{"id":4964,"date":"2021-03-03T10:08:26","date_gmt":"2021-03-03T09:08:26","guid":{"rendered":"https:\/\/q-finity.de\/publikationen\/"},"modified":"2025-01-10T13:12:40","modified_gmt":"2025-01-10T12:12:40","slug":"publications","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/company\/publications\/","title":{"rendered":"Publications"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkznp0yn-ce6a674f59bc0dda3b29f6452bb80161\">\n.avia-section.av-kkznp0yn-ce6a674f59bc0dda3b29f6452bb80161 .av-parallax .av-parallax-inner{\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\/illu_company_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n#top .avia-section.av-kkznp0yn-ce6a674f59bc0dda3b29f6452bb80161 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-kkznp0yn-ce6a674f59bc0dda3b29f6452bb80161 .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-kkznp0yn-ce6a674f59bc0dda3b29f6452bb80161 alternate_color avia-section-large avia-no-border-styling  avia-builder-el-0  el_before_av_textblock  avia-builder-el-first  avia-full-stretch av-parallax-section avia-bg-style-parallax av-minimum-height av-minimum-height-50 av-height-50  container_wrap fullsize\" data-section-bg-repeat=\"stretch\" data-av_minimum_height_pc=\"50\" data-av_min_height_opt=\"50\"><div class=\"av-parallax\" data-avia-parallax-ratio=\"0.3\"><div class=\"av-parallax-inner alternate_color avia-full-stretch\"><\/div><\/div><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-klt7abwp-bf74b69669952bb87f8c717139d869f3\">\n#top .av-special-heading.av-klt7abwp-bf74b69669952bb87f8c717139d869f3{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-klt7abwp-bf74b69669952bb87f8c717139d869f3 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-klt7abwp-bf74b69669952bb87f8c717139d869f3 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-klt7abwp-bf74b69669952bb87f8c717139d869f3 .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-klt7abwp-bf74b69669952bb87f8c717139d869f3 .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-klt7abwp-bf74b69669952bb87f8c717139d869f3 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-klt7abwp-bf74b69669952bb87f8c717139d869f3 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\">QFINITY &ndash; Our Publications<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id=\"after_section_1\" class=\"main_color av_default_container_wrap container_wrap fullsize\"><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<section class=\"av_textblock_section av-av_textblock-9ee6daaf882f31bf75966532cda9493c \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><\/div><\/section>\n<div class=\"flex_column av-av_one_full-41ee899840124b6993b57a87f996c353 av_one_full  avia-builder-el-3  el_after_av_textblock  el_before_av_section  avia-builder-el-last  first flex_column_div  column-top-margin\"><section class=\"av_textblock_section av-lzbfyztr-15894b5c32ccd15c08355c7a6614b85a \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>Here you will find an overview of the publications and papers in which <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> employees have been significantly involved. Several of these publications are considered standard works in the industry and influence the day-to-day work of the industry.<\/p>\n<\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_2\" class=\"avia-section av-av_section-e4ef95e6d64daa5d43c9bd2540e73530 main_color avia-section-default avia-no-border-styling  avia-builder-el-5  el_after_av_one_full  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-a2cef933b0a555f25d1e39b22a8e9dae av_one_half  avia-builder-el-6  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m5qpjgdu-0e24b993f79da3b1faa319ff7cdb5c64\">\n.avia-image-container.av-m5qpjgdu-0e24b993f79da3b1faa319ff7cdb5c64 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-m5qpjgdu-0e24b993f79da3b1faa319ff7cdb5c64 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-m5qpjgdu-0e24b993f79da3b1faa319ff7cdb5c64 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=1153649642  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-13645 avia-img-lazy-loading-not-13645 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/01\/Bildschirmfoto-2025-01-10-um-12.53.39.png\" alt=\"\" title=\"Bildschirmfoto 2025-01-10 um 12.53.39\" height=\"300\" width=\"300\" itemprop=\"thumbnailUrl\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/01\/Bildschirmfoto-2025-01-10-um-12.53.39.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:80\/h:80\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/01\/Bildschirmfoto-2025-01-10-um-12.53.39.png 80w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:36\/h:36\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/01\/Bildschirmfoto-2025-01-10-um-12.53.39.png 36w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:180\/h:180\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/01\/Bildschirmfoto-2025-01-10-um-12.53.39.png 180w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:696\/h:698\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2025\/01\/Bildschirmfoto-2025-01-10-um-12.53.39.png 696w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><\/div><\/div><div class=\"flex_column av-av_one_half-538dd737667e19053994a94b9156413b av_one_half  avia-builder-el-8  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m5qpibnk-1d03bf82f5650ee777b6b321d4bed23f\">\n#top .av-special-heading.av-m5qpibnk-1d03bf82f5650ee777b6b321d4bed23f{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-m5qpibnk-1d03bf82f5650ee777b6b321d4bed23f .