{"id":4897,"date":"2021-03-02T14:35:21","date_gmt":"2021-03-02T13:35:21","guid":{"rendered":"https:\/\/q-finity.de\/bereiche\/prozess-compliance-und-qualitaetssicherung-fuer-klinische-pruefungen\/"},"modified":"2024-04-03T12:57:22","modified_gmt":"2024-04-03T10:57:22","slug":"process-compliance-and-quality-assurance-for-clinical-trials","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/service-areas\/process-compliance-and-quality-assurance-for-clinical-trials\/","title":{"rendered":"Process compliance and quality assurance for clinical trials"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-13kblb7-6b78056fb1bf0e5512aae0fbc691f952\">\n.avia-section.av-13kblb7-6b78056fb1bf0e5512aae0fbc691f952{\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-13kblb7-6b78056fb1bf0e5512aae0fbc691f952 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-13kblb7-6b78056fb1bf0e5512aae0fbc691f952 .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-13kblb7-6b78056fb1bf0e5512aae0fbc691f952 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 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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-4897\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kls1ycqt-55e5de66952635859c1ec382446b9d1a\">\n#top .av-special-heading.av-kls1ycqt-55e5de66952635859c1ec382446b9d1a{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls1ycqt-55e5de66952635859c1ec382446b9d1a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls1ycqt-55e5de66952635859c1ec382446b9d1a .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls1ycqt-55e5de66952635859c1ec382446b9d1a .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-kls1ycqt-55e5de66952635859c1ec382446b9d1a .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-kls1ycqt-55e5de66952635859c1ec382446b9d1a .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-kls1ycqt-55e5de66952635859c1ec382446b9d1a 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\">Process compliance and quality assurance for clinical trials<\/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-117gw6b-0a8d60824923dba95bb614b13b43dd16\">\n.avia-section.av-117gw6b-0a8d60824923dba95bb614b13b43dd16 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id=\"style-css-av-yxpndv-708c86a633a547a264488a1252ec1204\">\n.flex_column.av-yxpndv-708c86a633a547a264488a1252ec1204{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-yxpndv-708c86a633a547a264488a1252ec1204 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-kls1yp7m-f8039099db13644f6d2bfba7a13741c8\">\n#top .av-special-heading.av-kls1yp7m-f8039099db13644f6d2bfba7a13741c8{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls1yp7m-f8039099db13644f6d2bfba7a13741c8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls1yp7m-f8039099db13644f6d2bfba7a13741c8 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls1yp7m-f8039099db13644f6d2bfba7a13741c8 .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-kls1yp7m-f8039099db13644f6d2bfba7a13741c8 .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-kls1yp7m-f8039099db13644f6d2bfba7a13741c8 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-kls1yp7m-f8039099db13644f6d2bfba7a13741c8 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\">Process compliance and quality assurance<\/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>We provide consulting in the field of clinical research and development in all aspects of compliance management and the optimization of GCP processes. In addition to various audits, we offer consulting and support in the development or adaptation\/optimization of <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 for CROs, sponsors and various service providers. Workshops with <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> analyses for the improvement of <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> flows and for inspection preparation round off our service.<\/p>\n<p><strong><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> and integrity 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> along defined processes<\/strong><\/p>\n<p>In the field of clinical research on medicinal products, the safety of the study participants and the <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> and integrity of the <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> must be safeguarded through appropriate processes, which in turn must be assessed for compliance. Large financial investments are at stake, especially in research programmes in the pharmaceutical industry. Thus, <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> for clinical trials is required in many aspects: on the one hand, regulatory compliant and efficient processes have to be established, the responsible persons \/ service providers have to be trained or qualified and compliance with the requirements has to be reviewed regularly so that the sponsor or the trial centre can pass regulator inspections. As part of our <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>-oriented <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> approach, <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>&infin; offers support for various aspects of GCP compliance.