{"id":15119,"date":"2026-06-18T09:34:56","date_gmt":"2026-06-18T07:34:56","guid":{"rendered":"https:\/\/q-finity.de\/projects\/"},"modified":"2026-07-06T22:46:57","modified_gmt":"2026-07-06T20:46:57","slug":"projects","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/projects\/","title":{"rendered":"Project News"},"content":{"rendered":"\n<div  class='av-alb-blogposts template-blog  av-blog-meta-author-disabled av-blog-meta-comments-disabled av-blog-meta-category-disabled av-blog-meta-date-disabled av-blog-meta-tag-disabled '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Blog\" ><article class=\"post-entry post-entry-type-standard post-entry-14507 post-loop-1 post-parity-odd single-big with-slider post-14507 post type-post status-publish format-standard has-post-thumbnail hentry category-project-news\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" ><div class=\"blog-meta\"><\/div><div class='entry-content-wrapper clearfix standard-content'><header class=\"entry-content-header\" aria-label=\"Post: Enabling GxP-Compliant Cloud Services through Global QMS Enhancement\"><div class=\"av-heading-wrapper\"><span class=\"blog-categories minor-meta\"><a href=\"https:\/\/q-finity.de\/en\/kategorie\/project-news\/\" rel=\"tag\">Project News<\/a><\/span><h2 class='post-title entry-title '  itemprop=\"headline\" ><a href=\"https:\/\/q-finity.de\/en\/cloud-services\/\" rel=\"bookmark\" title=\"Permanent Link: Enabling GxP-Compliant Cloud Services through Global QMS Enhancement\">Enabling GxP-Compliant Cloud Services through Global QMS Enhancement<span class=\"post-format-icon minor-meta\"><\/span><\/a><\/h2><\/div><\/header><span class=\"av-vertical-delimiter\"><\/span><div class=\"big-preview single-big\"  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><a href=\"https:\/\/q-finity.de\/en\/cloud-services\/\"  title=\"projekt-cloud-nutzung-card\" ><img data-opt-id=683342882  fetchpriority=\"high\" decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"423\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1024\/h:423\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekt-cloud-nutzung-card.png\" class=\"wp-image-15445 avia-img-lazy-loading-15445 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"GxP-konforme Cloud-Nutzung - QFINITY\" \/><\/a><\/div><div class=\"entry-content\"  itemprop=\"text\" ><p class=\"qf-abstract\">A CDMO wanted to use cloud services &ndash; including hosting GxP-relevant systems. QFINITY evolved the global quality management system so that Infrastructure as a Service, Infrastructure as Code, and cloud operation and monitoring are covered in a fully GxP-compliant way &ndash; on time and on budget.<\/p>\n<h2 data-section-id=\"1ehl6qz\" data-start=\"142\" data-end=\"162\">Problem Statement<\/h2>\n<p data-start=\"164\" data-end=\"541\">The customer is an international contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Its services span comprehensive product development, from the early research phase through commercial-scale production. It also manufactures active pharmaceutical ingredients and finished medicinal products.<\/p>\n<p>The company plans to expand its use of cloud services, particularly for infrastructure (IaC), and later use them to host GxP-relevant systems. To achieve this, the customer needed:<\/p>\n<ul>\n<li data-start=\"543\" data-end=\"770\">Analysis of the global quality management system&rsquo;s suitability for managing cloud services across infrastructure, Infrastructure as Code (IaC), and system deployment and operation<\/li>\n<li data-start=\"543\" data-end=\"770\">Identification and assessment of potential gaps in the existing process framework, and development of practical, regulatory-compliant solutions for cloud environments<\/li>\n<li data-start=\"543\" data-end=\"770\">Creation and revision of policies, directives, SOPs, work instructions, and the required templates for infrastructure and computerized system validation to ensure a consistent and auditable approach<\/li>\n<\/ul>\n<h2 data-section-id=\"8o5wxu\" data-start=\"1374\" data-end=\"1394\">Project Execution<\/h2>\n<p data-start=\"1396\" data-end=\"1931\">In the first phase, QFINITY analyzed the company&rsquo;s existing quality management system for its suitability for cloud services and evaluated it against regulatory requirements and relevant industry standards. QFINITY then developed concrete change proposals for the affected processes and aligned them with the responsible departments. The customer approved the finalized documents in accordance with its own processes and implemented them within the company.