{"id":13622,"date":"2025-01-10T12:07:57","date_gmt":"2025-01-10T11:07:57","guid":{"rendered":"https:\/\/q-finity.de\/?p=13622"},"modified":"2025-01-10T12:10:32","modified_gmt":"2025-01-10T11:10:32","slug":"development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/","title":{"rendered":"Development of a validation framework for computerized systems incl. introduction and validation of a study management system"},"content":{"rendered":"<div>\n<h2>The project<\/h2>\n<p>This project, at a university hospital, involved the introduction and validation of a study management system, including the development of a framework for the validation of computerized systems and the training of staff. A central component was the implementation of a vendor <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> as part of the vendor qualification <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> to ensure that all external providers met the required standards.<\/p>\n<p>In addition, a customized study management system was introduced and validated to improve the efficiency and <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> of the study processes. The study center received ongoing guidance on regulatory requirements and best practices throughout the project to ensure compliance with all applicable regulations.<\/p>\n<h2>The goal<\/h2>\n<p>Our main objective of the project was to introduce and comprehensively validate a modern study management system that would significantly increase the efficiency and transparency of administrative processes within the study center. As part of this project, particular attention was paid to ensuring that the study center was continuously and regularly advised on current regulatory requirements at both national and international level. In addition, the advice was to ensure that the latest best practices in the field of study management were always taken into account in order to enable continuous improvement of internal processes and to meet the necessary high <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> standards. Another important element was to ensure that the implementation of the system is flexible enough to accommodate future regulatory changes and industry-specific developments.<\/p>\n<h2>Any questions about validating a study management system?<\/h2>\n<p>What measures were implemented at the customer&rsquo;s site to successfully introduce a validation framework?<\/p>\n<ul>\n<li>A validation framework was developed and implemented that was tailored to the customer&rsquo;s specific requirements. In addition to adapting the framework, the implementation also included extensive training and ongoing project support for the customer&rsquo;s employees. The aim of these measures was to provide the customer team with comprehensive training in dealing with the newly introduced processes and regulatory requirements. In addition, acceptance and understanding of the various controls and processes was to be strengthened through active cooperation at all levels in order to enable sustainable <a href=\"https:\/\/q-finity.de\/en\/glossar\/integration\/\" target=\"_self\" title=\"Integration describes the building of hardware and\/or implementation of software components to create a complete system. Integration tests check the function and interaction of the individual components. For more information about integration contact us here.\" class=\"encyclopedia\">integration<\/a> of the framework into the daily routine.<\/li>\n<\/ul>\n<p>What steps were taken in the project to ensure compliance with applicable requirements and best practices?<\/p>\n<ul>\n<li>During the course of the project, the client&rsquo;s team was continuously advised on current requirements and best practices to ensure compliance with all relevant standards. This included the implementation and validation of a study management system and the qualification of the infrastructure. In addition, <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> supported the project team in the qualification of suppliers and the associated documentation. The focus was on advising and supporting the team in the areas of <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services. If you need&hellip;\" class=\"encyclopedia\">quality management<\/a>, CSV and GxP processes as well as developing and implementing the validation strategy and creating the necessary validation documentation.<\/li>\n<\/ul>\n<p style=\"font-weight: 400;\">Do you need help with a similar project? Then please contact us using our <a href=\"https:\/\/q-finity.de\/en\/contact\/\">contact form<\/a>. You can find more information about our services under Service. Feel free to take a look there.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The project This project, at a university hospital, involved the introduction and validation of a study management system, including the development of a framework for the validation of computerized systems and the training of staff. A central component was the implementation of a vendor audit as part of the vendor qualification process to ensure that [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[48],"tags":[],"class_list":["post-13622","post","type-post","status-publish","format-standard","hentry","category-project-news"],"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>Validierung eines Studienmanagementsystems<\/title>\n<meta name=\"description\" content=\"This project deals with the validation of a study management system; development of a framework for the validation of computer-aided systems\" \/>\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-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/\" \/>\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 for computerized systems incl. introduction and validation of a study management system\" \/>\n<meta property=\"og:description\" content=\"This project deals with the validation of a study management system; development of a framework for the validation of computer-aided systems\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/\" \/>\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=\"2025-01-10T11:07:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-10T11:10:32+00:00\" \/>\n<meta name=\"author\" content=\"Maike Henrichmann\" \/>\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=\"Maike Henrichmann\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\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-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/\"},\"author\":{\"name\":\"Maike Henrichmann\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/9f304da5294d2d15c3f03d2521c47921\"},\"headline\":\"Development of a validation framework for computerized systems incl. introduction and validation of a study management system\",\"datePublished\":\"2025-01-10T11:07:57+00:00\",\"dateModified\":\"2025-01-10T11:10:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/\"},\"wordCount\":509,\"publisher\":{\"@id\":\"https:\/\/q-finity.de\/en\/#organization\"},\"articleSection\":[\"Project News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/\",\"url\":\"https:\/\/q-finity.de\/en\/development-of-a-validation-framework-for-computerized-systems-incl-introduction-and-validation-of-a-study-management-system\/\",\"name\":\"Validierung eines Studienmanagementsystems\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2025-01-10T11:07:57+00:00\",\"dateModified\":\"2025-01-10T11:10:32+00:00\",\"description\":\"This project deals with the validation of a study management system; 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