<\/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-xdz1qb-9caaebc8bcfeec3dbf9183dd0c054ceb\">\n.flex_column.av-xdz1qb-9caaebc8bcfeec3dbf9183dd0c054ceb{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-xdz1qb-9caaebc8bcfeec3dbf9183dd0c054ceb 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-vnttlv-72c1ac4e8b73df5d40789d1f34c17000\">\n.avia-image-container.av-vnttlv-72c1ac4e8b73df5d40789d1f34c17000 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-vnttlv-72c1ac4e8b73df5d40789d1f34c17000 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-vnttlv-72c1ac4e8b73df5d40789d1f34c17000 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-tb4p37-f0a15726b8bca6c94fdc33ade631beda\">\n.avia-section.av-tb4p37-f0a15726b8bca6c94fdc33ade631beda{\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-tb4p37-f0a15726b8bca6c94fdc33ade631beda .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-tb4p37-f0a15726b8bca6c94fdc33ade631beda .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-tb4p37-f0a15726b8bca6c94fdc33ade631beda 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-4897\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-s0xo9f-4454145a8a7a24d5421465b269144683 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-s0xo9f-4454145a8a7a24d5421465b269144683\">\n.flex_column.av-s0xo9f-4454145a8a7a24d5421465b269144683{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-s0xo9f-4454145a8a7a24d5421465b269144683 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-qg9f6r-2a30249dbac5ea2397fc671194f91edc\">\n.flex_column.av-qg9f6r-2a30249dbac5ea2397fc671194f91edc{\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-qg9f6r-2a30249dbac5ea2397fc671194f91edc 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>When providing our services,&nbsp;<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>&infin; not only brings with it sound&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;expertise, but also profound IT knowledge, so that we are able to reflect and evaluate the associated IT systems right from the start when considering the&nbsp;processes. Thus, with every&nbsp;<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>&infin;&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a>, considerable cost efficiencies result from the inclusion of IT aspects in every&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a>, thereby elimination the need for separate IT&nbsp;audits. At the same time, the aspect of&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>&nbsp;in such&nbsp;audits is properly considered in all its facets through this interdisciplinary approach.<\/p>\n<p><strong>Our service in the area of Good Clinical Practice (GCP) Compliance:<\/strong><\/p>\n<ul>\n<li>Vendor\/Supplier Qualification&nbsp;Audits (Second-party&nbsp;audits), e.g. before and after contracting of CROs, laboratories, software service providers.<\/li>\n<li>GCP&nbsp;audits at clinical trial sites<\/li>\n<li>GCLP&nbsp;audits at clinical laboratories<\/li>\n<li>Mock&nbsp;audits as preparation for inspection<\/li>\n<li>First-party&nbsp;audits as an internal&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 measure<\/li>\n<li>Workshops for&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;analysis in the service of continuous improvement \/ efficiency enhancement<\/li>\n<\/ul>\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-26w0r7-807c9d23322a4a636d832581f4667b2a\">\n.avia-section.av-26w0r7-807c9d23322a4a636d832581f4667b2a .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-26w0r7-807c9d23322a4a636d832581f4667b2a .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-26w0r7-807c9d23322a4a636d832581f4667b2a .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-26w0r7-807c9d23322a4a636d832581f4667b2a 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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clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kjb3j7-ef6545cc0bc5978b6b580bac3dbc05ee\">\n.flex_column.av-kjb3j7-ef6545cc0bc5978b6b580bac3dbc05ee{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-kjb3j7-ef6545cc0bc5978b6b580bac3dbc05ee av_one_half  avia-builder-el-13  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-j6nzer-ccd96726ff8bc29035d75f89a2d7b891\">\n#top .av-special-heading.av-j6nzer-ccd96726ff8bc29035d75f89a2d7b891{\npadding-bottom:30px;\nfont-size:50px;\n}\nbody .av-special-heading.av-j6nzer-ccd96726ff8bc29035d75f89a2d7b891 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-j6nzer-ccd96726ff8bc29035d75f89a2d7b891 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-j6nzer-ccd96726ff8bc29035d75f89a2d7b891 .