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-m5qpibnk-1d03bf82f5650ee777b6b321d4bed23f .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-m5qpibnk-1d03bf82f5650ee777b6b321d4bed23f .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-m5qpibnk-1d03bf82f5650ee777b6b321d4bed23f av-special-heading-h2  avia-builder-el-9  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Article in Pharmaceutical Engineering on the topic of Disaster Recovery<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-m5qphyli-61c8c4673250f06bfa6c37c9e03a7bd5 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p><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> has authored an article highlighting the role 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> in disaster recovery for regulated environments. The article explores practical steps to ensure compliance and operational efficiency during IT-related crises, particularly in the context of ransomware attacks. It emphasizes the importance of robust disaster recovery (DR) and business continuity planning. Additionally, it addresses challenges such as ensuring <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>, managing interim processes, and the impact on infrastructure qualification. The article underscores the importance of pre-established plans, meticulous documentation, and practical, <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>-oriented decision-making to efficiently restore <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> and systems while maintaining compliance with regulatory requirements, 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>, and patient safety.<\/p>\n<p>Further links: Read the article <a href=\"https:\/\/ispe.org\/pharmaceutical-engineering\/january-february-2024\/quality-considerations-disaster-recovery-case\">here<\/a>.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_3\" class=\"avia-section av-av_section-8c038a69d7b065b313c8996090138e7a main_color avia-section-default avia-no-border-styling  avia-builder-el-11  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-12  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lzbfvmy7-eb37a7fc078530f78e23aaa9653314ab\">\n#top .av-special-heading.av-lzbfvmy7-eb37a7fc078530f78e23aaa9653314ab{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-lzbfvmy7-eb37a7fc078530f78e23aaa9653314ab .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lzbfvmy7-eb37a7fc078530f78e23aaa9653314ab .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lzbfvmy7-eb37a7fc078530f78e23aaa9653314ab .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lzbfvmy7-eb37a7fc078530f78e23aaa9653314ab av-special-heading-h2  avia-builder-el-13  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">GAMP Good Practice Guide: Computer GCP Systems and Data 2nd Edition<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lzbftwlu-6346b1df49a16c916626a449eeeb6baa \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>The ISPE has just published the second edition of the GAMP Guide to Good Practice for Validation and Compliance of Computerized Clinical Systems and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a>. More than 50 industry experts, including <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> experts, have worked on the second edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> currently available.<\/p>\n<p>The update to the first edition, which was published in 2017, was necessary as significant progress has been made in the conduct of clinical trials in recent years. Some of these changes, such as decentralized clinical trials, have been accelerated by the COVID-19 pandemic. The changes in the industry have also prompted regulators to issue guidance such as the EMA&rsquo;s &ldquo;Guideline on computerized systems and electronic <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> in clinical trials&rdquo; and the &ldquo;Notice to sponsors on the validation and qualification of computerized systems for clinical trials&rdquo;, which have been taken into account when updating the guide. The content was also significantly expanded to include information on real world <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> \/ real world evidence, <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> protection in clinical trials, artificial intelligence 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> science, and decentralized clinical trials. Last but not least, the guideline had to be adapted to the 2nd edition of GAMP 5.<\/p>\n<p>Further links: click <a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-computerized-gcp-systems-data-2nd-edition\">here<\/a> to order now!<\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-15  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lzbfu74o-e5a8b0745437eccc116be9c6cb1a491e\">\n.avia-image-container.av-lzbfu74o-e5a8b0745437eccc116be9c6cb1a491e img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lzbfu74o-e5a8b0745437eccc116be9c6cb1a491e .