{"id":13160,"date":"2024-07-08T19:18:58","date_gmt":"2024-07-08T17:18:58","guid":{"rendered":"https:\/\/q-finity.de\/?page_id=13160"},"modified":"2024-07-08T19:18:58","modified_gmt":"2024-07-08T17:18:58","slug":"computer-software-assurance","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/computer-software-assurance\/","title":{"rendered":"Computer Software Assurance"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd7g988-b626bffdb0c6d83d5f9b6eb55bf00991\">\n.avia-section.av-lyd7g988-b626bffdb0c6d83d5f9b6eb55bf00991{\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_methode_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id=\"av_section_1\" class=\"avia-section av-lyd7g988-b626bffdb0c6d83d5f9b6eb55bf00991 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll 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=\"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-13160\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd7d5ig-67ac97c2602b7507e501e19beabcc207\">\n#top .av-special-heading.av-lyd7d5ig-67ac97c2602b7507e501e19beabcc207{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lyd7d5ig-67ac97c2602b7507e501e19beabcc207 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd7d5ig-67ac97c2602b7507e501e19beabcc207 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd7d5ig-67ac97c2602b7507e501e19beabcc207 .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-lyd7d5ig-67ac97c2602b7507e501e19beabcc207 .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-lyd7d5ig-67ac97c2602b7507e501e19beabcc207 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-lyd7d5ig-67ac97c2602b7507e501e19beabcc207 av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-1  avia-builder-el-no-sibling  av-inherit-size\"><h1 class=\"av-special-heading-tag \" itemprop=\"headline\">Computer Software Assurance <\/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 id=\"av_section_2\" class=\"avia-section av-lyd86hpz-2de723efb1ad5e26a281607ea54f70e7 main_color avia-section-default avia-no-border-styling  avia-builder-el-2  el_after_av_section  el_before_av_section  avia-bg-style-fixed 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-13160\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-3  avia-builder-el-no-sibling  first flex_column_div  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d\">\n#top .av-special-heading.av-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d .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-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d .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-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lyd7ibks-c4fc0742da85ee156929fe2093e1df8d 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\">Consistent application of the risk-based approach<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lyd7jns4-39891ab8ec0bc56702a7f297e03f3996 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>Even today, systems are still only subjected to an inadequate risk assessment and all functions are tested and documented without taking the risk into account. In some companies, this has led to a hesitant introduction of new systems, as the validation effort is considered too high and the value of validation too low. The digitalization of the life science sector has therefore progressed more slowly than in other industries. The responsible authority in the USA (FDA) then developed the <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> Software Assurance approach with industry experts in order to reduce these hurdles without compromising on <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> assurance. GAMP 5 and ICH guidelines have also long called for a risk-based approach that allows validation efforts to be scaled and focused on higher risk areas.<\/p>\n<p><a href=\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\" target=\"_self\" title=\"The CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested. High-Risk functions should be tested more extensively with higher control in a fully scripted test. Low risk functions can be tested more informally with minimal documentation. The basis for the CSA&hellip;\" class=\"encyclopedia\">Computer Software Assurance (CSA)<\/a> is a modern approach to software <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> assurance that focuses on <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> processes and the management of risk to ensure the reliability and safety of <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> software in regulated environments, such as the pharmaceutical and medical device industries. Unlike traditional methods that rely heavily on extensive documentation and formal validation processes, CSA promotes more efficient testing and evaluation of software by prioritizing risk assessment and management. This approach allows organizations to focus on the aspects that are most important to product <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a>, patient safety 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> security, while reducing compliance costs and accelerating innovation.