{"id":350,"date":"2022-12-28T23:50:18","date_gmt":"2022-12-29T04:50:18","guid":{"rendered":"https:\/\/mivado.com\/mgp\/?page_id=350"},"modified":"2026-01-15T22:30:27","modified_gmt":"2026-01-16T03:30:27","slug":"validation-by-design","status":"publish","type":"page","link":"https:\/\/mivado.com\/mgp\/solutions\/validation-by-design\/","title":{"rendered":"Validation by Design"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>Validation by Design, a.k.a Validation 4.0, transforms the way validation is traditionally performed. Applying Validation 4.0 (Validation by Design) will require adopting a new way of thinking and working, as the system requirements should be verified during its development, configuration, and implementation.<\/p>\r\n<p><!-- \/wp:post-content --><br \/><!-- wp:heading {\"level\":4} --><\/p>\r\n<h4 class=\"wp-block-heading\">The validation by design incorporates the Computer Software Assurance (CSA), which is a risk-based approach for establishing and maintaining confidence that the computer system is fit for its intended use.<\/h4>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_single_image image=&#8221;3795&#8243; img_size=&#8221;Large&#8221; alignment=&#8221;center&#8221; style=&#8221;vc_box_shadow&#8221; css=&#8221;&#8221;][\/vc_column][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>The Validation activities should take place through the process design and product development that establishes a correlation between the Definition of Requirements, Validation Process, and Data Lifecycle with a solid risk-based approach.<\/p>\r\n<!-- \/wp:heading -->\r\n<p><!-- wp:paragraph -->&#8220;The goal of Validation 4.0 is to develop a cohesive, harmonized, integrated, holistic, risk-based approach for process performance qualification incorporating computer system validation that builds on the Pharma 4.0\u2122 operating model and includes the holistic control strategy, digital maturity, and data integrity by design.&#8221;<\/p>\r\n<p>Mivado GlobalPerformance will apply its 3-Stages Approach to System Validation called Validation by Design:<\/p>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/3&#8243;][vc_custom_heading text=&#8221;Stage 1: Requirements Development &amp; Design&#8221; css=&#8221;&#8221;][vc_empty_space][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>This Stage 1 is based on product, process, and data flow understanding, including system classification, System boundary, critical quality attributes (CQAs), and relevant regulatory requirements:<\/p>\r\n<ul>\r\n<li>System requirements development<\/li>\r\n<li>Functional Requirement Specification<\/li>\r\n<li>Quality Risk Assessment<\/li>\r\n<li>Quality critical requirements<\/li>\r\n<li>Validation Planning phase deliverable<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_custom_heading text=&#8221;Stage 2: Performance Qualification &amp; Validation&#8221; css=&#8221;&#8221;][vc_empty_space height=&#8221;60px&#8221;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>In Stage 2, System knowledge and understanding, coupled with a risk-based approach, are the keys to determining if the system performs as expected:<\/p>\r\n<!-- wp:list {\"start\":1} -->\r\n<ul>\r\n<li>Data Flow and Data Integrity<\/li>\r\n<li>System knowledge and understanding<\/li>\r\n<li>Supplier Assessment Review<\/li>\r\n<li>Requirements Risk Assessment<\/li>\r\n<li>Access Control Strategy<\/li>\r\n<li>Qualification and Testing Documentation<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_custom_heading text=&#8221;Stage 3: Continued System Verification &amp; Validation&#8221; css=&#8221;&#8221;][vc_empty_space height=&#8221;60px&#8221;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>This stage 3 shall put in place all necessary activities that need to be executed throughout the operational life of the system to verify that it remains compliant with regulatory requirements:<\/p>\r\n<ul>\r\n<li><!-- \/wp:list -->\u00a0Re-qualification Policy<\/li>\r\n<li>System intended use<\/li>\r\n<li>System Preventive Maintenance Program<\/li>\r\n<li>Periodic Review<\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<p>To ensure that the products are fit for intended use, the company has to demonstrate in a documented form that the processes, methods, tests, activities, and equipment they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions. The validation activities have been categorized into the following parts:<\/p>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/3&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li><strong>Process Validation<\/strong><\/li>\r\n<li><strong>Cleaning Validation<\/strong><\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li><strong>Method Validation<\/strong><\/li>\r\n<li><strong>Computer System Validation (CSV)\/ Computer Software Assurance (CSA)<\/strong><\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<ul>\r\n<li><strong>Facility, Utilities, Systems &amp; Equipment Validation<\/strong><\/li>\r\n<li><strong>Transportation Validation<\/strong><\/li>\r\n<\/ul>\r\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_cta h2=&#8221;Contact Mivado GlobalPerformance today to implement Validation by Design&#8221; color=&#8221;peacoc&#8221; add_button=&#8221;bottom&#8221; btn_title=&#8221;Send a Request Now!