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-lzbfu74o-e5a8b0745437eccc116be9c6cb1a491e av-styling- avia-align-center  avia-builder-el-16  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=1417561457  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-13251 avia-img-lazy-loading-not-13251 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:285\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png\" alt=\"\" title=\"Bildschirmfoto 2024-08-01 um 16.41.06\" height=\"285\" width=\"300\" itemprop=\"thumbnailUrl\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:285\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:730\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:670\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 705w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:844\/h:802\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 844w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_4\" class=\"avia-section av-lt8izo6w-36d6672a8a10644850705bb814e35a3a main_color avia-section-default avia-no-border-styling  avia-builder-el-17  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div 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298px\"><\/div><\/div><\/div><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-20  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-m5qplq1h-cf5f4ff41c15757215825405a71346ae\">\n#top .av-special-heading.av-m5qplq1h-cf5f4ff41c15757215825405a71346ae{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-m5qplq1h-cf5f4ff41c15757215825405a71346ae .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-m5qplq1h-cf5f4ff41c15757215825405a71346ae .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-m5qplq1h-cf5f4ff41c15757215825405a71346ae .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-m5qplq1h-cf5f4ff41c15757215825405a71346ae av-special-heading-h2  avia-builder-el-21  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Leitfaden Klinische Pr&uuml;fungen von Arzneimitteln und Medizinprodukten<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-ls5vkx1l-e626849794e98954f0bf92c968b08d8e \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>On 1 February 2024, the 5th edition of the renowned work &ldquo;Leitfaden Klinische Pr&uuml;fungen von Arzneimitteln und Medizinprodukten&rdquo; was published. Edited by B. Sickm&uuml;ller, Ch. Gleiter and C. Hinze, with contributions from many experts, present a complete revision and expansion of the content in this latest edition. The book serves as a standard work and reference in its field and covers a wide range of topics. It examines in detail the regulations and methods of clinical research, including the practical conduct of studies, with a particular focus on clinical pharmacological aspects. In addition, it addresses crucial issues relating to the safety of medicinal products and medical devices in clinical trials.<\/p>\n<p><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> is pleased to have contributed to this edition. Marcus Schwabedissen, Frank Henrichmann, Dr Jenny Gebhardt and Oliver Herrmann have written the chapter on &ldquo;Validation of computerised systems&rdquo;. This book is a comprehensive resource for drug and medical device research professionals.<\/p>\n<p>further links: <a href=\"https:\/\/www.ecv.de\/suse_item.php?suseId=P%7CC%7C7062&amp;susePattern=Leitfaden%2520Klinische%2520Pr%25C3%25BCfungen\">find out more and order here<\/a>.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_5\" class=\"avia-section av-lt8izst0-5cb5f3c3ad46b42cf751d719ec67bbd1 main_color avia-section-default avia-no-border-styling  avia-builder-el-23  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-a961ec8c42a44a397321d1a2224da3ca av_one_half  avia-builder-el-24  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lg25elrs-79f0b5e682b438068eb33fc5279f71c8\">\n#top .av-special-heading.av-lg25elrs-79f0b5e682b438068eb33fc5279f71c8{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lg25elrs-79f0b5e682b438068eb33fc5279f71c8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lg25elrs-79f0b5e682b438068eb33fc5279f71c8 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lg25elrs-79f0b5e682b438068eb33fc5279f71c8 .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-lg25elrs-79f0b5e682b438068eb33fc5279f71c8 .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-lg25elrs-79f0b5e682b438068eb33fc5279f71c8 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lg25elrs-79f0b5e682b438068eb33fc5279f71c8 av-special-heading-h2 blockquote modern-quote  avia-builder-el-25  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">GAMP 5 Guide 2nd Edition<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lg25dw1s-0dbb9f0275023a3fe79ced78df8a0423 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p style=\"font-weight: 400;\">Maintaining the principles and framework of the first edition, published in 2008, the second edition provides updates for applications in the modern world. That includes the increasing importance of service providers, evolving approaches to software development, and the expanded use of software tools and automation. The authors, which include <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>&rsquo;s Oliver Herrmann and Frank Henrichmann, also emphasize the importance of &ldquo;<a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">critical thinking<\/a>&rdquo; by knowledgeable and experienced SMEs in defining the reliable approach to probability.