<\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd7nk0u-684149e9a4b77543b159481392bd54ca\">\n.avia-section.av-lyd7nk0u-684149e9a4b77543b159481392bd54ca{\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_methode_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_3\" class=\"avia-section av-lyd7nk0u-684149e9a4b77543b159481392bd54ca alternate_color avia-section-default avia-no-border-styling  avia-builder-el-6  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=\"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-13160\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-7  el_before_av_one_half  avia-builder-el-first  first flex_column_div  \"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa 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-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4\">\n#top .av-special-heading.av-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4{\npadding-bottom:10px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lyd7mmda-8cf9d371d7df53e117a5cfa6ccdf72f4 av-special-heading-h2 custom-color-heading  avia-builder-el-9  el_before_av_textblock  avia-builder-el-first \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">QFINITY&infin; SUPPORTS THE CSA APPROACH TO VALIDATION IN PARTICULAR THROUGH THE FOLLOWING SERVICES:<\/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-lyd7rgf8-ed1a7b4fb40cdcff8c46c4a28ff67bfd\">\n#top .av_textblock_section.av-lyd7rgf8-ed1a7b4fb40cdcff8c46c4a28ff67bfd .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section class=\"av_textblock_section av-lyd7rgf8-ed1a7b4fb40cdcff8c46c4a28ff67bfd \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock av_inherit_color\" itemprop=\"text\"><ul>\n<li>Risk assessment and management based on intended use\/ intended purpose<\/li>\n<li>Development of risk-based test strategies<\/li>\n<li>Risk-based reduction of documentation efforts<\/li>\n<li>Introduction of agile methods in line with CSA approaches<\/li>\n<li>Optimization of software development and maintenance processes<\/li>\n<li>Customized training and workshops on CSA principles and risk management<\/li>\n<li>Adaptation of validation processes with regard to the CSA approach<\/li>\n<\/ul>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd888gz-fced7104fc8e0f829ff7fa4f788faf96\">\n.avia-section.av-lyd888gz-fced7104fc8e0f829ff7fa4f788faf96{\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_methode_black.svg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_4\" class=\"avia-section av-lyd888gz-fced7104fc8e0f829ff7fa4f788faf96 main_color avia-section-default avia-no-border-styling  avia-builder-el-11  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=\"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-13160\"><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-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9\">\n#top .av-special-heading.av-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9 .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-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9 .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-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lyd7trxd-fa7e5a24e0f722e8533a7e6baf5988f9 av-special-heading-h2 blockquote modern-quote  avia-builder-el-13  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Computer Software Assurance for high-performance software<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lyd7ufm2-6b6a0dc0b67df9f692759d33ab676867 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>The most important steps of <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> Software Assurance are defined:<\/p>\n<\/div><\/section><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd7xz8q-643bb4d297783d05d0f2c55d804df1d9\">\n#top .avia-icon-list-container.av-lyd7xz8q-643bb4d297783d05d0f2c55d804df1d9 .iconlist_icon{\ncolor:#ea5a0c;\n}\n#top .avia-icon-list-container.av-lyd7xz8q-643bb4d297783d05d0f2c55d804df1d9 .iconlist_icon svg:first-child{\nstroke:#ea5a0c;\nfill:#ea5a0c;\n}\n<\/style>\n<div class=\"avia-icon-list-container av-lyd7xz8q-643bb4d297783d05d0f2c55d804df1d9  avia-builder-el-15  el_after_av_textblock  el_before_av_textblock \"><ul class=\"avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-small av-lyd7xz8q-643bb4d297783d05d0f2c55d804df1d9 avia-iconlist-animate\">\n<li><div class=\"iconlist_icon av-lyd7wc7m-b0b0e65aa851849ca193ce65d47e9b3d avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Intended use: Clear outline of the intended purpose and initial risk assessment\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Intended use: Clear outline of the intended purpose and initial risk assessment<\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-lyd7wv46-06792450e15f48c90a576a80d1d22725 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Consistent application of the risk-based approach for sub-areas and functions of the software\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Consistent application of the risk-based approach for sub-areas and functions of the software<\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-lyd7xdr1-d4e55a91bd4cecda47f31cac9107e977 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Determining the appropriate