<\/p>\n<blockquote class=\"qf-pullquote\">\n<p>Cloud becomes GxP-compliant when the quality management system carries it &ndash; not the technology alone.<\/p>\n<\/blockquote>\n<h2 data-section-id=\"1prirdc\" data-start=\"1933\" data-end=\"1956\">Results and Benefits<\/h2>\n<p data-start=\"1958\" data-end=\"2144\">The project was completed successfully, on schedule and within the planned budget. This was possible because the analysis, creation, and approval activities were properly planned and precisely coordinated.<\/p>\n<p data-start=\"2146\" data-end=\"2750\" data-is-last-node=\"\" data-is-only-node=\"\">The revised processes of the global quality management system provide a clear, regulatory-compliant framework for the use of cloud services. In particular, they cover Infrastructure as a Service (IaaS), Infrastructure as Code (IaC), and the deployment and operation of computerized systems in cloud environments. They also define consistent requirements for planning, qualification, change and release management, monitoring, and incident and problem management in cloud contexts. These requirements ensure that all activities are documented consistently in a GxP-compliant manner.<\/p>\n<\/div><span class=\"post-meta-infos\"><\/span><footer class=\"entry-footer\"><\/footer><div class='post_delimiter'><\/div><\/div><div class=\"post_author_timeline\"><\/div><span class='hidden'>\n\t\t\t\t<span class='av-structured-data'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" >\n\t\t\t\t\t\t<span itemprop='url'>https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekt-cloud-nutzung-card.png<\/span>\n\t\t\t\t\t\t<span itemprop='height'>576<\/span>\n\t\t\t\t\t\t<span itemprop='width'>1024<\/span>\n\t\t\t\t<\/span>\n\t\t\t\t<span class='av-structured-data'  itemprop=\"publisher\" itemtype=\"https:\/\/schema.org\/Organization\" itemscope=\"itemscope\" >\n\t\t\t\t\t\t<span itemprop='name'>Maike Henrichmann<\/span>\n\t\t\t\t\t\t<span itemprop='logo' itemscope itemtype='https:\/\/schema.org\/ImageObject'>\n\t\t\t\t\t\t\t<span itemprop='url'>https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/q-finity_schriftzug_orange-retina.png<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t\t\t<\/span><span class='av-structured-data'  itemprop=\"author\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Person\" ><span itemprop='name'>Maike Henrichmann<\/span><\/span><span class='av-structured-data'  itemprop=\"datePublished\" datetime=\"2026-04-26T10:49:03+02:00\" >2026-04-26 10:49:03<\/span><span class='av-structured-data'  itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\" >2026-07-07 14:49:12<\/span><span class='av-structured-data'  itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\" ><span itemprop='name'>Enabling GxP-Compliant Cloud Services through Global QMS Enhancement<\/span><\/span><\/span><\/article><article class=\"post-entry post-entry-type-standard post-entry-14481 post-loop-2 post-parity-even single-big with-slider post-14481 post type-post status-publish format-standard has-post-thumbnail hentry category-project-news\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" ><div class=\"blog-meta\"><\/div><div class='entry-content-wrapper clearfix standard-content'><header class=\"entry-content-header\" aria-label=\"Post: IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\"><div class=\"av-heading-wrapper\"><span class=\"blog-categories minor-meta\"><a href=\"https:\/\/q-finity.de\/en\/kategorie\/project-news\/\" rel=\"tag\">Project News<\/a><\/span><h2 class='post-title entry-title '  itemprop=\"headline\" ><a href=\"https:\/\/q-finity.de\/en\/it-quality-management\/\" rel=\"bookmark\" title=\"Permanent Link: IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\">IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments<span class=\"post-format-icon minor-meta\"><\/span><\/a><\/h2><\/div><\/header><span class=\"av-vertical-delimiter\"><\/span><div class=\"big-preview single-big\"  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><a href=\"https:\/\/q-finity.de\/en\/it-quality-management\/\"  title=\"projekt-it-qualitaetsmanagement-card\" ><img data-opt-id=1969664677  