<\/p>\n<p style=\"font-weight: 400;\">further links:&nbsp;<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\">find out more and order here now<\/a><\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-e38f08a368d22f46ed35f78008f927bf av_one_half  avia-builder-el-27  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lg25a6s4-20d849327eead5ecdd568138ac1a533a\">\n.avia-image-container.av-lg25a6s4-20d849327eead5ecdd568138ac1a533a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lg25a6s4-20d849327eead5ecdd568138ac1a533a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-lg25a6s4-20d849327eead5ecdd568138ac1a533a av-styling- avia-align-center  avia-builder-el-28  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=1415263730  data-opt-src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:274\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-09.50.41.png\"  decoding=\"async\"  class=\"wp-image-12688 avia-img-lazy-loading-not-12688 avia_image \" src=\"data:image/svg+xml,%3Csvg%20viewBox%3D%220%200%20300%20274%22%20width%3D%22300%22%20height%3D%22274%22%20xmlns%3D%22http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%22%3E%3Crect%20width%3D%22300%22%20height%3D%22274%22%20fill%3D%22transparent%22%2F%3E%3C%2Fsvg%3E\" alt=\"\" title=\"Bildschirmfoto 2024-04-06 um 09.50.41\" height=\"274\" width=\"300\" itemprop=\"thumbnailUrl\" old-srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:274\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-09.50.41.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:701\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-09.50.41.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:643\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-09.50.41.png 705w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:842\/h:768\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-09.50.41.png 842w\"><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_6\" class=\"avia-section av-lt8j00is-964ba9f70748bc7360753e2d8102d645 main_color avia-section-default avia-no-border-styling  avia-builder-el-29  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize\"><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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-a961ec8c42a44a397321d1a2224da3ca av_one_half  avia-builder-el-30  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgmfdhd5-d5abd52190062b0e774ec427a8294dcb\">\n.avia-image-container.av-lgmfdhd5-d5abd52190062b0e774ec427a8294dcb img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lgmfdhd5-d5abd52190062b0e774ec427a8294dcb .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-lgmfdhd5-d5abd52190062b0e774ec427a8294dcb av-styling- avia-align-center  avia-builder-el-31  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=885952773  data-opt-src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:293\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-10.06.21.png\"  decoding=\"async\"  class=\"wp-image-12690 avia-img-lazy-loading-not-12690 avia_image \" src=\"data:image/svg+xml,%3Csvg%20viewBox%3D%220%200%20293%20300%22%20width%3D%22293%22%20height%3D%22300%22%20xmlns%3D%22http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%22%3E%3Crect%20width%3D%22293%22%20height%3D%22300%22%20fill%3D%22transparent%22%2F%3E%3C%2Fsvg%3E\" alt=\"\" title=\"Bildschirmfoto 2024-04-06 um 10.06.21\" height=\"300\" width=\"293\" itemprop=\"thumbnailUrl\" old-srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:293\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-10.06.21.png 293w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:36\/h:36\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-10.06.21.png 36w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:688\/h:705\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-10.06.21.png 688w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:738\/h:756\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/04\/Bildschirmfoto-2024-04-06-um-10.06.21.png 738w\"><\/div><\/div><\/div><\/div><div class=\"flex_column av-av_one_half-e38f08a368d22f46ed35f78008f927bf av_one_half  avia-builder-el-32  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1\">\n#top .av-special-heading.av-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1 .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-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1 .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-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lgmfgesc-f9d0d943418e0f9c7652b5fd9275dcf1 av-special-heading-h2 blockquote modern-quote  avia-builder-el-33  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">ISPE GAMP Good Practice Guide: Enabling Innovation<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lgmffsux-440154e9ff96583aa9fc0aaa413d6971 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>The ISPE GAMP&reg; Good Practice Guide: Enabling Innovation &ndash; <a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">Critical Thinking<\/a>, Agile, IT Service Management provides information to assist with:<\/p>\n<p>&ndash; Introducing new and improved approaches to software engineering,<\/p>\n<p>&ndash; the use of &ldquo;as a service&rdquo; (XaaS) offerings, including the use of supporting tools.