test approach based on the identified risk\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Determining the appropriate test approach based on the identified risk<\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-lyd7xxn4-12f538fb9714af60daee2851c82f8498 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Selection of a suitable documentation approach that also saves time and resources\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Selection of a suitable documentation approach that also saves time and resources<\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br>\n<section class=\"av_textblock_section av-lyd82cy3-b819b8256e70eb08a5ec9cb91d7928ee \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>It should be emphasized that CSA does not replace the known validation approaches described in GAMP5&reg;, PICs or EU-GMP Annex 11, but complements them. The CSA approach is primarily aimed at testing the software within the <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together&hellip;\" class=\"encyclopedia\">computerized system<\/a> and therefore does not cover all aspects of the <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together&hellip;\" class=\"encyclopedia\">computerized system<\/a>. This differentiation is not insignificant: a <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together&hellip;\" class=\"encyclopedia\">computerized system<\/a> always includes the business processes, the user, the documentation and the operating environment of the system. A <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> system, and the associated testing, is therefore only one component of the broader concept of a <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together&hellip;\" class=\"encyclopedia\">computerized system<\/a> in the holistic validation approach, as described in GAMP 5.<\/p>\n<p>The CSA <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>, on the other hand, is primarily aimed at the group of software developers and software <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> assurance (SQA) specialists. Although <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> Software Assurance is a consistent application of the established GAMP&reg; principles, it primarily looks at isolated software. The embedding of the software in the hardware environment or surrounding processes are not the direct focus of CSA, but depending on the individual system and scenarios, CSA approaches can also be applied in these areas.<\/p>\n<\/div><\/section><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-17  el_after_av_one_half  avia-builder-el-last  flex_column_div  \"><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd8btgr-a76d2dcc9bea46325dff91102943cd4c\">\n.avia-section.av-lyd8btgr-a76d2dcc9bea46325dff91102943cd4c{\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_methode_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_5\" class=\"avia-section av-lyd8btgr-a76d2dcc9bea46325dff91102943cd4c alternate_color avia-section-default avia-no-border-styling  avia-builder-el-18  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=\"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-13160\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-19  el_before_av_one_half  avia-builder-el-first  first flex_column_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-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389\">\n#top .av-special-heading.av-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:50px;\n}\nbody .av-special-heading.av-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 .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-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 .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-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-lyd8d5o4-b0d7bc20f7fb2ed91d370f9276c1d389 av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-21  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">QFINITY: Der Spezialist f&uuml;r Computer Software Assurance und vieles mehr<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-lyd8ds8u-f8685d7046704560cfb7376f0a113801 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>In the <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> software assurance approach, the consideration of the respective individual risks is focused on three areas:<\/p>\n<\/div><\/section><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd8h5c3-2cb599504a0494a33a4934a7d884e248\">\n#top .avia-icon-list-container.av-lyd8h5c3-2cb599504a0494a33a4934a7d884e248 .iconlist_icon{\ncolor:#ffffff;\n}\n#top .avia-icon-list-container.av-lyd8h5c3-2cb599504a0494a33a4934a7d884e248 .iconlist_icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div class=\"avia-icon-list-container av-lyd8h5c3-2cb599504a0494a33a4934a7d884e248  avia-builder-el-23  el_after_av_textblock  el_before_av_textblock \"><ul class=\"avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-small av-lyd8h5c3-2cb599504a0494a33a4934a7d884e248 avia-iconlist-animate\">\n<li><div class=\"iconlist_icon av-lyd8ffzd-11d196b2576cb20427744d103a134827 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risks for