fetchpriority=\"high\" decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"423\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1024\/h:423\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekt-it-qualitaetsmanagement-card.png\" class=\"wp-image-15446 avia-img-lazy-loading-15446 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"IT-Qualitaetsmanagement und sichere Systemwiederherstellung - QFINITY\" \/><\/a><\/div><div class=\"entry-content\"  itemprop=\"text\" ><p class=\"qf-abstract\">After a ransomware attack, a drug-discovery company had to recover GxP-relevant systems and data &ndash; fully documented. QFINITY guided the recovery from an IT quality management perspective: from forensically grounded quality planning through integrity-assured data migration to validated release.<\/p>\n<h2 data-start=\"0\" data-end=\"224\">Problem statement<\/h2>\n<p data-start=\"226\" data-end=\"886\">The client is an international company in pharmaceutical active ingredient research. Its services include researching and developing new active ingredients and building software platforms for specialized methods in this environment. The company became the target of a ransomware attack that encrypted large parts of its infrastructure, systems, and data, making them inaccessible. Because some of these data and systems were GxP-relevant, the restoration of IT services and functions had to be closely overseen &ndash; and fully documented from an IT quality management perspective.<\/p>\n<p data-start=\"888\" data-end=\"937\">To achieve this objective, the client required:<\/p>\n<ul>\n<li data-start=\"939\" data-end=\"1358\">Support in documenting and evaluating recovery activities for infrastructure, IT systems, and data<\/li>\n<li data-start=\"939\" data-end=\"1358\">Coordination of activities with other departments, e.g. IT Security, <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> Privacy, and IT Operations<\/li>\n<li data-start=\"939\" data-end=\"1358\">Creation of quality reports for individual sub-areas of restored IT services and functionalities<\/li>\n<li data-start=\"939\" data-end=\"1358\">Review and, if necessary, improvement of existing quality management processes to prevent future IT security risks<\/li>\n<\/ul>\n<h2 data-start=\"1360\" data-end=\"1841\">Project execution<\/h2>\n<p class=\"yoast-text-mark\">At the start of the project, QFINITY recorded the recovery activities defined by the project team and evaluated their regulatory relevance. The results of the forensic analysis of the ransomware attack fed into this work, serving to review the effectiveness of existing quality management processes and optimize them where necessary. Based on this analysis, QFINITY developed a quality plan covering the following activities and areas:<\/p>\n<ul>\n<li data-start=\"1843\" data-end=\"2754\">Development of a procedural recovery framework by integrating forensic findings with the existing quality management framework<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Restoration of a secure IT infrastructure by establishing a secure environment<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Creation of regulatory documentation by fully documenting the restored IT infrastructure for compliance requirements<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Reinstallation of IT systems as clean new installations to eliminate malicious code<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Integrity-assured data migration through documented transfer of relevant data while maintaining consistency<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Consolidation of data sets by synchronizing restored data with information newly generated since the attack<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Comprehensive system validation through documented testing of restored systems and data prior to release<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Timely quality reporting and release management for efficient approval of infrastructure and systems<\/li>\n<\/ul>\n<p class=\"yoast-text-mark\">Implementing this plan and the associated activities required intensive coordination with all departments to enable a fast, secure release of IT services and systems in full regulatory compliance.<\/p>\n<blockquote class=\"qf-pullquote\">\n<p>In recovery, what matters is not speed but the complete traceability of every recovery activity.