<\/p>\n<p>The Guide helps regulated organizations identify appropriate <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 validation approaches to make the best use of their resources.<\/p>\n<p>In this GAMP&reg; Good Practice Guide, the authors, which include Oliver Herrmann and Frank Henrichmann of <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>, discuss how <a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">critical thinking<\/a> based on product and <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> knowledge, as well as <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> risk management, helps to remove potential barriers when introducing new and innovative technologies.<\/p>\n<p>further links:&nbsp;<a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-enabling-innovation\">find out more and order here<\/a><\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kl0mv5v5-2a78d9422054d4b6883eec081e271d2c\">\n.avia-section.av-kl0mv5v5-2a78d9422054d4b6883eec081e271d2c .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-kl0mv5v5-2a78d9422054d4b6883eec081e271d2c .scroll-down-link{\ncolor:#ea5b0c;\n}\n#top .avia-section.av-kl0mv5v5-2a78d9422054d4b6883eec081e271d2c .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ea5b0c;\nfill:#ea5b0c;\n}\n<\/style>\n<div 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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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-kl0mg4da-b9650753e2909b16ee78542b2f7ef2b2 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kl0mg4da-b9650753e2909b16ee78542b2f7ef2b2\">\n.flex_column.av-kl0mg4da-b9650753e2909b16ee78542b2f7ef2b2{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-kl0mg4da-b9650753e2909b16ee78542b2f7ef2b2 av_one_half  avia-builder-el-36  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-klt7am13-2e93637dc359691fcb7e84deaed2fbd0\">\n#top .av-special-heading.av-klt7am13-2e93637dc359691fcb7e84deaed2fbd0{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-klt7am13-2e93637dc359691fcb7e84deaed2fbd0 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-klt7am13-2e93637dc359691fcb7e84deaed2fbd0 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-klt7am13-2e93637dc359691fcb7e84deaed2fbd0 .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-klt7am13-2e93637dc359691fcb7e84deaed2fbd0 .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-klt7am13-2e93637dc359691fcb7e84deaed2fbd0 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-klt7am13-2e93637dc359691fcb7e84deaed2fbd0 av-special-heading-h2 blockquote modern-quote  avia-builder-el-37  el_before_av_heading  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\"> ISPE GAMP Good Practice Guide (GPG):<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km3movhj-572194fc057958b344847f2d508654ab\">\n#top .av-special-heading.av-km3movhj-572194fc057958b344847f2d508654ab{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-km3movhj-572194fc057958b344847f2d508654ab .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-km3movhj-572194fc057958b344847f2d508654ab .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div class=\"av-special-heading av-km3movhj-572194fc057958b344847f2d508654ab av-special-heading-h3 blockquote modern-quote  avia-builder-el-38  el_after_av_heading  el_before_av_textblock \"><h3 class=\"av-special-heading-tag \" itemprop=\"headline\">Validation and Compliance of Computerized GCP Systems and Data &ndash; Good eClinical Practice<\/h3><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>This ISPE GAMP GPG on compliant systems in clinical research offers recommendations on how to meet the specific challenges of the 21st century in the validation and operation of&nbsp;computerized systems in the GCP field. The authors of the guide, including&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><sup>&infin;<\/sup>&rsquo;s Oliver Herrmann and Dr. Jenny Gebhardt, consider the increasing number, complexity, costs and patient centricity of clinical trials and focus on the need to implement a new model of a virtually integrated drug development&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>. 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>&nbsp;must be supported by highly integrated&nbsp;computerized systems (from statistical programming platforms,&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;capture systems and Interactive Response Technologies (IRT) solutions to mobile electronic patient diaries and, in the near future, wearables) to collect,&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;and analyse clinical&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>. This guide addresses all of these issues, which represent a major challenge for ensuring adequate control by sponsors and other stakeholders such as CROs and technology providers.<\/p>\n<p><em>F<\/em>urther links: <a href=\"https:\/\/www.ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-gcp-systems-data\" target=\"_blank\" rel=\"noopener\">Get more information and<\/a><a href=\"https:\/\/www.ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-gcp-systems-data\" target=\"_blank\" rel=\"noopener\"> order now here!<\/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-5ay7t9-8fba289bb5addf7d7641848e003cc007\">\n.flex_column.av-5ay7t9-8fba289bb5addf7d7641848e003cc007{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-5ay7t9-8fba289bb5addf7d7641848e003cc007 av_one_half  avia-builder-el-40  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-klt7ycs5-69bd49d53f4a88ae81c814f40e3d1a9e\">\n.avia-image-container.av-klt7ycs5-69bd49d53f4a88ae81c814f40e3d1a9e img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-klt7ycs5-69bd49d53f4a88ae81c814f40e3d1a9e .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-klt7ycs5-69bd49d53f4a88ae81c814f40e3d1a9e av-styling- avia-align-center  avia-builder-el-41  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=1828692996  data-opt-src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/GampGPG12-eClinical_smcvr.png\"  decoding=\"async\"  class=\"wp-image-4783 avia-img-lazy-loading-not-4783 avia_image \" src=\"data:image/svg+xml,%3Csvg%20viewBox%3D%220%200%20100%%20100%%22%20width%3D%22100%%22%20height%3D%22100%%22%20xmlns%3D%22http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%22%3E%3Crect%20width%3D%22100%%22%20height%3D%22100%%22%20fill%3D%22transparent%22%2F%3E%3C%2Fsvg%3E\" alt=\"\" title=\"GampGPG12-eClinical_smcvr\" height=\"300\" width=\"300\" itemprop=\"thumbnailUrl\" old-srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/GampGPG12-eClinical_smcvr.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:80\/h:80\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/GampGPG12-eClinical_smcvr.png 80w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:36\/h:36\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/GampGPG12-eClinical_smcvr.png 36w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:180\/h:180\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/GampGPG12-eClinical_smcvr.png 180w\"><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. 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old-srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:300\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/ECV_Buch_IT-Trends_rgb_500px_2B_SC-300x300-1.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:80\/h:80\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/ECV_Buch_IT-Trends_rgb_500px_2B_SC-300x300-1.png 80w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:36\/h:36\/q:mauto\/f:best\/dpr:2\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/ECV_Buch_IT-Trends_rgb_500px_2B_SC-300x300-1.png 36w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:180\/h:180\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/ECV_Buch_IT-Trends_rgb_500px_2B_SC-300x300-1.png 180w\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-hafp25-19f41656cbafa47b4275eb1d6ea98c4f\">\n.flex_column.av-hafp25-19f41656cbafa47b4275eb1d6ea98c4f{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\nbackground-color:#ffffff;\n}\n<\/style>\n<div class=\"flex_column av-hafp25-19f41656cbafa47b4275eb1d6ea98c4f av_one_half  avia-builder-el-45  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959\">\n#top .av-special-heading.av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959{\npadding-bottom:10px;\ncolor:#ea5a0c;\nfont-size:50px;\n}\nbody .av-special-heading.av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 .special-heading-inner-border{\nborder-color:#ea5a0c;\n}\n.av-special-heading.av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 .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-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 .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-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-klt7h8z4-91831ff0221bfd0d8436dc8c18bd5959 av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-46  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">PUBLICATION: PHARMA TECHNOLOGY JOURNAL &ndash; IT-TRENDS IN THE GXP-FIELD<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kl0mtsgh-63bdb3d9c2d37498ed7f73f24bda06e3\">\n#top .av_textblock_section.av-kl0mtsgh-63bdb3d9c2d37498ed7f73f24bda06e3 .avia_textblock{\ncolor:#000000;\n}\n<\/style>\n<section class=\"av_textblock_section av-kl0mtsgh-63bdb3d9c2d37498ed7f73f24bda06e3 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><p>Renowned authors from industry, consulting and suppliers provide insight into current trends and their practical application in the GxP area.&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; is represented among the authors by Oliver Herrmann and Dr. Jenny Gebhardt (&ldquo;Validation of&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/computer\/\" target=\"_self\" title=\"A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention. If you need more information please contact us here.\" class=\"encyclopedia\">computer<\/a>-based GCP systems: Grundlagen, Ans&auml;tze, Herausforderungen und Trends&rdquo;) and Dr. Stefan Schaaf (&ldquo;Enterprise Management Systems as a Basis for GxP Compliance in the Life Science Industry&rdquo;).