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-j6nzer-ccd96726ff8bc29035d75f89a2d7b891 .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-j6nzer-ccd96726ff8bc29035d75f89a2d7b891 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-j6nzer-ccd96726ff8bc29035d75f89a2d7b891 av-special-heading-h2 blockquote modern-quote  avia-builder-el-14  avia-builder-el-no-sibling  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Q_NEWS<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-h2vi3n-6d8fc832c0b10162358c0a192fa1f683\">\n.flex_column.av-h2vi3n-6d8fc832c0b10162358c0a192fa1f683{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-h2vi3n-6d8fc832c0b10162358c0a192fa1f683 av_one_half  avia-builder-el-15  el_after_av_one_half  el_before_av_one_full  flex_column_div av-zero-column-padding  \"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-g2oryb-4bd1ff2353a034863b29099715954f2d\">\n.flex_column.av-g2oryb-4bd1ff2353a034863b29099715954f2d{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-g2oryb-4bd1ff2353a034863b29099715954f2d av_one_full  avia-builder-el-16  el_after_av_one_half  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><div id=\"av-masonry-1\" class=\"av-masonry av-ea6o9v-43858f23a8e230a482ed3db574d12c7a noHover av-fixed-size av-large-gap 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=\"4897\"><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\/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--><a href=\"https:\/\/q-finity.de\/en\/global-qms-concept-case-study\/\" id=\"av-masonry-1-item-14470\" data-av-masonry-item=\"14470\" class=\"av-masonry-entry isotope-item post-14470 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"Global QMS concept for an international pharmaceutical company: design and implementation\" 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\">Global QMS concept for an international pharmaceutical company: design and implementation<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">This case study focuses on the design and implementation of a&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--><a href=\"https:\/\/q-finity.de\/en\/ispe-ai-in-life-sciences-summit-with-qfinity-22-23-june-2026\/\" id=\"av-masonry-1-item-14452\" data-av-masonry-item=\"14452\" class=\"av-masonry-entry isotope-item post-14452 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\">23. March 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\/ispe-eu-annual-conference-20-22-april-2026\/\" id=\"av-masonry-1-item-14436\" data-av-masonry-item=\"14436\" class=\"av-masonry-entry isotope-item post-14436 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"ISPE EU Annual Conference | 20.-22. April 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 EU Annual Conference | 20.-22. April 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">Meet QFINITY on site at the ISPE EU Annual Conference 2026 in&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">8. March 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-c0o04j-120b7339131d8244ed00664c2e39d45c\">\n.flex_column.av-c0o04j-120b7339131d8244ed00664c2e39d45c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-c0o04j-120b7339131d8244ed00664c2e39d45c 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-1153tf-f61b6dc6cf0a773fe6cab7b904537729 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-9dg5cj-fd318b7fae8df84860a23f4cb42ec9a7\">\n#top #wrap_all .avia-button.av-9dg5cj-fd318b7fae8df84860a23f4cb42ec9a7{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-9dg5cj-fd318b7fae8df84860a23f4cb42ec9a7:hover{\ncolor:#ffffff;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-9dg5cj-fd318b7fae8df84860a23f4cb42ec9a7:hover .avia-svg-icon svg:first-child{\nfill:#ffffff;\nstroke:#ffffff;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-9dg5cj-fd318b7fae8df84860a23f4cb42ec9a7 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-7ig8n7-1cdb9d78f3881a8dd70f44d81f4a7834\">\n#top .hr.hr-invisible.av-7ig8n7-1cdb9d78f3881a8dd70f44d81f4a7834{\nheight:50px;\n}\n<\/style>\n<div class=\"hr av-7ig8n7-1cdb9d78f3881a8dd70f44d81f4a7834 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-5zj037-51a38ba6d526854c68f5987ba29c4281\">\n.flex_column.av-5zj037-51a38ba6d526854c68f5987ba29c4281{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-5zj037-51a38ba6d526854c68f5987ba29c4281 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-47f9dv-63608a5c2dd03fcf0ad1dfc86b04b7e4\">\n#top .hr.hr-invisible.av-47f9dv-63608a5c2dd03fcf0ad1dfc86b04b7e4{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-47f9dv-63608a5c2dd03fcf0ad1dfc86b04b7e4 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-4897","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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