and Part 11, and provided the necessary SOPs and templates for validation and operation, while supporting the ongoing validation of the EDC system (OpenClinica) by coaching.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A European contract research organization (CRO), associated with an association of European physicians, needed to validate its Open-Source data collection system (EDC) for conducting clinical trials. QFINITY\u221e trained the organization\u2019s employees in the basics concerning GxP, CSV and Part 11, and provided the necessary SOPs and templates for validation and operation, while supporting the ongoing [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-5288","post","type-post","status-publish","format-standard","hentry","category-news-category"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EDC software and validation with QFINITY<\/title>\n<meta name=\"description\" content=\"QFINITY &#187; Development of a validation framework and validation of Open-Source EDC software for a European physicians\u2019 association\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Development of a validation framework and validation of Open-Source EDC software for a European physicians\u2019 association\" \/>\n<meta property=\"og:description\" content=\"QFINITY &#187; Development of a validation framework and validation of Open-Source EDC software for a European physicians\u2019 association\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/QFINITY\" \/>\n<meta property=\"article:published_time\" content=\"2021-02-08T14:58:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-11T18:07:49+00:00\" \/>\n<meta name=\"author\" content=\"lukas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:site\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"lukas\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/\"},\"author\":{\"name\":\"lukas\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/a08359276499be6819272ca77a4ebd86\"},\"headline\":\"Development of a validation framework and validation of Open-Source EDC software for a European physicians\u2019 association\",\"datePublished\":\"2021-02-08T14:58:00+00:00\",\"dateModified\":\"2024-11-11T18:07:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/\"},\"wordCount\":79,\"publisher\":{\"@id\":\"https:\/\/q-finity.de\/en\/#organization\"},\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/\",\"url\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-and-validation-of-open-source-edc-software-for-a-european-physicians-association\/\",\"name\":\"EDC software and validation with QFINITY\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2021-02-08T14:58:00+00:00\",\"dateModified\":\"2024-11-11T18:07:49+00:00\",\"description\":\"QFINITY &#187; 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