<\/p>\n<\/blockquote>\n<h2 data-start=\"2972\" data-end=\"3674\">Results and benefits<\/h2>\n<p class=\"yoast-text-mark\" data-start=\"2972\">The project was completed successfully on schedule and within the planned budget because analysis, documentation, and release activities were appropriately scaled and efficiently coordinated. The restored IT systems and associated data fully meet all internal and regulatory requirements. Throughout the recovery, internal quality assurance continuously monitored the documentation in close coordination with the IT quality function, ensuring complete regulatory compliance and adherence to the highest internal quality standards. The resulting IT infrastructure meets the most stringent requirements for security, data integrity, and operational reliability.<\/p>\n<\/div><span class=\"post-meta-infos\"><\/span><footer class=\"entry-footer\"><\/footer><div class='post_delimiter'><\/div><\/div><div class=\"post_author_timeline\"><\/div><span class='hidden'>\n\t\t\t\t<span class='av-structured-data'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" >\n\t\t\t\t\t\t<span itemprop='url'>https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekt-it-qualitaetsmanagement-card.png<\/span>\n\t\t\t\t\t\t<span itemprop='height'>576<\/span>\n\t\t\t\t\t\t<span itemprop='width'>1024<\/span>\n\t\t\t\t<\/span>\n\t\t\t\t<span class='av-structured-data'  itemprop=\"publisher\" itemtype=\"https:\/\/schema.org\/Organization\" itemscope=\"itemscope\" >\n\t\t\t\t\t\t<span itemprop='name'>Maike Henrichmann<\/span>\n\t\t\t\t\t\t<span itemprop='logo' itemscope itemtype='https:\/\/schema.org\/ImageObject'>\n\t\t\t\t\t\t\t<span itemprop='url'>https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/q-finity_schriftzug_orange-retina.png<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t\t\t<\/span><span class='av-structured-data'  itemprop=\"author\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Person\" ><span itemprop='name'>Maike Henrichmann<\/span><\/span><span class='av-structured-data'  itemprop=\"datePublished\" datetime=\"2026-04-08T15:08:16+02:00\" >2026-04-08 15:08:16<\/span><span class='av-structured-data'  itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\" >2026-07-07 14:48:43<\/span><span class='av-structured-data'  itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\" ><span itemprop='name'>IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments<\/span><\/span><\/span><\/article><article class=\"post-entry post-entry-type-standard post-entry-14470 post-loop-3 post-parity-odd post-entry-last single-big with-slider post-14470 post type-post status-publish format-standard has-post-thumbnail hentry category-project-news\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" ><div class=\"blog-meta\"><\/div><div class='entry-content-wrapper clearfix standard-content'><header class=\"entry-content-header\" aria-label=\"Post: Global QMS concept for an international pharmaceutical company: design and implementation\"><div class=\"av-heading-wrapper\"><span class=\"blog-categories minor-meta\"><a href=\"https:\/\/q-finity.de\/en\/kategorie\/project-news\/\" rel=\"tag\">Project News<\/a><\/span><h2 class='post-title entry-title '  itemprop=\"headline\" ><a href=\"https:\/\/q-finity.de\/en\/global-qms-concept-case-study\/\" rel=\"bookmark\" title=\"Permanent Link: Global QMS concept for an international pharmaceutical company: design and implementation\">Global QMS concept for an international pharmaceutical company: design and implementation<span class=\"post-format-icon minor-meta\"><\/span><\/a><\/h2><\/div><\/header><span class=\"av-vertical-delimiter\"><\/span><div class=\"big-preview single-big\"  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><a href=\"https:\/\/q-finity.de\/en\/global-qms-concept-case-study\/\"  title=\"projekt-globales-qms-konzept-fallstudie-card\" ><img data-opt-id=1270567650  fetchpriority=\"high\" decoding=\"async\" loading=\"lazy\" width=\"1024\" height=\"423\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:1024\/h:423\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekt-globales-qms-konzept-fallstudie-card.png\" class=\"wp-image-15447 avia-img-lazy-loading-15447 attachment-entry_without_sidebar size-entry_without_sidebar wp-post-image\" alt=\"Globales QMS-Konzept fuer Pharma - QFINITY\" \/><\/a><\/div><div class=\"entry-content\"  itemprop=\"text\" ><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<\/div><span