{"id":4882,"date":"2021-03-02T14:38:54","date_gmt":"2021-03-02T13:38:54","guid":{"rendered":"https:\/\/q-finity.de\/bereiche\/datenintegritaet-gcp-relevanter-computergestuetzter-systeme\/"},"modified":"2024-04-03T13:07:13","modified_gmt":"2024-04-03T11:07:13","slug":"validation-data-integrity-and-quality-assurance-of-gcp-relevant-computerized-systems","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/service-areas\/validation-data-integrity-and-quality-assurance-of-gcp-relevant-computerized-systems\/","title":{"rendered":"Validation, data integrity and quality assurance of GCP-relevant computerized systems"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-12xzep1-2d0c9573a2792436936aaa6c28e43c25\">\n.avia-section.av-12xzep1-2d0c9573a2792436936aaa6c28e43c25{\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-12xzep1-2d0c9573a2792436936aaa6c28e43c25 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-12xzep1-2d0c9573a2792436936aaa6c28e43c25 .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-12xzep1-2d0c9573a2792436936aaa6c28e43c25 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-4882\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711\">\n#top .av-special-heading.av-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711 .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-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711 .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-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-kls21ll3-d5c34b8dd26e89f2b16b09e8cc936711 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, data integrity and quality assurance of GCP-relevant 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-11ose5x-802aa76b6585bcb6d1a4508ea32c33a5\">\n.avia-section.av-11ose5x-802aa76b6585bcb6d1a4508ea32c33a5 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-11ose5x-802aa76b6585bcb6d1a4508ea32c33a5 .scroll-down-link{\ncolor:#ea5b0c;\n}\n#top .avia-section.av-11ose5x-802aa76b6585bcb6d1a4508ea32c33a5 .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-11ose5x-802aa76b6585bcb6d1a4508ea32c33a5 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-4882\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-ze92kl-370d03e584a58c808490777b9b1a18ea sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ze92kl-370d03e584a58c808490777b9b1a18ea\">\n.flex_column.av-ze92kl-370d03e584a58c808490777b9b1a18ea{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-ze92kl-370d03e584a58c808490777b9b1a18ea 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-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d\">\n#top .av-special-heading.av-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d .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-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d .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-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-kls21wxa-ecb9cea5e91a6a429585040b56ebc96d 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\">data integrity<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-kl0mtsgh-a8ce22d973a47cc5a6fa182f3b715e07 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>We explain how to ensure the <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> of GCP-relevant computerized systems.<\/p>\n<p>We provide consulting in the field of clinical research and development, both in <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> optimization and in the development 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. In addition, we support CROs, service providers and software developers in meeting the high demands on the validity of processes 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> as well as the suitability of the software tools used.<\/p>\n<p><strong>Efficiency and cost control through <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> orientation and risk-based technology deployment<\/strong><\/p>\n<p>In the field of clinical drug research, the requirements for computerized systems and processes that support the setup, execution and subsequent evaluation of clinical trials are particularly high. On the one hand, patient safety is a priority during ongoing studies; on the other hand, the <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> of the acquired <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> needs to be guaranteed. Both aspects (patient safety 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>) can be achieved through <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>.<\/p>\n<p><strong>In particular, the development and application of technologies such as<\/strong><\/p>\n<ul>\n<li>eCRF and EDC<\/li>\n<li>eSource technologies (e.g. electronic Patient Reported Outcomes &ndash; ePRO),<\/li>\n<li>IVRS \/ IWRS and<\/li>\n<li>eClinical platforms<\/li>\n<\/ul>\n<p>represents a particular challenge. Heterogeneous system landscapes with many different (often non-standardized) interfaces and many users worldwide pose a high risk to the <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> of the collected and processed <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>.<\/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-ypl2z9-cdd3cd633deed0bd7eae7f60e3ed5e06\">\n.flex_column.av-ypl2z9-cdd3cd633deed0bd7eae7f60e3ed5e06{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-ypl2z9-cdd3cd633deed0bd7eae7f60e3ed5e06 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-wxj9px-cf78245c531951dc7e2ce6ebb7a158d5\">\n.avia-image-container.av-wxj9px-cf78245c531951dc7e2ce6ebb7a158d5 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-wxj9px-cf78245c531951dc7e2ce6ebb7a158d5 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-wxj9px-cf78245c531951dc7e2ce6ebb7a158d5 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-t1lret-940b1c30660e1a323ceac5be28921627\">\n.avia-section.av-t1lret-940b1c30660e1a323ceac5be28921627{\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-t1lret-940b1c30660e1a323ceac5be28921627 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-t1lret-940b1c30660e1a323ceac5be28921627 .