{"id":13617,"date":"2025-01-10T12:00:57","date_gmt":"2025-01-10T11:00:57","guid":{"rendered":"https:\/\/q-finity.de\/?p=13617"},"modified":"2025-01-10T12:00:57","modified_gmt":"2025-01-10T11:00:57","slug":"creation-of-a-global-quality-management-system","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/creation-of-a-global-quality-management-system\/","title":{"rendered":"Creation of a global quality management system"},"content":{"rendered":"<h2>The project<\/h2>\n<p>This project involved the creation of a 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.<\/p>\n<p><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 a global service provider, which had grown significantly through acquisitions, in the harmonization and global implementation of a uniform <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 for all areas of IT and <a href=\"https:\/\/q-finity.de\/en\/glossar\/computer\/\" target=\"_self\" title=\"A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention. If you need more information please contact us here.\" class=\"encyclopedia\">computer<\/a> systems.<\/p>\n<p>This included processes and services in the areas of infrastructure management, software development and the implementation of computerized systems. As the service provider has products and services in all GXP areas in its portfolio, an approach had to be found that satisfactorily supports all relevant regulations. Furthermore, the <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 had to be based on standards such as GAMP 5 and ITIL. <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 creation of the QMS concept as well as the design and documentation of the individual processes within the QMS. <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> also supported the global implementation with training materials, workshops and individual consulting services for individual areas.<\/p>\n<h2>The goal<\/h2>\n<p>The overall objective of the project was the development, harmonization and worldwide implementation of a comprehensive and uniform <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). This system was to be designed to cover all areas of IT and the <a href=\"https:\/\/q-finity.de\/en\/glossar\/computer\/\" target=\"_self\" title=\"A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention. If you need more information please contact us here.\" class=\"encyclopedia\">computer<\/a> systems used throughout the company. This measure was intended to ensure that the same <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 were applied worldwide. It was important to ensure that all departments and locations benefit from the consistent and optimized processes. The QMS should create a basis that makes it possible to standardize <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> processes. It should also increase efficiency within the IT structure and at the same time ensure operational reliability and stability in all technical processes.<\/p>\n<p>A particular focus was on the development of a flexible QMS that could be adapted to the specific requirements of different IT areas. Care had to be taken to ensure that global standards and regulatory requirements were not compromised in the <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>. Central harmonization increases the transparency of processes and guidelines, which supports the company&rsquo;s continuous improvement <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>. All employees, regardless of location or specific IT department, should be enabled to use the system efficiently and correctly through training and clear instructions.<\/p>\n<p>In addition to increasing efficiency and compliance with global <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, the project is designed to minimize the risks that could arise from country-specific deviations in the IT infrastructure. The new QMS thus serves as a global reference framework that ensures that a high level 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>, security and consistency is achieved in all company processes. This enables the company to react more agilely to regulatory and technological changes.<\/p>\n<h2>Any questions about creating a global QMS?<\/h2>\n<p>What are the critical success factors when implementing a global QMS?<\/p>\n<ul>\n<li>The following factors are of particular importance when implementing a global QMS:<\/li>\n<li>Support from all relevant stakeholders, especially management: successful implementation is only possible if it is clear to everyone involved that the implementation is being carried out on behalf of and with the support of management. In this context, the reasons and necessities for implementing a harmonized <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 HS must also be clearly communicated to everyone. The reasons and necessities may include\n<ul>\n<li>To ensure regulatory compliance<\/li>\n<li>to fulfill customer expectations<\/li>\n<li>and thus ensure the long-term success of the company.<\/li>\n<\/ul>\n<\/li>\n<li>Training and consulting for all affected areas: The creation and implementation of the relevant standard operating procedures is only a first step for the implementation of a <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 HS. The relevant departments and their employees must be comprehensively trained in the new processes and the underlying requirements. For relevant areas, it may be necessary to provide individual consulting services, for example to ensure initial compliance for complex and critical systems.<\/li>\n<\/ul>\n<p>What initial obstacles do you have to expect in a project like this?<\/p>\n<ul>\n<li>One initial obstacle is the different terminology that is established in individual areas. The creation of a universally recognized glossary helps to overcome difficulties in understanding and terminology problems.<br>\nFurthermore, it is advisable to analyse 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> processes and find a balanced &ldquo;best of breed&rdquo; approach that takes up processes already established in parts of the company, harmonizes them and then rolls them out throughout the entire company. This increases the general acceptance among the employees in the company as they recognize at least parts of their familiar processes.<\/li>\n<\/ul>\n<p>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","protected":false},"excerpt":{"rendered":"<p>The project This project involved the creation of a global quality management system. QFINITY supported a global service provider, which had grown significantly through acquisitions, in the harmonization and global implementation of a uniform quality management system for all areas of IT and computer systems. This included processes and services in the areas of infrastructure [&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-13617","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>Quality Management System with QFINITY<\/title>\n<meta name=\"description\" content=\"In this project, a global service provider was supported by QFINITY in the creation of a global Quality Management System.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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