{"id":169172,"date":"2022-08-22T12:34:51","date_gmt":"2022-08-22T16:34:51","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/?p=169172"},"modified":"2025-06-21T17:53:17","modified_gmt":"2025-06-21T21:53:17","slug":"whats-new-in-gamp5-edition","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/whats-new-in-gamp5-edition\/","title":{"rendered":"What&#8217;s New in GAMP5 Edition 2?"},"content":{"rendered":"\n<p>It\u2019s here, it\u2019s here!&nbsp; I\u2019ve felt like Navin R. Johnson waiting for the new phone book to arrive.&nbsp; (You might have to Google this one if you\u2019re under age 50.)&nbsp; The Second Edition of GAMP5 is out!&nbsp; My colleagues and I have had a chance to review and will be writing a few articles describing the major changes and how the regulated community might benefit from the application of this new guidance.&nbsp; In this series of articles, we will touch on the following topics:<\/p>\n<ul>\n<li>Computer Software Assurance (CSA)<\/li>\n<li>Use of Agile and other non-linear lifecycle models<\/li>\n<li>Increasing use of cloud technologies such as Software-as-a-Service (SaaS)<\/li>\n<li>Use of Artificial Intelligence (AI) and Machine Learning (ML)<\/li>\n<\/ul>\n<p>In the meantime, I thought I\u2019d quickly introduce you to one of the more subtle changes we encountered when poring through our crisp new copy of Edition Two. And that change is \u2013 &nbsp;the renaming of GAMP5 Software Category 3 from \u201cNon-configured\u201d software product to \u201cStandard\u201d software product.&nbsp; At first glance, this is a subtle change.&nbsp; However, this simple change could serve as a respite for frustrated validation engineers everywhere.<\/p>\n<p>I was not in the room where it happened, but I am somewhat confident that at least one purpose of this change was to ward off the strict application of the word \u201cnon-configured.\u201d&nbsp; It has always been my interpretation that a software product is characterized as GAMP5 category 4 versus 3 when the product is configured to support the regulated company\u2019s business process.&nbsp; It has also been my understanding that a GAMP5 category 3 product could still require some configuration, but it shouldn\u2019t require configuration to conform to a specific business process.&nbsp; Even though a clarification was made in GAMP5 Edition 1, I have witnessed the literal interpretation of the word \u201cnon-configured\u201d and the creation of functional and configuration specification documents to contain a single alarm setpoint for a chart recorder.&nbsp;<\/p>\n<p>The given example is an extreme one, but cases just like this have occurred when organizations have applied the word \u201cnon-configured\u201d precisely.&nbsp; With the clarification that a software product can include limited configurations of parameterized values and still fall under the GAMP5 category 3 umbrella, hopefully, the industry can welcome flexibility in this instance without sacrificing patient safety, product quality, or data integrity.<\/p>\n<p>As always, it is important to remember that any risk-based decision should be anchored in science and the application of critical thinking to product and process knowledge.&nbsp; If you\u2019d like to discuss the nuances of GAMP5 software categorization or any other GAMP5 topic, reach out to me or one of my CAI colleagues.<\/p>\n<hr>\n<p>&nbsp;<\/p>\n\n\n\n<p><strong>About the Author:<\/strong><\/p>\n<div class=\"wp-block-image\">\n<figure class=\"alignleft size-full\"><img decoding=\"async\" class=\"aligncenter wp-image-1598 size-full\" src=\"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2014\/10\/CollierEric.jpg\" alt=\"\" width=\"90\" height=\"120\" \/><\/figure>\n<\/div>\n<p><strong>Eric S. Collier, Assistant Director, Automation and IT<br \/><\/strong>Eric has more than 30 years of experience as a project manager and software engineer providing best-in-class services and products to regulated industry in the areas of automation, manufacturing intelligence, computerized system validation, electronic records and signatures, and data integrity.<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":15,"featured_media":169173,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[145,261],"tags":[],"resource-featured-status":[],"resource-type":[819],"class_list":["post-169172","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-automation-automation-and-information-technologies","category-cgmp","resource-type-blog"],"acf":[],"featured_image_src":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2022\/08\/Banner-Business-Man-Signing-Contract-Teal.jpeg","featured_image_src_square":"https:\/\/caiready.com\/life-sciences\/wp-content\/uploads\/sites\/2\/2022\/08\/Banner-Business-Man-Signing-Contract-Teal.jpeg","author_info":{"display_name":"","author_link":"https:\/\/caiready.com\/life-sciences\/blog\/author\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/169172","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/comments?post=169172"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/169172\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media\/169173"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=169172"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=169172"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/tags?post=169172"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=169172"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=169172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}