{"id":4900,"date":"2021-03-02T14:59:06","date_gmt":"2021-03-02T13:59:06","guid":{"rendered":"https:\/\/q-finity.de\/bereiche\/validierung-computergestuetzter-systeme\/"},"modified":"2024-04-03T13:05:59","modified_gmt":"2024-04-03T11:05:59","slug":"validation-of-computerized-systems","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/service-areas\/validation-of-computerized-systems\/","title":{"rendered":"Validation of Computerized Systems"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1315fn4-f34c15a8170376ca4d473b65369ac2f7\">\n.avia-section.av-1315fn4-f34c15a8170376ca4d473b65369ac2f7{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/hero_company_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n#top .avia-section.av-1315fn4-f34c15a8170376ca4d473b65369ac2f7 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-1315fn4-f34c15a8170376ca4d473b65369ac2f7 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_1\" class=\"avia-section av-1315fn4-f34c15a8170376ca4d473b65369ac2f7 alternate_color avia-section-large avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-contain avia-bg-style-scroll av-minimum-height av-minimum-height-50 av-height-50  container_wrap fullsize\" data-section-bg-repeat=\"contain\" data-av_minimum_height_pc=\"50\" data-av_min_height_opt=\"50\"><div class=\"av-section-color-overlay-wrap\"><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-1\" aria-describedby=\"av-svg-desc-1\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-1\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-1\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><main role=\"main\" itemprop=\"mainContentOfPage\" class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4900\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178\">\n#top .av-special-heading.av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-kls2svp4-9f39ff99bc6f25ebdf80472e7a838178 av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-1  avia-builder-el-no-sibling  shadoworange av-inherit-size\"><h1 class=\"av-special-heading-tag \" itemprop=\"headline\"><span class=\"firstheading\">Validation of Computerized Systems<\/span><\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-10jzzio-a1b8291a6c78008d6e7a194d8a98a05b\">\n.avia-section.av-10jzzio-a1b8291a6c78008d6e7a194d8a98a05b .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-10jzzio-a1b8291a6c78008d6e7a194d8a98a05b .scroll-down-link{\ncolor:#ea5b0c;\n}\n#top .avia-section.av-10jzzio-a1b8291a6c78008d6e7a194d8a98a05b .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ea5b0c;\nfill:#ea5b0c;\n}\n<\/style>\n<div id=\"av_section_2\" class=\"avia-section av-10jzzio-a1b8291a6c78008d6e7a194d8a98a05b main_color avia-section-default avia-no-border-styling  avia-builder-el-2  el_after_av_section  el_before_av_section  avia-bg-style-parallax av-section-color-overlay-active container_wrap fullsize\"><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-2\" aria-describedby=\"av-svg-desc-2\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-2\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-2\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4900\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-3l1krk-d63b99c1e1affc1402f42a766cac5f11 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3l1krk-d63b99c1e1affc1402f42a766cac5f11\">\n.flex_column.av-3l1krk-d63b99c1e1affc1402f42a766cac5f11{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-3l1krk-d63b99c1e1affc1402f42a766cac5f11 av_one_half  avia-builder-el-3  el_before_av_one_half  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kls2tash-97251ae773fa4bae564c2bf1944f7a97\">\n#top .av-special-heading.av-kls2tash-97251ae773fa4bae564c2bf1944f7a97{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls2tash-97251ae773fa4bae564c2bf1944f7a97 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls2tash-97251ae773fa4bae564c2bf1944f7a97 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls2tash-97251ae773fa4bae564c2bf1944f7a97 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-kls2tash-97251ae773fa4bae564c2bf1944f7a97 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-kls2tash-97251ae773fa4bae564c2bf1944f7a97 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-kls2tash-97251ae773fa4bae564c2bf1944f7a97 av-special-heading-h2 blockquote modern-quote  avia-builder-el-4  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">validation tasks<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-kl0mtsgh-b78587a0304cb920769651a9935e00a3 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>In addition to setting up&nbsp;<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 (business and IT), we take on validation tasks in part or in their entirety and thus ease your daily workload.<\/p>\n<p>Documented evidence that a system meets the previously specified <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> requirements reproducibly in operational use<\/p>\n<p>The&nbsp;processes of research, development and manufacture of chemical, pharmaceutical and medical technology products have been subject to regulation for many years. The demand for the validation of&nbsp;computerized systems (also known as IT validation), which have a direct or indirect influence on the key parameters product&nbsp;<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>, patient risk and&nbsp;<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>, was only intensified as late as 1990s with the increasing use of&nbsp;computerized systems.