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-t1lret-940b1c30660e1a323ceac5be28921627 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-4882\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-r2j17p-aea6270864eb0581c98b915a8ff5f428 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-r2j17p-aea6270864eb0581c98b915a8ff5f428\">\n.flex_column.av-r2j17p-aea6270864eb0581c98b915a8ff5f428{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-r2j17p-aea6270864eb0581c98b915a8ff5f428 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-p52ls5-08f74eef0b9248534fb91282bdf4668d\">\n.flex_column.av-p52ls5-08f74eef0b9248534fb91282bdf4668d{\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-p52ls5-08f74eef0b9248534fb91282bdf4668d 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-a8ce22d973a47cc5a6fa182f3b715e07 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>By applying the GAMP 5&reg; principles to the&nbsp;processes and system landscapes in this field, a targeted validation of such systems can be realized. The application of this&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>-oriented, risk-based approach for the validation of GCP&nbsp;processes and the qualification of the IT systems that support these&nbsp;processes allows a resource-friendly&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>&nbsp;for these already very costly projects. Even highly complex eClinical Platforms can be efficiently qualified using end-to-end validation.<\/p>\n<h2><strong>Our service in the area of Good Clinical Practice (GCP)<\/strong><\/h2>\n<ul>\n<li>Consulting for&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 of GCP&nbsp;<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>&nbsp;and systems<\/li>\n<li>Development and optimization of&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>&nbsp;systems (QMS)<\/li>\n<li>Trainings and Workshops<\/li>\n<li>Support in&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;and change management<\/li>\n<li>Efficient validation strategies<\/li>\n<li>Support of sponsors and suppliers (e.g. CROs, laboratories)<\/li>\n<li>Support in tool selection and supplier evaluation<\/li>\n<li>Auditing of software suppliers (on-site)<\/li>\n<li>Migration planning and concepts<\/li>\n<li><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 and optimization when using&nbsp;computerized GCP systems<\/li>\n<li>Performing&nbsp;<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>&nbsp;flow 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>&nbsp;analyses<\/li>\n<li>Operational support in the implementation of validation activities<\/li>\n<li>Testing of GCP-compliant archiving systems and document management systems<\/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-mn4fph-04387a8e62840c1e4ef7bba7a3a905d4\">\n.avia-section.av-mn4fph-04387a8e62840c1e4ef7bba7a3a905d4 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-mn4fph-04387a8e62840c1e4ef7bba7a3a905d4 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-mn4fph-04387a8e62840c1e4ef7bba7a3a905d4 .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-mn4fph-04387a8e62840c1e4ef7bba7a3a905d4 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-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-jklqol-c8b2924297ab5977a7dfc7bd76e4aeb7 .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-jklqol-c8b2924297ab5977a7dfc7bd76e4aeb7 .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-jklqol-c8b2924297ab5977a7dfc7bd76e4aeb7 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-jklqol-c8b2924297ab5977a7dfc7bd76e4aeb7 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-hr8k6d-8035b8b163f4ee26fc882111d7bd790e\">\n.flex_column.av-hr8k6d-8035b8b163f4ee26fc882111d7bd790e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-hr8k6d-8035b8b163f4ee26fc882111d7bd790e 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-g4m7yd-021a64dbe87173f347a97e95ffbe4142\">\n.flex_column.av-g4m7yd-021a64dbe87173f347a97e95ffbe4142{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-g4m7yd-021a64dbe87173f347a97e95ffbe4142 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-einvxh-260544846eb5c9b3fedd6dcae6222237 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=\"4882\"><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-cdhgs5-e371a69b97be6c2078f09e086efb6065\">\n.flex_column.av-cdhgs5-e371a69b97be6c2078f09e086efb6065{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-cdhgs5-e371a69b97be6c2078f09e086efb6065 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-aobtit-a5e743882c503d55a3deb0e16215babc 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-99gz11-2af4fc4c9f80375a112ca10650658797\">\n#top #wrap_all .avia-button.av-99gz11-2af4fc4c9f80375a112ca10650658797{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-99gz11-2af4fc4c9f80375a112ca10650658797:hover{\ncolor:#ffffff;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-99gz11-2af4fc4c9f80375a112ca10650658797:hover .avia-svg-icon svg:first-child{\nfill:#ffffff;\nstroke:#ffffff;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-99gz11-2af4fc4c9f80375a112ca10650658797 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-q3atx-ab653a928863cd18b600d063bcf7a346\">\n#top .hr.hr-invisible.av-q3atx-ab653a928863cd18b600d063bcf7a346{\nheight:50px;\n}\n<\/style>\n<div class=\"hr av-q3atx-ab653a928863cd18b600d063bcf7a346 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-68ppyd-67d2777ce9627cc3fee532cbd71736ed\">\n.flex_column.av-68ppyd-67d2777ce9627cc3fee532cbd71736ed{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-68ppyd-67d2777ce9627cc3fee532cbd71736ed 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-41mxdx-b97f8b73631b9880d5557e24757d18ec\">\n#top .hr.hr-invisible.av-41mxdx-b97f8b73631b9880d5557e24757d18ec{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-41mxdx-b97f8b73631b9880d5557e24757d18ec 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-4882","page","type-page","status-publish","hentry"],"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>Data integrity of GCP-relevant computerized systems<\/title>\n<meta name=\"description\" content=\"We explain how you can ensure or optimize the data integrity of GCP-relevant computerized systems. 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