patients\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Risks for patients<\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-lyd8fyuy-c052d349c0acb991f77cb700eb22fa4a avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risks for product quality\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Risks for 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><\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-lyd8gflr-6b98c492de53cb66af8069ca6067a887 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59586;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Risks to data integrity\"><div class=\"av_iconlist_title iconlist_title_small  \" itemprop=\"headline\">Risks to <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><\/div><\/header><div class=\"iconlist_content \" itemprop=\"text\"><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><br>\n<section class=\"av_textblock_section av-lyd8itrh-3457b6285b6e10155e2f78ec3d1cde09 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>These and other relevant risk criteria are just some of the many reasons why only specialists should be trusted with the validation of relevant software areas. With its methodological competence and holistic approach, <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> has developed outstanding expertise in the past, including in the area of agile software development for innovative applications and cloud-based solutions. <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 innovative services link complex technologies with a consistent and efficient validation framework within the existing <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality-management\/\" target=\"_self\" title=\"Quality Management (QM) refers to all organizational measures that relate to the structure of the organization and the efficient execution of processes at various levels of the company. With consistent implementation, quality management enables the continuous improvement of corporate culture, process quality and technology deployment, ultimately leading to better products or services. If you need&hellip;\" class=\"encyclopedia\">quality management<\/a> system with processes, structures and specialist areas so that these can be mastered independently by the customer in the long term and permanently meet regulatory requirements.<\/p>\n<p>As a highly specialized management consultancy for risk-based <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>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> assurance, GxP compliance and continuous improvement of processes and computerized systems, <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 also the first point of contact for all aspects of <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> software assurance. The compliance consultancy for companies in the pharmaceutical and medical device industry and in the healthcare sector ensures holistic <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> and efficient production cycles for a steadily growing number of satisfied customers &ndash; over 140 from start-ups to SMEs and global corporations.<\/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 happy to support you in the development and introduction of risk-based <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>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> assurance of processes, <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. We offer you competent consulting services for the successful company of tomorrow &ndash; just get in touch with us!<\/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-lyd8scx0-66d85e1518566fb80e9f7bc5918d41ae\">\n.avia-section.av-lyd8scx0-66d85e1518566fb80e9f7bc5918d41ae{\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_methode_black.svg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n<\/style>\n<div id=\"av_section_6\" class=\"avia-section av-lyd8scx0-66d85e1518566fb80e9f7bc5918d41ae main_color avia-section-default avia-no-border-styling  avia-builder-el-25  el_after_av_section  el_before_av_postcontent  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><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-13160\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-26  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-lyd8m18b-f02c5504bda444db9c4289e4248c82c2\">\n#top .av-special-heading.av-lyd8m18b-f02c5504bda444db9c4289e4248c82c2{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-lyd8m18b-f02c5504bda444db9c4289e4248c82c2 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lyd8m18b-f02c5504bda444db9c4289e4248c82c2 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lyd8m18b-f02c5504bda444db9c4289e4248c82c2 .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-lyd8m18b-f02c5504bda444db9c4289e4248c82c2 .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-lyd8m18b-f02c5504bda444db9c4289e4248c82c2 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-lyd8m18b-f02c5504bda444db9c4289e4248c82c2 av-special-heading-h2 blockquote modern-quote  avia-builder-el-27  avia-builder-el-no-sibling  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">QUESTIONS?