<\/p>\n<p>&ldquo;Where a&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is 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, together&hellip;\" class=\"encyclopedia\">computerized system<\/a>&nbsp;replaces a manual operation, there should be no resultant decrease in product&nbsp;<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>,&nbsp;<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>&nbsp;control or&nbsp;<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>&nbsp;assurance. There should be no increase in the overall risk of the&nbsp;<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>&rdquo;.&nbsp;(Excerpt EU-GMP Guideline, Annex 11)<\/p>\n<\/div><\/section><\/div><div class=\"av-flex-placeholder\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-xzwno0-6b0eebaa7cbfcc80d538ffa9cbac7af9\">\n.flex_column.av-xzwno0-6b0eebaa7cbfcc80d538ffa9cbac7af9{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-xzwno0-6b0eebaa7cbfcc80d538ffa9cbac7af9 av_one_half  avia-builder-el-6  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-w0tpr4-2b79d4da393793129aa9f7d89bf3851a\">\n.avia-image-container.av-w0tpr4-2b79d4da393793129aa9f7d89bf3851a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-w0tpr4-2b79d4da393793129aa9f7d89bf3851a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-w0tpr4-2b79d4da393793129aa9f7d89bf3851a av-styling- avia-align-center  avia-builder-el-7  avia-builder-el-no-sibling \" itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\"><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img data-opt-id=2075034042  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-5043 avia-img-lazy-loading-not-5043 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/SYSTEM-LEBENSZYKLUS_en_V.svg\" alt=\"\" title=\"SYSTEM LEBENSZYKLUS_en_V\" height=\"500\" width=\"700\" itemprop=\"thumbnailUrl\"><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-sdymzk-ea74c5cfbab9006a1319a80b9b4fd302\">\n.avia-section.av-sdymzk-ea74c5cfbab9006a1319a80b9b4fd302{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/hero_company_yellow.svg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n#top .avia-section.av-sdymzk-ea74c5cfbab9006a1319a80b9b4fd302 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-sdymzk-ea74c5cfbab9006a1319a80b9b4fd302 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_3\" class=\"avia-section av-sdymzk-ea74c5cfbab9006a1319a80b9b4fd302 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-8  el_after_av_section  el_before_av_section  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><div class=\"av-section-color-overlay-wrap\"><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-3\" aria-describedby=\"av-svg-desc-3\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-3\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-3\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4900\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-2pze4w-243b542d6af6bfa9cf747dc5f36ae894 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2pze4w-243b542d6af6bfa9cf747dc5f36ae894\">\n.flex_column.av-2pze4w-243b542d6af6bfa9cf747dc5f36ae894{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-2pze4w-243b542d6af6bfa9cf747dc5f36ae894 av_one_half  avia-builder-el-9  el_before_av_one_half  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  \"><\/div><div class=\"av-flex-placeholder\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-qeah6o-4b5441b64b02ac94116be3b1ea6aa2fe\">\n.flex_column.av-qeah6o-4b5441b64b02ac94116be3b1ea6aa2fe{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\nbackground-color:rgba(234,91,12,0.5);\n}\n<\/style>\n<div class=\"flex_column av-qeah6o-4b5441b64b02ac94116be3b1ea6aa2fe av_one_half  avia-builder-el-10  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle  \"><section class=\"av_textblock_section av-kl0mtsgh-b78587a0304cb920769651a9935e00a3 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>In concrete terms, this means that all processes, systems and activities directly and indirectly related to product manufacture must be validated \/ qualified and documented in an appropriate manner. In regulated industries, information relevant to product <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> is therefore part of the product. The product&lsquo;s documentation, use and availability require appropriate, validated systems.<\/p>\n<p>In our project work, we ensure that clear structures, demarcations and assignments create an efficient organisational and <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 that remains manageable at all times.