{"id":8570,"date":"2023-04-05T13:28:12","date_gmt":"2023-04-05T11:28:12","guid":{"rendered":"https:\/\/q-finity.de\/gamp-5-second-edition\/"},"modified":"2024-04-03T14:00:48","modified_gmt":"2024-04-03T12:00:48","slug":"gamp-5-second-edition","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/gamp-5-second-edition\/","title":{"rendered":"GAMP\u00ae 5 Second Edition"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgdqyhlb-67c68bec6c5b77c7fc645f9f40f4d2c7\">\n.avia-section.av-lgdqyhlb-67c68bec6c5b77c7fc645f9f40f4d2c7{\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_news_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-lgdqyhlb-67c68bec6c5b77c7fc645f9f40f4d2c7 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_hr  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-8570\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-av_one_full-a961ec8c42a44a397321d1a2224da3ca av_one_full  avia-builder-el-1  avia-builder-el-no-sibling  first flex_column_div  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgdrabbh-bad70d2219c882628964f6a68d62c781\">\n#top .av-special-heading.av-lgdrabbh-bad70d2219c882628964f6a68d62c781{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:50px;\n}\nbody .av-special-heading.av-lgdrabbh-bad70d2219c882628964f6a68d62c781 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lgdrabbh-bad70d2219c882628964f6a68d62c781 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-lgdrabbh-bad70d2219c882628964f6a68d62c781 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lgdrabbh-bad70d2219c882628964f6a68d62c781 .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-lgdrabbh-bad70d2219c882628964f6a68d62c781 .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-lgdrabbh-bad70d2219c882628964f6a68d62c781 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-lgdrabbh-bad70d2219c882628964f6a68d62c781 av-special-heading-h1 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-2  avia-builder-el-no-sibling  av-inherit-size\"><h1 class=\"av-special-heading-tag \" itemprop=\"headline\">GAMP&reg; 5 Second Edition<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<\/div><\/div><\/main><!-- close content main element --><\/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-8570\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l6eujc37-fbdbedd4ed20decfc050192c5008ebf9\">\n#top .hr.hr-invisible.av-l6eujc37-fbdbedd4ed20decfc050192c5008ebf9{\nheight:48px;\n}\n<\/style>\n<div class=\"hr av-l6eujc37-fbdbedd4ed20decfc050192c5008ebf9 hr-invisible  avia-builder-el-3  el_after_av_section  el_before_av_one_half  avia-builder-el-first \"><span class=\"hr-inner \"><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div class=\"flex_column av-8124c7-8fbea8c39de9a27735e4a522b010c175 av_one_half  avia-builder-el-4  el_after_av_hr  el_before_av_one_half  first flex_column_div  \"><section class=\"av_textblock_section av-l6etc7ln-8c258c2c800b86288b76ee22c801b64d \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>The <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a> community has just celebrated the 30th anniversary of the ISPE GAMP&reg; Guide and now we are excited about the release of GAMP&reg; 5 (Second Edition) in August 2022.<\/p>\n<p>The ISPE GAMP&reg; 5 Guide is considered the definitive guide to GxP compliance and computerized systems validation for companies and suppliers, and is referenced by regulatory agencies around the world. It provides a pragmatic and practical guide for industry to achieve compliant computerized systems suitable for their intended use in an efficient and effective manner. The flexible, risk-based approach to GxP-compliant computerized systems, based on scalable specification and verification, has proven effective for all types of systems, no matter how large or small.<\/p>\n<p>This edition retains the principles and framework of the First Edition, but has been updated and expanded to reflect the increasing importance of service providers, changing approaches to software development, and the widespread use of cloud technology, software tools, and automation. It emphasizes the need for <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> by knowledgeable and experienced experts to define appropriate approaches.<\/p>\n<\/div><\/section><\/div>\n<div class=\"flex_column av-5wh4sn-e72079a382acb4313f1ea8786c47b92c av_one_half  avia-builder-el-6  el_after_av_one_half  el_before_av_section  avia-builder-el-last  flex_column_div  \"><p><section class=\"av_textblock_section av-l6etciqq-d1b75e70f412cfc9ad8d11e0db06c64f \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>We are honored and proud to have been part of the GAMP&reg; 5 (Second Edition) Core Team and to have contributed to the creation and review of the guide. <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 been an active contributor within the ISPE GAMP community for many years and has contributed to ISPE Good Practice Guides such as &ldquo;Enabling Innovation&rdquo; and &ldquo;Validation and Compliance of Computerized GCP 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>&rdquo;. Now we add GAMP&reg; 5 (Second Edition) to this list.<\/p>\n<\/div><\/section><br>\n<section class=\"av_textblock_section av-245iev-370be3f205a5a547b1b38715cef1f9c2 \" 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> was part of the GAMP 5 (Second Edition) presentations at the ISPE Annual Meeting (2022) in Orlando and will be at the EU Annual Meeting 2023 in Amsterdam. We look forward to meeting you there.<\/p>\n<p><strong>However, if you have an urgent need for <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 expertise and services, please <a href=\"https:\/\/q-finity.de\/en\/contact\/?swcfpc=1\">contact<\/a> us.