<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa av_one_half  avia-builder-el-28  el_after_av_one_half  el_before_av_one_half  flex_column_div  \"><\/div><div class=\"flex_column av-av_one_half-41ee899840124b6993b57a87f996c353 av_one_half  avia-builder-el-29  el_after_av_one_half  avia-builder-el-last  first flex_column_div  column-top-margin\"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lyd8qh7o-901a3f41996eefdca0bcddac61d97d90\">\n#top .togglecontainer.av-lyd8qh7o-901a3f41996eefdca0bcddac61d97d90 p.toggler{\nborder-color:#ea5a0c;\n}\n#top .togglecontainer.av-lyd8qh7o-901a3f41996eefdca0bcddac61d97d90 .toggle_wrap .toggle_content{\nborder-color:#ea5a0c;\n}\n<\/style>\n<div class=\"togglecontainer av-lyd8qh7o-901a3f41996eefdca0bcddac61d97d90 av-minimal-toggle  avia-builder-el-30  avia-builder-el-no-sibling  toggle_close_all\">\n<section class=\"av_toggle_section av-lyd8nhe9-b9362edfd632cf61b478d0c8580f7a0a\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"><p id=\"toggle-toggle-id-1\" data-fake-id=\"#toggle-id-1\" class=\"toggler  av-title-above av-inherit-border-color\" itemprop=\"headline\" role=\"tab\" tabindex=\"0\" aria-controls=\"toggle-id-1\" data-slide-speed=\"200\" data-title=\"What is Computer Software Assurance?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What is Computer Software Assurance?\" data-aria_expanded=\"Click to collapse: What is Computer Software Assurance?\">What is <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> Software Assurance?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id=\"toggle-id-1\" aria-labelledby=\"toggle-toggle-id-1\" role=\"region\" class=\"toggle_wrap  av-title-above\"><div class=\"toggle_content invers-color av-inherit-border-color\" itemprop=\"text\"><p><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> Software Assurance is an approach developed based on the traditional validation approach to achieve an efficient balance between testing activities and documentation requirements in the context of the development and validation of software for or in the pharmaceutical, medical device and healthcare industries.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class=\"av_toggle_section av-lyd8o85e-a00d170bc342d20a63e936735d7360b6\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"><p id=\"toggle-toggle-id-2\" data-fake-id=\"#toggle-id-2\" class=\"toggler  av-title-above av-inherit-border-color\" itemprop=\"headline\" role=\"tab\" tabindex=\"0\" aria-controls=\"toggle-id-2\" data-slide-speed=\"200\" data-title=\"What characterizes the Computer Software Assurance of the specialist QFINITY?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What characterizes the Computer Software Assurance of the specialist QFINITY?\" data-aria_expanded=\"Click to collapse: What characterizes the Computer Software Assurance of the specialist QFINITY?\">What characterizes the <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> Software Assurance of the specialist <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>?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id=\"toggle-id-2\" aria-labelledby=\"toggle-toggle-id-2\" role=\"region\" class=\"toggle_wrap  av-title-above\"><div class=\"toggle_content invers-color av-inherit-border-color\" itemprop=\"text\"><p><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> Software Assurance from <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>, like all of the specialist&rsquo;s services, is characterized by expertise, tailor-made solutions and innovative industry know-how, based on a customer base of more than 140 customers from the regulated environment.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class=\"av_toggle_section av-lyd8pffz-7754954b3908c45e940cc84221b9d932\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"><p id=\"toggle-toggle-id-3\" data-fake-id=\"#toggle-id-3\" class=\"toggler  av-title-above av-inherit-border-color\" itemprop=\"headline\" role=\"tab\" tabindex=\"0\" aria-controls=\"toggle-id-3\" data-slide-speed=\"200\" data-title=\"What is the significance of Computer Software Assurance for the medical technology \/ pharmaceutical industry? \" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What is the significance of Computer Software Assurance for the medical technology \/ pharmaceutical industry? \" data-aria_expanded=\"Click to collapse: What is the significance of Computer Software Assurance for the medical technology \/ pharmaceutical industry? \">What is the significance of <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> Software Assurance for the medical technology \/ pharmaceutical industry? <span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id=\"toggle-id-3\" aria-labelledby=\"toggle-toggle-id-3\" role=\"region\" class=\"toggle_wrap  av-title-above\"><div class=\"toggle_content invers-color av-inherit-border-color\" itemprop=\"text\"><p><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> Software Assurance ensures the smooth functionality of all relevant processes relating to the use and validation of complex software applications through extended risk-based testing activities while reducing the amount of documentation required.