&#8221; btn_color=&#8221;warning&#8221; css_animation=&#8221;zoomIn&#8221; css=&#8221;.vc_custom_1768534222040{background-color: #D5CCCC !important;}&#8221; btn_link=&#8221;url:https%3A%2F%2Fmivado.com%2Fmgp%2Fcontact%2F&#8221;]<\/p>\r\n<div class=\"relative\">\r\n<div class=\"prose text-pretty dark:prose-invert inline leading-normal break-words min-w-0 [word-break:break-word] prose-strong:font-medium\">\r\n<p class=\"my-0 py-2 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\"><a href=\"https:\/\/mivado.com\/mgp\/contact\/\">Contact<\/a> Mivado GlobalPerformance today to implement Validation by Design and elevate your organization\u2019s quality, compliance, and data integrity. Our expert team is ready to help you streamline validation processes, reduce risk, and ensure audit readiness with our industry-leading, risk-based approach. Take the next step toward operational excellence.<\/p>\r\n<p class=\"my-0 py-2 [&amp;_strong:has(+br)]:inline-block [&amp;_strong:has(+br)]:pb-2\"><strong>Reach out now to get started!<\/strong><\/p>\r\n<\/div>\r\n<\/div>\r\n<p>[\/vc_cta][\/vc_column][\/vc_row][vc_row][vc_column][vc_custom_heading text=&#8221;Awards &amp; Certifications&#8221; css=&#8221;&#8221;][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/3&#8243;][vc_column_text css=&#8221;&#8221;]<\/p>\r\n<h2 class=\"wp-block-heading\"><a style=\"font-size: 17px; font-weight: 400;\" href=\"https:\/\/mivado.com\/mgp\/pressrelease\/mivado-globalperformance-wins-top-pharmaceutical-consultant-award-2024\/\"><img loading=\"lazy\" decoding=\"async\" width=\"624\" height=\"624\" class=\"wp-image-1859 aligncenter\" style=\"object-fit: contain; width: 194px; height: 194px;\" src=\"https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?resize=150%2C150&amp;ssl=1\" alt=\"\" srcset=\"https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?w=624&amp;ssl=1 624w, https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?resize=300%2C300&amp;ssl=1 300w, https:\/\/i0.wp.com\/mivado.com\/mgp\/wp-content\/uploads\/2024\/05\/badge_qualio-pharma-2024-1.png?resize=150%2C150&amp;ssl=1 150w\" sizes=\"auto, (max-width: 624px) 100vw, 624px\" \/><\/a><\/h2>\r\n<div class=\"wp-block-columns\"><!-- \/wp:paragraph --><br \/><!-- wp:column -->\r\n<div class=\"wp-block-column\">\u00a0<\/div>\r\n<p><!-- \/wp:column --><br \/><!-- wp:column --><\/p>\r\n<div class=\"wp-block-column\">\u00a0<\/div>\r\n<p><!-- \/wp:column --><\/p>\r\n<\/div>\r\n<p><!-- \/wp:columns -->[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/3&#8243;][\/vc_column][vc_column width=&#8221;1\/3&#8243;][\/vc_column][\/vc_row]<\/p><\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column width=&#8221;2\/3&#8243;][vc_column_text css=&#8221;&#8221;] Validation by Design, a.k.a Validation 4.0, transforms the way validation is traditionally performed. Applying Validation 4.0 (Validation by Design) will require adopting a new way of thinking and working, as the system requirements should be verified during its development, configuration, and implementation. The validation by design incorporates the Computer Software Assurance (CSA),<\/p>\n<div class=\"clearfix\"><\/div>\n<div class=\"pull-left padding-top-25\"><a href=\"https:\/\/mivado.com\/mgp\/solutions\/validation-by-design\/\" class=\"btn btn-theme\">Continue Reading <span class=\"screen-reader-text\"> &#8220;Validation by Design&#8221;<\/span> <i class=\"fa fa-fw fa-long-arrow-right\"><\/i> <\/a>  <\/div>\n","protected":false},"author":1,"featured_media":0,"parent":184,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template\/full-container.php","meta":{"footnotes":""},"class_list":["post-350","page","type-page","status-publish","hentry"],"wps_subtitle":"How to apply 3-Stage Approach to Industry 4.0","_links":{"self":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/350","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/comments?post=350"}],"version-history":[{"count":36,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/350\/revisions"}],"predecessor-version":[{"id":4303,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/350\/revisions\/4303"}],"up":[{"embeddable":true,"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/pages\/184"}],"wp:attachment":[{"href":"https:\/\/mivado.com\/mgp\/wp-json\/wp\/v2\/media?parent=350"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}