{"id":14470,"date":"2026-04-08T14:22:46","date_gmt":"2026-04-08T12:22:46","guid":{"rendered":"https:\/\/q-finity.de\/?p=14470"},"modified":"2026-07-07T14:48:41","modified_gmt":"2026-07-07T12:48:41","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 class=\"qf-abstract\">Grown through acquisitions, an international pharmaceutical company needed a harmonized global QMS. QFINITY designed and implemented it along <a href=\"https:\/\/q-finity.de\/en\/glossar\/gamp-5-begriff\/\" target=\"_self\" title=\"GAMP 5 - &quot;A Risk-Based Approach to Compliant GxP Computerized Systems&quot; - is ISPE's industry guide to the validation of computerized systems: published in 2008, and available since 2022 in the Second Edition, which strengthens critical thinking and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements - GAMP shows a&hellip;\" class=\"encyclopedia\">GAMP 5<\/a> and ITIL &ndash; across infrastructure, software development, and computerized system validation &ndash; including a training concept and a worldwide rollout.<\/p>\n<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 international company in pharmaceutical active ingredient research. Its services range from researching and developing new pharmaceutical compounds to building software platforms for specialized methods in this domain.<\/p>\n<p data-start=\"304\" data-end=\"498\">After years of significant growth through acquisitions, the company needed to consolidate its various quality management 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.\" 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 Infrastructure, Software Development, and <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, QFINITY analyzed the organization&rsquo;s existing quality management systems and evaluated them against regulatory requirements and industry standards.<\/p>\n<p data-start=\"1406\" data-end=\"1482\">QFINITY then developed a new QMS concept 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.\" class=\"encyclopedia\">Data<\/a> Centre \/ Server Room Management<\/li>\n<li data-section-id=\"1fu5mny\" data-start=\"1644\" data-end=\"1676\">Infrastructure <a href=\"https:\/\/q-finity.de\/en\/glossar\/qualification\/\" target=\"_self\" title=\"Qualification is the act of demonstration for the stable, stationary object - plant, equipment, and piping in GMP manufacturing, and likewise the IT infrastructure (frame of reference: EU GMP Annex 15; Annex 11, principle: validate the application, qualify the IT infrastructure). A state once qualified remains reliable under controlled conditions - the most stable object&hellip;\" class=\"encyclopedia\">Qualification<\/a><\/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 \"qualitas\", which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent characteristics of an object meets requirements. Inherent means \"intrinsic to a particular unit\".' 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\/\" target=\"_self\" title=\"The term computerized system covers a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components,&hellip;\" class=\"encyclopedia\">Computerized System<\/a> Validation\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\">Data Migration<\/li>\n<li data-section-id=\"279nzz\" data-start=\"2290\" data-end=\"2308\">Data Archiving<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p data-start=\"2310\" data-end=\"2440\">As part of the implementation, QFINITY developed all necessary policies, directives, SOPs, work instructions, and document templates. It also created training materials for all relevant areas and planned and ran training sessions for the respective employee groups and departments.<\/p>\n<blockquote class=\"qf-pullquote\">\n<p>A global QMS thrives not on the rule book but on a shared understanding of quality across every site.<\/p>\n<\/blockquote>\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 completed successfully on time and within the planned budget. Appropriately scaling the analysis, development, and rollout activities &ndash; and coordinating them efficiently &ndash; made this possible. Potential bottlenecks were identified early and avoided, keeping the overall project timeline on track.<\/p>\n<p data-start=\"369\" data-end=\"701\">The implemented global QMS significantly improved both efficiency and compliance. 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=\"A process is a set of interrelated or interacting activities which transform inputs into outputs.\" class=\"encyclopedia\">Process<\/a> efficiency increased substantially, and the company established a unified global understanding of quality.<\/p>\n<p data-start=\"703\" data-end=\"889\" data-is-last-node=\"\" data-is-only-node=\"\">The company&rsquo;s internal quality assurance function reviewed the QMS approach and related documentation, and any inconsistencies identified were resolved promptly before rollout.<\/p>\n<p data-start=\"703\" data-end=\"889\" data-is-last-node=\"\" data-is-only-node=\"\">For more information about QFINITY&rsquo;s case studies, check out our <a href=\"https:\/\/q-finity.de\/en\/\">Project News<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Grown through acquisitions, an international pharmaceutical company needed a harmonized global QMS. QFINITY designed and implemented it along GAMP 5 and ITIL &#8211; across infrastructure, software development, and computerized system validation &#8211; including a training concept and a worldwide rollout. This case study focuses on the design and implementation of a global QMS concept for [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":15447,"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","has-post-thumbnail","hentry","category-project-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Global QMS Concept for a Pharma Company | QFINITY<\/title>\n<meta name=\"description\" content=\"QFINITY designed a global QMS concept for an international pharmaceutical company - harmonized to GAMP 5 &amp; ITIL, including CSV and a worldwide rollout.\" \/>\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\/global-qms-concept-case-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Global QMS Concept for a Pharma Company | QFINITY\" \/>\n<meta property=\"og:description\" content=\"QFINITY designed a global QMS concept for an international pharmaceutical company - harmonized to GAMP 5 &amp; 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