{"id":14470,"date":"2026-04-08T14:22:46","date_gmt":"2026-04-08T12:22:46","guid":{"rendered":"https:\/\/q-finity.de\/?p=14470"},"modified":"2026-04-08T14:27:19","modified_gmt":"2026-04-08T12:27:19","slug":"global-qms-concept-case-study","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/global-qms-concept-case-study\/","title":{"rendered":"Global QMS concept for an international pharmaceutical company: design and implementation"},"content":{"rendered":"<p data-section-id=\"1ehl6qz\" data-start=\"0\" data-end=\"20\">This case study focuses on the design and implementation of a global QMS concept for an international pharmaceutical company.<\/p>\n<h2 data-section-id=\"1ehl6qz\" data-start=\"0\" data-end=\"20\">Problem Statement<\/h2>\n<p data-start=\"22\" data-end=\"302\">The client is an internationally operating company in the field of pharmaceutical active ingredient research. Its services include the research and development of new pharmaceutical compounds as well as the development of software platforms for specialized methods in this domain.<\/p>\n<p data-start=\"304\" data-end=\"498\">Due to significant growth through acquisitions in the past, it became necessary to consolidate the various <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> approaches into a harmonized global <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> System (QMS).<\/p>\n<p data-start=\"500\" data-end=\"547\">To achieve this objective, the client required:<\/p>\n<ul data-start=\"549\" data-end=\"1206\">\n<li data-section-id=\"fucdn9\" data-start=\"549\" data-end=\"720\">Development of a global QMS concept that integrates the requirements of existing QMS with relevant standards such as GAMP and ITIL while ensuring regulatory compliance<\/li>\n<li data-section-id=\"gkiebb\" data-start=\"721\" data-end=\"804\">Evaluation of existing inconsistencies and development of appropriate solutions<\/li>\n<li data-section-id=\"1uzbmdc\" data-start=\"805\" data-end=\"1030\">Creation of policies, directives, SOPs, work instructions, and required templates for the areas of: Infrastructure, Software Development, <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a> based on the developed QMS concept<\/li>\n<li data-section-id=\"13jcs5\" data-start=\"1031\" data-end=\"1118\">Development of a training concept and training materials for the global QMS rollout<\/li>\n<li data-section-id=\"177m0ml\" data-start=\"1119\" data-end=\"1206\">Execution of global QMS training sessions for relevant departments and stakeholders<\/li>\n<\/ul>\n<h2 data-section-id=\"8o5wxu\" data-start=\"1213\" data-end=\"1233\">Project Execution<\/h2>\n<p data-start=\"1235\" data-end=\"1404\">In the initial phase, the existing <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> systems within the organization were analyzed and evaluated against regulatory requirements and industry standards.<\/p>\n<p data-start=\"1406\" data-end=\"1482\">Subsequently, a new QMS concept was developed, covering the following areas:<\/p>\n<ul>\n<li data-section-id=\"14xe03l\" data-start=\"1484\" data-end=\"1502\">Infrastructure\n<ul>\n<li data-section-id=\"gg9kth\" data-start=\"1503\" data-end=\"1525\">IT Risk Management<\/li>\n<li data-section-id=\"r6y7vb\" data-start=\"1526\" data-end=\"1563\">IT Asset and Inventory Management<\/li>\n<li data-section-id=\"3bhcp4\" data-start=\"1564\" data-end=\"1602\">Monitoring and Capacity Management<\/li>\n<li data-section-id=\"1kffsk5\" data-start=\"1603\" data-end=\"1643\"><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> Centre \/ Server Room Management<\/li>\n<li data-section-id=\"1fu5mny\" data-start=\"1644\" data-end=\"1676\">Infrastructure Qualification<\/li>\n<li data-section-id=\"1jng61i\" data-start=\"1677\" data-end=\"1710\">Backup and Restore Management<\/li>\n<li data-section-id=\"1sc6rdk\" data-start=\"1711\" data-end=\"1742\">Change and Patch Management<\/li>\n<li data-section-id=\"yqba3b\" data-start=\"1743\" data-end=\"1773\">Service Request Management<\/li>\n<li data-section-id=\"7o8gl3\" data-start=\"1774\" data-end=\"1805\">(Major) Incident Management<\/li>\n<li data-section-id=\"3d2rio\" data-start=\"1806\" data-end=\"1828\">Problem Management<\/li>\n<\/ul>\n<\/li>\n<li data-section-id=\"1xdhp3u\" data-start=\"1830\" data-end=\"1854\">Software Development\n<ul>\n<li