{"id":6780,"date":"2019-05-09T00:00:00","date_gmt":"2019-05-09T00:00:00","guid":{"rendered":"https:\/\/slcontrols.com\/the-importance-of-change-management-in-validated-systems\/"},"modified":"2021-10-15T09:50:29","modified_gmt":"2021-10-15T09:50:29","slug":"the-importance-of-change-management-in-validated-systems","status":"publish","type":"post","link":"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/the-importance-of-change-management-in-validated-systems\/","title":{"rendered":"The Importance of Change Management in Validated Systems"},"content":{"rendered":"<p>Implementing change in a validated system is a crucial time for ensuring it remains controlled. As a result, it is essential that change management is carefully planned and implemented.<\/p>\n<p>This is particularly important for compliance reasons, not least because a carefully planned and documented change management process demonstrates to regulators that validated systems remain in a controlled and validated state after the changes take effect.<\/p>\n<h2>Categorising the Planned Change<\/h2>\n<p>Not all changes in validated systems are the same. For example, changes can be minor, or they can be complex and far-reaching.<\/p>\n<p>In manufacturing environments, you can normally categorise the changes being requested in three ways. By doing this, you can assess the resources you will need to successfully implement the change and ensure your processes and systems remain validated.<\/p>\n<p>The three main categories of change in a change management process are:<\/p>\n<ul>\n<li>Minor \u2013 minor changes require minimal testing to ensure re-validation. You can normally limit this testing to the specific element that is the main subject of the change.<\/li>\n<li>Major \u2013 major changes require more wide-ranging re-validation efforts. This often means testing and re-validating areas that are both directly and indirectly impacted by the change.<\/li>\n<li>Critical \u2013 critical changes typically involve re-validating the whole system. These are the most resource intensive and high-risk change management processes.<\/li>\n<\/ul>\n<h2>Do You Always Need to Re-Validate When a Change is Made?<\/h2>\n<p>Typically, yes, particularly in manufacturing environments that are heavily regulated such as in pharmaceuticals manufacturing and medical device manufacturing.<\/p>\n<p>The question is more about the scale of the re-validation effort that is required. In other words, is the change small and likely to have a minor impact? If so, minimal testing is required. For more substantial changes, however, further re-validation work up to full re-validation may be required.<\/p>\n<h2>Change Management Steps to Ensure Systems Remain Controlled and Validated<\/h2>\n<h3>Step 1 \u2013 Assess the Change Request<\/h3>\n<p>This includes assessing whether the change request is clear and whether the requirements and objectives of the change are well-defined. It\u2019s also important to assess whether the change request is justified, i.e. is it worth doing given the impact it could have on the already validated system.<\/p>\n<h3>Step 2 \u2013 Assess the Impact<\/h3>\n<p>You then need to assess the impact the change is likely to have on the controlled system. Often this involves conducting a risk assessment. A risk assessment will help to identify the parts of the system that require re-validation and new testing.<\/p>\n<h3>Step 3 \u2013 Document the Expected Outcomes<\/h3>\n<p>The risk assessment and analysis of the impact of the change will produce a set of expected outcomes. You should document these outcomes as part of the change management process.<\/p>\n<h3>Step 4 \u2013 Implement the Change in a Safe Environment<\/h3>\n<p>This could be a sandbox environment on a computer system, for example. If the change is being made to a manufacturing process, machine, or piece of equipment, the safe environment could be a digital twin. The safe environment could also be on a physical machine or manufacturing process while production is shut down.<\/p>\n<h3>Step 5 \u2013 Testing<\/h3>\n<p>Test the changes you have made and their impact on the system in the safe environment. This testing should be measured against the expected outcomes documented earlier. The results of the tests should be also be documented.<\/p>\n<h3>Step 6 &#8211; Implement the Changes in the Live Environment<\/h3>\n<p>Once you are happy with the results of testing in the safe environment, you can move to implementation in the live environment.<\/p>\n<h3>Step 7 &#8211; Testing and Re-Validation<\/h3>\n<p>Further testing and re-validation should take place with full records kept of all tests and test results.<\/p>\n<h3>Step 8 \u2013 Update Validation Documentation<\/h3>\n<p>The change you have implemented is likely to have made the existing validation documents out-of-date. You need to update these documents with the new information, specifications, processes, etc.<\/p>\n<h3><strong>Step 9 \u2013 Train Users<\/strong><\/h3>\n<p>Finally, it may be important to re-train users on how the changes implemented will affect them.<\/p>\n<h2>The Change Management Process<\/h2>\n<p>Ensuring your systems are validated during periods of change, however minor the change, requires careful planning and proper change management. This ensures ongoing regulatory compliance and makes the overall process more efficient.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Implementing change in a validated system is a crucial time for ensuring it remains controlled. As a result, it is essential that change management is carefully planned and implemented. This is particularly important for compliance reasons, not least because a carefully planned and documented change management process demonstrates to regulators that validated systems remain in &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/the-importance-of-change-management-in-validated-systems\/\"> <span class=\"screen-reader-text\">The Importance of Change Management in Validated Systems<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":24,"featured_media":2560,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"categories":[90],"tags":[],"class_list":["post-6780","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The Importance of Change Management in Validated Systems - SL Controls<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.stg.slcontrols.com.sq1.io\/the-importance-of-change-management-in-validated-systems\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The Importance of Change Management in Validated Systems - SL Controls\" \/>\n<meta property=\"og:description\" content=\"Implementing change in a validated system is a crucial time for ensuring it remains controlled. As a result, it is essential that change management is carefully planned and implemented. 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