<\/p>\n<\/div><\/div><\/div><\/section>\n<\/div><\/div>[av_section min_height='100' min_height_pc='25' min_height_px='500px' shadow='no-border-styling' bottom_border='no-border-styling' bottom_border_diagonal_color='#ffffff' bottom_border_diagonal_direction='border-extra-diagonal-inverse' bottom_border_style='' padding='default' custom_margin='0px' custom_margin_sync='true' av-desktop-custom_margin='' av-desktop-custom_margin_sync='true' av-medium-custom_margin='' av-medium-custom_margin_sync='true' av-small-custom_margin='' av-small-custom_margin_sync='true' av-mini-custom_margin='' av-mini-custom_margin_sync='true' svg_div_top='' 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custom_width='50px' custom_margin_top='30px' custom_margin_bottom='30px' custom_border_color='' custom_icon_color='' id='' custom_class='' av_uid='av-2e70ka' admin_preview_bg='']\r\n[\/av_section]\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-8a7de07b8433181ed69a9d1a31092d4a\">\n.avia-section.av-av_section-8a7de07b8433181ed69a9d1a31092d4a .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-av_section-8a7de07b8433181ed69a9d1a31092d4a .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-av_section-8a7de07b8433181ed69a9d1a31092d4a .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_7\" class=\"avia-section av-av_section-8a7de07b8433181ed69a9d1a31092d4a main_color avia-section-default avia-no-border-styling  avia-builder-el-32  el_after_av_postcontent  avia-builder-el-last  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 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\"><div class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-13160\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-79ff81c021393065cee878051452f6a6\">\n.flex_column.av-av_one_half-79ff81c021393065cee878051452f6a6{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-79ff81c021393065cee878051452f6a6 av_one_half  avia-builder-el-33  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-953cfd6d800c7b5f931e3c8722dd8b39\">\n#top .av-special-heading.av-av_heading-953cfd6d800c7b5f931e3c8722dd8b39{\npadding-bottom:30px;\nfont-size:50px;\n}\nbody .av-special-heading.av-av_heading-953cfd6d800c7b5f931e3c8722dd8b39 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-av_heading-953cfd6d800c7b5f931e3c8722dd8b39 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-av_heading-953cfd6d800c7b5f931e3c8722dd8b39 .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-av_heading-953cfd6d800c7b5f931e3c8722dd8b39 .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-av_heading-953cfd6d800c7b5f931e3c8722dd8b39 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-av_heading-953cfd6d800c7b5f931e3c8722dd8b39 av-special-heading-h2 blockquote modern-quote  avia-builder-el-34  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-av_one_half-49f6e875884219cf77c24341e550af53\">\n.flex_column.av-av_one_half-49f6e875884219cf77c24341e550af53{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-49f6e875884219cf77c24341e550af53 av_one_half  avia-builder-el-35  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-av_one_full-79ff81c021393065cee878051452f6a6\">\n.flex_column.av-av_one_full-79ff81c021393065cee878051452f6a6{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_full-79ff81c021393065cee878051452f6a6 av_one_full  avia-builder-el-36  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-av_masonry_entries-29157dd713ef718f539eff79bdefee47 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=\"13160\"><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-av_one_half-79ff81c021393065cee878051452f6a6\">\n.flex_column.av-av_one_half-79ff81c021393065cee878051452f6a6{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-79ff81c021393065cee878051452f6a6 av_one_half  avia-builder-el-38  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-av_buttonrow-f06506bd62625c016b7f1c82f8f8b411 avia-buttonrow-left  avia-builder-el-39  avia-builder-el-no-sibling \">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_buttonrow_item-3906e56fd07c2878324547605ba0a0b6\">\n#top #wrap_all .avia-button.av-av_buttonrow_item-3906e56fd07c2878324547605ba0a0b6{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-av_buttonrow_item-3906e56fd07c2878324547605ba0a0b6:hover{\ncolor:#ffffff;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-av_buttonrow_item-3906e56fd07c2878324547605ba0a0b6:hover .avia-svg-icon svg:first-child{\nfill:#ffffff;\nstroke:#ffffff;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-av_buttonrow_item-3906e56fd07c2878324547605ba0a0b6 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=\"Zu unseren News\"><span class=\"avia_iconbox_title\">Zu unseren 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-av_one_half-49f6e875884219cf77c24341e550af53\">\n.flex_column.av-av_one_half-49f6e875884219cf77c24341e550af53{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-av_one_half-49f6e875884219cf77c24341e550af53 av_one_half  avia-builder-el-40  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin\"><\/div>\n\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-13160","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - 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