<\/strong><\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id=\"av_section_2\" class=\"avia-section av-3lv0w7-a266837f4269d941d6d7989815b7f4ec main_color avia-section-default avia-no-border-styling  avia-builder-el-9  el_after_av_one_half  el_before_av_postcontent  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-8570\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column av-32gakn-3ce493988300340fc09692778fb66683 av_one_full  avia-builder-el-10  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-l6eun11b-ca6d501693a670ce8738cf6e5ab49de8\">\n#top .av-special-heading.av-l6eun11b-ca6d501693a670ce8738cf6e5ab49de8{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-l6eun11b-ca6d501693a670ce8738cf6e5ab49de8 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-l6eun11b-ca6d501693a670ce8738cf6e5ab49de8 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div class=\"av-special-heading av-l6eun11b-ca6d501693a670ce8738cf6e5ab49de8 av-special-heading-h2 blockquote modern-quote modern-centered  avia-builder-el-11  avia-builder-el-no-sibling \"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">QFINITY is proud to have contributed to GAMP&reg; 5 (Second Edition)!<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div><div class=\"flex_column av-458omv-63711a4f8d1ef86d6de4a0041b75428b av_one_half  avia-builder-el-12  el_after_av_one_full  el_before_av_one_half  first flex_column_div  column-top-margin\"><p><section class=\"av_textblock_section av-l6etbe7j-44e84cee023af41f96c0d267b5b1f1e4 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>Highlights of the GAMP&reg; 5 (Second Edition) are:<\/p>\n<\/div><\/section><br>\n<\/p><div class=\"avia-icon-list-container av-l6uu88j1-2bcb77d92ea0c80ebaaf35922468e063  avia-builder-el-14  el_after_av_textblock  avia-builder-el-last \"><ul class=\"avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-l6uu88j1-2bcb77d92ea0c80ebaaf35922468e063 avia-iconlist-animate\">\n<li><div class=\"iconlist_icon av-l6uu2scs-ff03879c5af3f69f598c8f750875cea7 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59471;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Guide\"><h4 class=\"av_iconlist_title iconlist_title  \" itemprop=\"headline\">Guide<\/h4><\/header><div class=\"iconlist_content \" itemprop=\"text\"><p>for Blockchain Systems &amp; <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>.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-l6uu1avo-860878a7c566cc67c90ce5d3a35f5ebf avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Application\"><h4 class=\"av_iconlist_title iconlist_title  \" itemprop=\"headline\">Application<\/h4><\/header><div class=\"iconlist_content \" itemprop=\"text\"><p>from <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> to the validation of computerized systems<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-l6uu2dhi-c6d88824306280e8c127a07738d5ea53 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59553;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Validation\"><h4 class=\"av_iconlist_title iconlist_title  \" itemprop=\"headline\">Validation<\/h4><\/header><div class=\"iconlist_content \" itemprop=\"text\"><p>of systems with artificial intelligence and machine learning.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-l6uu3lp2-57754fb6f00086b5ea58fd2a8c224384 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59609;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Agile\"><h4 class=\"av_iconlist_title iconlist_title  \" itemprop=\"headline\">Agile<\/h4><\/header><div class=\"iconlist_content \" itemprop=\"text\"><p>Agile software development<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class=\"iconlist_icon av-l6uu3z0f-321ea9eab9c9c6f6c55d9c999f5881c6 avia-font-entypo-fontello avia-iconfont avia-font-entypo-fontello\"><span class=\"av-icon-char\" data-av_icon=\"&#59492;\" data-av_iconfont=\"entypo-fontello\" aria-hidden=\"true\"><\/span><\/div><article class=\"article-icon-entry \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: IT Service Management\"><h4 class=\"av_iconlist_title iconlist_title  \" itemprop=\"headline\">IT Service Management<\/h4><\/header><div class=\"iconlist_content \" itemprop=\"text\"><p>including cloud solutions (incl. SaaS validation)<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/div><div class=\"flex_column av-29hc9z-730e642799d8bd11e35a9bcd5ef6e78d av_one_half  avia-builder-el-15  el_after_av_one_half  el_before_av_hr  flex_column_div  column-top-margin\"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lgdr1l3h-c2d04d09ec017edf4c6e197feac300eb\">\n.avia-image-container.av-lgdr1l3h-c2d04d09ec017edf4c6e197feac300eb img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lgdr1l3h-c2d04d09ec017edf4c6e197feac300eb .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-lgdr1l3h-c2d04d09ec017edf4c6e197feac300eb 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=607976130  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-8709 avia-img-lazy-loading-not-8709 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1030\/h:773\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg\" alt=\"GAMP&reg; 5 Second Edition\" title=\"GAMP 5 Second Edition\" height=\"773\" width=\"1030\" itemprop=\"thumbnailUrl\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1030\/h:773\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 1030w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:225\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:576\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1440\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 1536w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1440\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 1500w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:529\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 705w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1440\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/04\/GAMP-5-Second-Edition.jpg 1600w\" sizes=\"(max-width: 1030px) 100vw, 1030px\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1v0ak7-5c22adcd9d8563c4e2cd312d7b0df711\">\n#top .hr.hr-invisible.av-1v0ak7-5c22adcd9d8563c4e2cd312d7b0df711{\nheight:48px;\n}\n<\/style>\n<div class=\"hr 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