<\/p>\n<p>Further Links:&nbsp;<a title=\"GCP GAMP Validierung Oliver Herrmann Jenny Gebhardt Stefan Schaaf QFINITY&infin;\" href=\"http:\/\/www.ecv.de\/Buecher\/ITTrends_im_GxPUmfeld?utm_source=CleverReach&amp;utm_medium=email&amp;utm_campaign=09-09-2015+pharmind+%7C+Infoletter+09\/15+allgemein&amp;utm_content=Mailing_9357861\">Get more information and order now here!<\/a>&nbsp;&ndash; ISBN: 978-3-87193-302-8<\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" 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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-4\" aria-describedby=\"av-svg-desc-4\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-4\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-4\">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-4964\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-kl0mg4da-b9650753e2909b16ee78542b2f7ef2b2 sc-av_one_half 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.av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-4rg2ip-db33aa3b6c2672e9b2ba35a0e8ed8d32 .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-4rg2ip-db33aa3b6c2672e9b2ba35a0e8ed8d32 .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-4rg2ip-db33aa3b6c2672e9b2ba35a0e8ed8d32 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-4rg2ip-db33aa3b6c2672e9b2ba35a0e8ed8d32 av-special-heading-h2 blockquote modern-quote  avia-builder-el-50  el_before_av_heading  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Computerized systems in the GCP environment:<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km3mpozn-7a5f7920dc7404b48c14c1fb77f74840\">\n#top .av-special-heading.av-km3mpozn-7a5f7920dc7404b48c14c1fb77f74840{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-km3mpozn-7a5f7920dc7404b48c14c1fb77f74840 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-km3mpozn-7a5f7920dc7404b48c14c1fb77f74840 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div class=\"av-special-heading av-km3mpozn-7a5f7920dc7404b48c14c1fb77f74840 av-special-heading-h3 blockquote modern-quote  avia-builder-el-51  el_after_av_heading  el_before_av_textblock \"><h3 class=\"av-special-heading-tag \" itemprop=\"headline\">Second concept paper from the ISPE GAMP R&amp;D and Clinical Systems SIG<\/h3><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>[2 October 2014] The Good Clinical Practice (GCP) fields is undergoing many changes: for example, the publication of a new EU regulation on clinical trials (&ldquo;Clinical Trials Regulation&rdquo;) was announced for 2014, the aim of which is to make the planning, approval and execution of clinical trials in the EU more efficient. Computerized systems make a significant contribution to increasing efficiency. The ISPE GAMP R&amp;D and Clinical Systems SIG has published another concept paper entitled &ldquo;Validation 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> in eClinical Platforms&rdquo;.<\/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-5ay7t9-8fba289bb5addf7d7641848e003cc007\">\n.flex_column.av-5ay7t9-8fba289bb5addf7d7641848e003cc007{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-5ay7t9-8fba289bb5addf7d7641848e003cc007 av_one_half  avia-builder-el-53  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  \"><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n\n<\/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-kkzoo54d-b0d068eca6fe1f1c87db0ed1438583cf\">\n.avia-section.av-kkzoo54d-b0d068eca6fe1f1c87db0ed1438583cf{\nbackground-color:#ffffff;\nbackground-image:unset;\n}\n#top .avia-section.av-kkzoo54d-b0d068eca6fe1f1c87db0ed1438583cf .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-kkzoo54d-b0d068eca6fe1f1c87db0ed1438583cf .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_10\" class=\"avia-section av-kkzoo54d-b0d068eca6fe1f1c87db0ed1438583cf alternate_color avia-section-default avia-no-border-styling  avia-builder-el-54  el_after_av_section  el_before_av_section  avia-bg-style-fixed container_wrap fullsize\"><div class=\"av-section-color-overlay-wrap\"><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color 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sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-cz9x3h-3d850509c5b5240eeef4407c76f03e64\">\n.flex_column.av-cz9x3h-3d850509c5b5240eeef4407c76f03e64{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\nbackground-color:#ffffff;\n}\n<\/style>\n<div class=\"flex_column av-cz9x3h-3d850509c5b5240eeef4407c76f03e64 av_one_half  avia-builder-el-55  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-av7kul-b63ed8768901dc7e0bebd461d4bffbd8\">\n.flex_column.av-av7kul-b63ed8768901dc7e0bebd461d4bffbd8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\nbackground-color:#ffffff;\n}\n<\/style>\n<div class=\"flex_column av-av7kul-b63ed8768901dc7e0bebd461d4bffbd8 av_one_half  avia-builder-el-56  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab\">\n#top .av-special-heading.av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab{\npadding-bottom:10px;\ncolor:#ea5a0c;\nfont-size:50px;\n}\nbody .av-special-heading.av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab .special-heading-inner-border{\nborder-color:#ea5a0c;\n}\n.av-special-heading.av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab .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-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab .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-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-2y4e0x-7873fa61de5ea52fc0be73f2ec086cab av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-57  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">ISPE GAMP R&amp;D and Clinical Systems SIG publishes first Concept Paper<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kl0mtsgh-63bdb3d9c2d37498ed7f73f24bda06e3\">\n#top .av_textblock_section.av-kl0mtsgh-63bdb3d9c2d37498ed7f73f24bda06e3 .avia_textblock{\ncolor:#000000;\n}\n<\/style>\n<section class=\"av_textblock_section av-kl0mtsgh-63bdb3d9c2d37498ed7f73f24bda06e3 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><p>[7 October 2013] Due to the fact that the pharmaceutical industry is gradually switching from paper-based to electronically supported processes, the validation of computerized systems is increasingly becoming the focus of official inspections in the field of clinical studies as well. This means that there is an increased need for guidelines for GCP-regulated systems, especially since these play an important role in the life cycle of drugs. GCP experts from the R&amp;D and Clinical Systems SIG, led by the Q-FINITY CEO, prepared the concept paper with the intention of bringing the GAMP 5 principles into alignment with GCP requirements using the example of an Electronic <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> Capture System (EDC).<\/p>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n\n<\/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-kkzoo54d-65bdbe120344658efeaaab8c3404cff2\">\n.avia-section.av-kkzoo54d-65bdbe120344658efeaaab8c3404cff2 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-kkzoo54d-65bdbe120344658efeaaab8c3404cff2 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-kkzoo54d-65bdbe120344658efeaaab8c3404cff2 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_11\" class=\"avia-section av-kkzoo54d-65bdbe120344658efeaaab8c3404cff2 main_color avia-section-default avia-no-border-styling  avia-builder-el-59  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 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.av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-4ays8y-6885ef0b4aedd6e6df2b9e4b89293016 .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-4ays8y-6885ef0b4aedd6e6df2b9e4b89293016 .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-4ays8y-6885ef0b4aedd6e6df2b9e4b89293016 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-4ays8y-6885ef0b4aedd6e6df2b9e4b89293016 av-special-heading-h2 blockquote modern-quote  avia-builder-el-61  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-5dqix9-4a2360e949531b191c92e8a9972cd6eb\">\n.flex_column.av-5dqix9-4a2360e949531b191c92e8a9972cd6eb{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-5dqix9-4a2360e949531b191c92e8a9972cd6eb av_one_half  avia-builder-el-62  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-cs1bh-aedb06a96f591f88c33934693f6269f0\">\n.flex_column.av-cs1bh-aedb06a96f591f88c33934693f6269f0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-cs1bh-aedb06a96f591f88c33934693f6269f0 av_one_full  avia-builder-el-63  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-kl6bpo4l-3f6a1ae0377c20fca5bec6932561c4d3 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=\"4964\"><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-4octel-00d68aec5df48c771d12a1461a25c3e2\">\n.flex_column.av-4octel-00d68aec5df48c771d12a1461a25c3e2{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-4octel-00d68aec5df48c771d12a1461a25c3e2 av_one_half  avia-builder-el-65  el_after_av_one_full  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><div class=\"avia-buttonrow-wrap av-kl0mkmfi-8591c666be3b80629658daea545b04fd avia-buttonrow-left  avia-builder-el-66  avia-builder-el-no-sibling \">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-364g5e-b18194277ec74580452872d53bdd0604\">\n#top #wrap_all .avia-button.av-364g5e-b18194277ec74580452872d53bdd0604{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-364g5e-b18194277ec74580452872d53bdd0604:hover{\ncolor:#ffffff;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-364g5e-b18194277ec74580452872d53bdd0604:hover .avia-svg-icon svg:first-child{\nfill:#ffffff;\nstroke:#ffffff;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-364g5e-b18194277ec74580452872d53bdd0604 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><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2etae5-61081d9fa79fe13b8dab197a76aecf87\">\n.flex_column.av-2etae5-61081d9fa79fe13b8dab197a76aecf87{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-2etae5-61081d9fa79fe13b8dab197a76aecf87 av_one_half  avia-builder-el-67  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-kl0mz7iy-40ceb462fa1785e2c5a1e6ce0c76e83c\">\n#top .hr.hr-invisible.av-kl0mz7iy-40ceb462fa1785e2c5a1e6ce0c76e83c{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-kl0mz7iy-40ceb462fa1785e2c5a1e6ce0c76e83c hr-invisible  avia-builder-el-68  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":5430,"parent":4909,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4964","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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