class=\"post-meta-infos\"><\/span><footer class=\"entry-footer\"><\/footer><div class='post_delimiter'><\/div><\/div><div class=\"post_author_timeline\"><\/div><span class='hidden'>\n\t\t\t\t<span class='av-structured-data'  itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" >\n\t\t\t\t\t\t<span itemprop='url'>https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekt-globales-qms-konzept-fallstudie-card.png<\/span>\n\t\t\t\t\t\t<span itemprop='height'>576<\/span>\n\t\t\t\t\t\t<span itemprop='width'>1024<\/span>\n\t\t\t\t<\/span>\n\t\t\t\t<span class='av-structured-data'  itemprop=\"publisher\" itemtype=\"https:\/\/schema.org\/Organization\" itemscope=\"itemscope\" >\n\t\t\t\t\t\t<span itemprop='name'>Maike Henrichmann<\/span>\n\t\t\t\t\t\t<span itemprop='logo' itemscope itemtype='https:\/\/schema.org\/ImageObject'>\n\t\t\t\t\t\t\t<span itemprop='url'>https:\/\/q-finity.de\/wp-content\/uploads\/2026\/07\/q-finity_schriftzug_orange-retina.png<\/span>\n\t\t\t\t\t\t<\/span>\n\t\t\t\t<\/span><span class='av-structured-data'  itemprop=\"author\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Person\" ><span itemprop='name'>Maike Henrichmann<\/span><\/span><span class='av-structured-data'  itemprop=\"datePublished\" datetime=\"2026-04-08T14:22:46+02:00\" >2026-04-08 14:22:46<\/span><span class='av-structured-data'  itemprop=\"dateModified\" itemtype=\"https:\/\/schema.org\/dateModified\" >2026-07-07 14:48:41<\/span><span class='av-structured-data'  itemprop=\"mainEntityOfPage\" itemtype=\"https:\/\/schema.org\/mainEntityOfPage\" ><span itemprop='name'>Global QMS concept for an international pharmaceutical company: design and implementation<\/span><\/span><\/span><\/article><div class='single-big'><nav class='pagination'><span class='pagination-meta'>Page 1 of 3<\/span><span class='current'>1<\/span><a href='https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/15119\/page\/2\/' class='inactive next_page' >2<\/a><a href='https:\/\/q-finity.de\/en\/wp-json\/wp\/v2\/pages\/15119\/page\/3\/' class='inactive' >3<\/a><\/nav>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"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.&hellip;","protected":false},"author":5,"featured_media":15295,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-15119","page","type-page","status-publish","has-post-thumbnail","hentry"],"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>Projects: GxP Project Work | QFINITY<\/title>\n<meta name=\"description\" content=\"Insight into projects QFINITY delivers for its clients - completed engagements from the GxP-regulated environment in pharma and medtech.\" \/>\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\/projects\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Projects: GxP Project Work | QFINITY\" \/>\n<meta property=\"og:description\" content=\"Insight into projects QFINITY delivers for its clients - completed engagements from the GxP-regulated environment in pharma and medtech.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/projects\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-06T20:46:57+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2026\/06\/projekte-01-hero.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"576\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"Project News\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/\",\"name\":\"Projects: GxP Project Work | QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/06\\/projekte-01-hero.png\",\"datePublished\":\"2026-06-18T07:34:56+00:00\",\"dateModified\":\"2026-07-06T20:46:57+00:00\",\"description\":\"Insight into projects QFINITY delivers for its clients - completed engagements from the GxP-regulated environment in pharma and medtech.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/#primaryimage\",\"url\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/06\\/projekte-01-hero.png\",\"contentUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2026\\/06\\/projekte-01-hero.png\",\"width\":1024,\"height\":576,\"caption\":\"GxP projects - QFINITY\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/projects\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/q-finity.de\\\/en\\\/home\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Project News\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; 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