{"id":5292,"date":"2021-02-07T16:00:00","date_gmt":"2021-02-07T15:00:00","guid":{"rendered":"https:\/\/q-finity.de\/auditierung-des-studienprozesses-eines-universitaeren-instituts\/"},"modified":"2024-11-11T19:17:48","modified_gmt":"2024-11-11T18:17:48","slug":"auditing-the-clinical-data-management-process-of-a-university-institute-including-checking-the-validation-documents-of-an-open-source-edc-software","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/auditing-the-clinical-data-management-process-of-a-university-institute-including-checking-the-validation-documents-of-an-open-source-edc-software\/","title":{"rendered":"Auditing the clinical data management process of a university institute"},"content":{"rendered":"<p>A university institute (CRO) wished to perform clinical trials with an Open-Source electronic <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> capture (EDC) system. <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; was commissioned by the QA department of the university to perform an <a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a> concerning the compliance of the validation project and the validation documents for the EDC system, as well as other regulatory documents necessary for conducting clinical trials.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A university institute (CRO) wished to perform clinical trials with an Open-Source electronic data capture (EDC) system. QFINITY\u221e was commissioned by the QA department of the university to perform an audit concerning the compliance of the validation project and the validation documents for the EDC system, as well as other regulatory documents necessary for conducting [&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-5292","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>Studies processes Auditing with QFINITY<\/title>\n<meta name=\"description\" content=\"QFINITY &#187; Auditing the clinical data management process of a university institute\" \/>\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\/auditing-the-clinical-data-management-process-of-a-university-institute-including-checking-the-validation-documents-of-an-open-source-edc-software\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Auditing the clinical data management process of a university institute\" \/>\n<meta property=\"og:description\" content=\"QFINITY &#187; 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