data-section-id=\"1owxedl\" data-start=\"1855\" data-end=\"1888\">Software Development Planning<\/li>\n<li data-section-id=\"q1wiid\" data-start=\"1889\" data-end=\"1934\">Software Requirements and Risk Assessment<\/li>\n<li data-section-id=\"1jokj1n\" data-start=\"1935\" data-end=\"1971\">Software Design and Architecture<\/li>\n<li data-section-id=\"12la75g\" data-start=\"1972\" data-end=\"1996\">Software Development<\/li>\n<li data-section-id=\"16e2yw5\" data-start=\"1997\" data-end=\"2027\">Software <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> Assurance<\/li>\n<li data-section-id=\"rtm3y0\" data-start=\"2028\" data-end=\"2064\">Software Release and Maintenance<\/li>\n<\/ul>\n<\/li>\n<li data-section-id=\"zj1ra5\" data-start=\"2066\" data-end=\"2100\"><a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a>\n<ul>\n<li data-start=\"2102\" data-end=\"2120\">Project Phase\n<ul>\n<li data-section-id=\"1uxk7q2\" data-start=\"2121\" data-end=\"2179\">Validation and Implementation of GxP-regulated systems<\/li>\n<li data-section-id=\"lyao2i\" data-start=\"2180\" data-end=\"2223\">Implementation of non-regulated systems<\/li>\n<\/ul>\n<\/li>\n<li data-start=\"2225\" data-end=\"2247\">Operational Phase<\/li>\n<li data-start=\"2249\" data-end=\"2270\">Retirement Phase<\/li>\n<li data-section-id=\"1spc110\" data-start=\"2271\" data-end=\"2289\"><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> Migration<\/li>\n<li data-section-id=\"279nzz\" data-start=\"2290\" data-end=\"2308\"><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> Archiving<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p data-start=\"2310\" data-end=\"2440\">As part of the implementation, all necessary policies, directives, SOPs, work instructions, and document templates were developed. Additionally, Training materials were created for all relevant areas and Training sessions were planned and conducted for the respective employee groups and departments.<\/p>\n<h2 data-section-id=\"1prirdc\" data-start=\"2621\" data-end=\"2644\">Results and Benefits<\/h2>\n<p data-start=\"0\" data-end=\"367\">The project was successfully completed on time and within the planned budget. This was achieved through appropriate scaling of the analysis, development, and rollout activities, which were efficiently aligned and executed in a resource-efficient manner. As a result, potential bottlenecks were identified early and avoided, ensuring a smooth overall project timeline.<\/p>\n<p data-start=\"369\" data-end=\"701\">The implemented global QMS significantly improved both efficiency and compliance. The globally harmonized processes and approaches ensured consistent compliance with regulatory requirements across the entire organization. <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> efficiency was substantially increased, and a unified global understanding of <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> was established.<\/p>\n<p data-start=\"703\" data-end=\"889\" data-is-last-node=\"\" data-is-only-node=\"\">The QMS approach and related documentation were reviewed by the company&rsquo;s internal <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> assurance function, and any identified inconsistencies were promptly resolved prior to rollout.<\/p>\n<p data-start=\"703\" data-end=\"889\" data-is-last-node=\"\" data-is-only-node=\"\">For more information about <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>&rsquo;s case studies check out our <a href=\"https:\/\/q-finity.de\/en\/\">Project News<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This case study focuses on the design and implementation of a global QMS concept for an international pharmaceutical company. Problem Statement The client is an internationally operating company in the field of pharmaceutical active ingredient research. Its services include the research and development of new pharmaceutical compounds as well as the development of software platforms [&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-14470","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>Global QMS Concept Case Study<\/title>\n<meta name=\"description\" content=\"This case study focuses on the design and implementation of a global QMS concept for an international pharmaceutical company.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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