{"id":3645,"date":"2022-09-15T09:34:59","date_gmt":"2022-09-15T08:34:59","guid":{"rendered":"https:\/\/evaluconseil.com\/whats-new-on-the-gamp-5-2nd-edition\/"},"modified":"2025-02-25T14:12:49","modified_gmt":"2025-02-25T13:12:49","slug":"whats-new-on-the-gamp-5-2nd-edition","status":"publish","type":"post","link":"https:\/\/evaluconseil.com\/en\/whats-new-on-the-gamp-5-2nd-edition\/","title":{"rendered":"What&#8217;s new on the GAMP 5 2nd edition?"},"content":{"rendered":"<p class=\"has-medium-font-size\">In the summer of 2022, the second edition of the GAMP 5 of the ISPE was released, Evalu presents you the main lines.<\/p>\n<p class=\"has-medium-font-size\"><strong>What is GAMP 5?<\/strong><\/p>\n<p class=\"has-small-font-size\">GAMP 5, released in 2008, is not a regulatory text, but a best practice guide to meet regulations concerning <strong>the validation, design and development of computerized and automated systems. <\/strong>Version 5 of GAMP takes a fresh look at user\/supplier relationships and qualifications, as well as the notion of risk analysis.<\/p>\n<p class=\"has-small-font-size\">In the second version of the guide, the importance of critical thinking is emphasized. In addition, this edition remains patient-focused and promotes innovation while remaining compliant with regulations, all in a pragmatic manner.<\/p>\n<p class=\"has-medium-font-size\"><strong>GAMP Challenges 5 Ed 2&nbsp;:<\/strong><\/p>\n<ul class=\"has-small-font-size\">\n<li>Supporting innovation with the objective of ensuring product and patient safety and data integrity<\/li>\n<li>Save time and have less rigid and more efficient approaches (importance of critical thinking)<\/li>\n<\/ul>\n<p class=\"has-medium-font-size\"><strong>Topics addressed by GAMP 5 Ed 2&nbsp;:<\/strong><\/p>\n<p class=\"has-small-font-size\">Importance of service providers, including encouraging regulated companies to maximize provider participation to leverage knowledge, experience and documentation to the extent possible.<\/p>\n<p class=\"has-small-font-size\">Consideration of agile software development methodologies, emphasizing that the GAMP specification and verification approach is not inherently linear but perhaps incremental.<\/p>\n<p class=\"has-small-font-size\">Use of automation tools to achieve better control, better quality and shorter lead times throughout the project.<\/p>\n<p class=\"has-small-font-size\">Taking into account new technologies such as blockchain, openchain, &#8230;<\/p>\n<p class=\"has-small-font-size\">Propose an approach that can also meet other requirements including Sarbanes-Oxley for finance and RGPD for personal data.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the summer of 2022, the second edition of the GAMP 5 of the ISPE was released, Evalu presents you the main lines. What is GAMP 5? GAMP 5, released in 2008, is not a regulatory text, but a best practice guide to meet regulations concerning the validation, design and development of computerized and automated [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3652,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[17],"tags":[],"class_list":["post-3645","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>What&#039;s new on the GAMP 5 2nd edition? - Evalu<\/title>\n<meta name=\"description\" content=\"In the summer of 2022, the second edition of the GAMP 5 of the ISPE was released, Evalu presents you the main lines.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/evaluconseil.com\/en\/whats-new-on-the-gamp-5-2nd-edition\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What&#039;s new on the GAMP 5 2nd edition? - Evalu\" \/>\n<meta property=\"og:description\" content=\"In the summer of 2022, the second edition of the GAMP 5 of the ISPE was released, Evalu presents you the main lines.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/evaluconseil.com\/en\/whats-new-on-the-gamp-5-2nd-edition\/\" \/>\n<meta property=\"og:site_name\" content=\"Evalu\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-15T08:34:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-25T13:12:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/evaluconseil.com\/wp-content\/uploads\/2022\/09\/MicrosoftTeams-image-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"260\" \/>\n\t<meta property=\"og:image:height\" content=\"337\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Oriana Branchflower\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Oriana Branchflower\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/whats-new-on-the-gamp-5-2nd-edition\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/whats-new-on-the-gamp-5-2nd-edition\\\/\"},\"author\":{\"name\":\"Oriana Branchflower\",\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/#\\\/schema\\\/person\\\/eb816738b1d0b427274149ab906b1ac6\"},\"headline\":\"What&#8217;s new on the GAMP 5 2nd edition?\",\"datePublished\":\"2022-09-15T08:34:59+00:00\",\"dateModified\":\"2025-02-25T13:12:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/whats-new-on-the-gamp-5-2nd-edition\\\/\"},\"wordCount\":238,\"publisher\":{\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/whats-new-on-the-gamp-5-2nd-edition\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/evaluconseil.com\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/MicrosoftTeams-image-1.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/whats-new-on-the-gamp-5-2nd-edition\\\/\",\"url\":\"https:\\\/\\\/evaluconseil.com\\\/en\\\/whats-new-on-the-gamp-5-2nd-edition\\\/\",\"name\":\"What's new on the GAMP 5 2nd edition? 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