{"id":14481,"date":"2026-04-08T15:08:16","date_gmt":"2026-04-08T13:08:16","guid":{"rendered":"https:\/\/q-finity.de\/?p=14481"},"modified":"2026-04-08T15:08:16","modified_gmt":"2026-04-08T13:08:16","slug":"it-quality-management","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/it-quality-management\/","title":{"rendered":"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments"},"content":{"rendered":"<p data-start=\"0\" data-end=\"224\">In this case study, the focus is on the restoration of IT systems following a ransomware attack. It also considers ensuring compliance and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a> through targeted IT <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> in a GxP-regulated environment.<\/p>\n<h2 data-start=\"0\" data-end=\"224\">Problem statement<\/h2>\n<p data-start=\"226\" data-end=\"886\">The client is an internationally operating company in the field of pharmaceutical active ingredient research. Its services include the research and development of new active ingredients. They also include the development of software platforms for specialized methods in this environment. The company became the target of a ransomware attack in which large parts of the existing infrastructure, systems, and <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> were encrypted and thus made inaccessible. As some of these <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> and systems were GxP-relevant, the restoration of IT services and functions had to be closely accompanied. Furthermore, it had to be fully documented from an IT <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> 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 <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><\/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. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a> Privacy, and IT Operations<\/li>\n<li data-start=\"939\" data-end=\"1358\">Creation 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> 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 <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 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 beginning of the project, the recovery activities defined by the project team were recorded and evaluated with regard to their regulatory relevance. In addition, the results of the forensic analysis of the ransomware attack were incorporated in order to review the effectiveness of 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 optimize them where necessary. Based on this analysis, a <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> plan was developed covering the following activities and areas:<\/p>\n<ul>\n<li data-start=\"1843\" data-end=\"2754\">Development of a procedural recovery framework through the <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 forensic findings and 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> framework<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Restoration of a secure IT infrastructure through the establishment of a secure environment<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Creation of regulatory documentation through complete documentation of the restored IT infrastructure for compliance requirements<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Reinstallation of IT systems by means of recovery through new installations to eliminate malicious code<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Integrity-assured <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 through documented transfer of relevant <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> while maintaining consistency<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Consolidation of <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> sets through synchronization of restored <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> 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 <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> prior to release<\/li>\n<li data-start=\"1843\" data-end=\"2754\">Timely <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> reporting and release management for efficient approval of infrastructure and systems<\/li>\n<\/ul>\n<p class=\"yoast-text-mark\">The implementation of this plan and the associated activities required intensive coordination with all departments. This was necessary in order to enable a fast, secure, and regulatorily compliant release of IT services and systems.<\/p>\n<h2 data-start=\"2972\" data-end=\"3674\">Results and benefits<\/h2>\n<p class=\"yoast-text-mark\" data-start=\"2972\">The project was successfully completed on schedule and within the planned budget, as analysis, documentation, and release activities were appropriately scaled and efficiently coordinated. The restored IT systems and associated <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> fully meet all internal and regulatory requirements. Throughout the entire recovery <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>, 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 continuously monitored the created documentation in close coordination with the IT <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> function to ensure complete regulatory compliance and adherence to the highest 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> standards. The resulting IT infrastructure meets the highest requirements in terms of security, <a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>, and operational reliability.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In this case study, the focus is on the restoration of IT systems following a ransomware attack. It also considers ensuring compliance and data integrity through targeted IT quality management in a GxP-regulated environment. Problem statement The client is an internationally operating company in the field of pharmaceutical active ingredient research. Its services include the [&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-14481","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>IT Quality Management Case Study<\/title>\n<meta name=\"description\" content=\"In this case study of QFINITY, the focus is on the restoration of IT systems following a ransomware attack.\" \/>\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\/it-quality-management\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\" \/>\n<meta property=\"og:description\" content=\"In this case study of QFINITY, the focus is on the restoration of IT systems following a ransomware attack.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/it-quality-management\/\" \/>\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=\"2026-04-08T13:08:16+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\/it-quality-management\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/it-quality-management\/\"},\"author\":{\"name\":\"Maike Henrichmann\",\"@id\":\"https:\/\/q-finity.de\/en\/#\/schema\/person\/9f304da5294d2d15c3f03d2521c47921\"},\"headline\":\"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\",\"datePublished\":\"2026-04-08T13:08:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/q-finity.de\/en\/it-quality-management\/\"},\"wordCount\":527,\"publisher\":{\"@id\":\"https:\/\/q-finity.de\/en\/#organization\"},\"articleSection\":[\"Project News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/it-quality-management\/\",\"url\":\"https:\/\/q-finity.de\/en\/it-quality-management\/\",\"name\":\"IT Quality Management Case Study\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2026-04-08T13:08:16+00:00\",\"description\":\"In this case study of QFINITY, the focus is on the restoration of IT systems following a ransomware attack.\",\"breadcrumb\":{\"@id\":\"https:\/\/q-finity.de\/en\/it-quality-management\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/q-finity.de\/en\/it-quality-management\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/q-finity.de\/en\/it-quality-management\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/q-finity.de\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\"}]},{\"@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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