<\/p>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mq53r4-900ed2d150ca976193974eb1056ce123\">\n.avia-section.av-mq53r4-900ed2d150ca976193974eb1056ce123 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-mq53r4-900ed2d150ca976193974eb1056ce123 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-mq53r4-900ed2d150ca976193974eb1056ce123 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_4\" class=\"avia-section av-mq53r4-900ed2d150ca976193974eb1056ce123 main_color avia-section-default avia-no-border-styling  avia-builder-el-12  el_after_av_section  el_before_av_postcontent  avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize\"><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><a 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av-hover-overlay-active av-masonry-animation-active av-masonry-col-4 av-caption-always av-caption-style-overlay av-masonry-entries \" data-post_id=\"4900\"><div class=\"av-masonry-container isotope av-js-disabled\"><div class=\"av-masonry-entry isotope-item av-masonry-item-no-image \"><\/div><a href=\"https:\/\/q-finity.de\/en\/ispe-ai-in-life-sciences-summit-with-qfinity-22-23-june-2026-2\/\" id=\"av-masonry-1-item-14517\" data-av-masonry-item=\"14517\" class=\"av-masonry-entry isotope-item post-14517 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">QFINITY will be represented at the ISPE AI in Life Sciences Summit&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">4. May 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/live-online-training-gxp-systems-digital-compliance-fundamentals-with-qfinity-08-may-2026\/\" id=\"av-masonry-1-item-14514\" data-av-masonry-item=\"14514\" class=\"av-masonry-entry isotope-item post-14514 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"Live online training &ldquo;GxP Systems &amp; Digital Compliance Fundamentals&rdquo; with QFINITY | 08. May 2026\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">Live online training &ldquo;GxP Systems &amp; Digital Compliance Fundamentals&rdquo; with QFINITY | 08. May 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">On 8 May 2026, the live online training &ldquo;GxP Systems &amp;&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">4. May 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/cloud-services\/\" id=\"av-masonry-1-item-14507\" data-av-masonry-item=\"14507\" class=\"av-masonry-entry isotope-item post-14507 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"Enabling GxP-Compliant Cloud Services through Global QMS Enhancement\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">Enabling GxP-Compliant Cloud Services through Global QMS Enhancement<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">In this case study, an existing quality management system was&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">26. April 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/it-quality-management\/\" id=\"av-masonry-1-item-14481\" data-av-masonry-item=\"14481\" class=\"av-masonry-entry isotope-item post-14481 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">In this case study, the focus is on the restoration of IT systems&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">8. April 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ccplpc-a3056721edf58e2d1c9b14722e207ad3\">\n.flex_column.av-ccplpc-a3056721edf58e2d1c9b14722e207ad3{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-ccplpc-a3056721edf58e2d1c9b14722e207ad3 av_one_half  avia-builder-el-18  el_after_av_one_full  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><p><\/p><div class=\"avia-buttonrow-wrap av-ahah5s-6fce467d6fe365ff10d87195baef0e5c avia-buttonrow-left  avia-builder-el-19  el_before_av_hr  avia-builder-el-first \">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9r84ao-07ab3d1e72fac74741032bb28ed79820\">\n#top #wrap_all .avia-button.av-9r84ao-07ab3d1e72fac74741032bb28ed79820{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-9r84ao-07ab3d1e72fac74741032bb28ed79820:hover{\ncolor:#ffffff;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-9r84ao-07ab3d1e72fac74741032bb28ed79820:hover .avia-svg-icon svg:first-child{\nfill:#ffffff;\nstroke:#ffffff;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-9r84ao-07ab3d1e72fac74741032bb28ed79820 avia-icon_select-yes-right-icon avia-size-x-large av-icon-on-hover avia-color-theme-color avia-font-color-theme-color\" aria-label=\"all news\"><span class=\"avia_iconbox_title\">all news<\/span><span class=\"avia_button_icon avia_button_icon_right avia-iconfont avia-font-entypo-fontello\" data-av_icon=\"&#59517;\" data-av_iconfont=\"entypo-fontello\"><\/span><span class=\"avia_button_background avia-button avia-color-theme-color-highlight\"><\/span><\/a>\n<\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-p6akg-0e7fbb57e97651019fa19f4e122486db\">\n#top .hr.hr-invisible.av-p6akg-0e7fbb57e97651019fa19f4e122486db{\nheight:50px;\n}\n<\/style>\n<div class=\"hr av-p6akg-0e7fbb57e97651019fa19f4e122486db hr-invisible  avia-builder-el-20  el_after_av_buttonrow  avia-builder-el-last \"><span class=\"hr-inner \"><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5iwkw0-fa520d7f8c32a1f3ca9e8bea691ff3ca\">\n.flex_column.av-5iwkw0-fa520d7f8c32a1f3ca9e8bea691ff3ca{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-5iwkw0-fa520d7f8c32a1f3ca9e8bea691ff3ca av_one_half  avia-builder-el-21  el_after_av_one_half  el_before_av_hr  flex_column_div av-zero-column-padding  column-top-margin\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4r1x7k-9cd4cc8f52e3471218aaad7d20e242cb\">\n#top .hr.hr-invisible.av-4r1x7k-9cd4cc8f52e3471218aaad7d20e242cb{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-4r1x7k-9cd4cc8f52e3471218aaad7d20e242cb hr-invisible  avia-builder-el-22  el_after_av_one_half  avia-builder-el-last \"><span class=\"hr-inner \"><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":4876,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4900","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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