{"id":10567,"date":"2021-10-04T09:09:22","date_gmt":"2021-10-04T07:09:22","guid":{"rendered":"https:\/\/www.s4bt.it\/change-control-digitisation\/"},"modified":"2021-12-03T11:43:07","modified_gmt":"2021-12-03T10:43:07","slug":"change-control-digitisation","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/change-control-digitisation\/","title":{"rendered":"The challenges of Change Control: sharing, documentation, training and digitisation"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10567\" class=\"elementor elementor-10567 elementor-1352\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-61a8f4c4 elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"61a8f4c4\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wider\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6aeaf268\" data-id=\"6aeaf268\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-29a1a2f7 elementor-widget elementor-widget-heading\" data-id=\"29a1a2f7\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">BLOG<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-744f4763 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"744f4763\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\" style=\"--divider-pattern-url: url(&quot;data:image\/svg+xml,%3Csvg xmlns=&#039;http:\/\/www.w3.org\/2000\/svg&#039; preserveAspectRatio=&#039;none&#039; overflow=&#039;visible&#039; height=&#039;100%&#039; viewBox=&#039;0 0 20 16&#039; fill=&#039;none&#039; stroke=&#039;black&#039; stroke-width=&#039;1&#039; stroke-linecap=&#039;square&#039; stroke-miterlimit=&#039;10&#039;%3E%3Cg transform=&#039;translate(-12.000000, 0)&#039;%3E%3Cpath d=&#039;M28,0L10,18&#039;\/%3E%3Cpath d=&#039;M18,0L0,18&#039;\/%3E%3Cpath d=&#039;M48,0L30,18&#039;\/%3E%3Cpath d=&#039;M38,0L20,18&#039;\/%3E%3C\/g%3E%3C\/svg%3E&quot;);\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3c49d0c2 elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"3c49d0c2\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">The challenges of Change Control: sharing, documentation, training and digitisation<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e64d945 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"3e64d945\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">The challenges of Change Control: sharing, documentation, training and digitisation<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b4c6391 elementor-widget elementor-widget-post-info\" data-id=\"3b4c6391\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-b0a0713 elementor-inline-item\" itemprop=\"author\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.s4bt.it\/en\/author\/silvia\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-user-circle\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author\">\n\t\t\t\t\t\t\t\t\t\tSilvia Di Gennaro\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-92e643a elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.s4bt.it\/en\/2021\/10\/04\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-calendar\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>04\/10\/2021<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-47bf436 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"47bf436\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-1c2b4ee2\" data-id=\"1c2b4ee2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-461ee815 elementor-widget elementor-widget-text-editor\" data-id=\"461ee815\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Change Control is a key system for ensuring the <strong>quality<\/strong> of products and processes, especially in the <strong>Life Sciences<\/strong> sector where there are significant <strong>regulatory<\/strong> complexities.<\/p><p>As defined in the <strong>EU GMP Guidelines<\/strong>, Change Control is a formal system whereby qualified representatives from appropriate disciplines review proposed or actual changes that could affect validation. Its aim is to determine whether action is needed to ensure that the overall system is maintained in its validated state.<\/p><h2 class=\"wp-block-spacer\" style=\"height: 100px;\" aria-hidden=\"true\"><span style=\"color: var( --e-global-color-secondary ); font-family: var( --e-global-typography-7eb7931-font-family ); font-size: var( --e-global-typography-7eb7931-font-size ); font-weight: var( --e-global-typography-7eb7931-font-weight ); letter-spacing: var( --e-global-typography-7eb7931-letter-spacing );\">Change requirements are company-wide<\/span><\/h2><p>Change requirements (Change Requests or COC) are not specific to one department, but can affect the whole company. Indeed, they are requested by those who need to implement a change that may impact validation.<\/p><p>When introducing a new line, for example, the Change Request is issued by the engineering and qualifications department and includes tasks for other departments, such as validation. For a change of material or supplier, on the other hand, the Change could be requested by the purchasing department.<\/p><p>Supervision is always carried out by the quality control department, which usually sets up a local and\/or global Change Control Committee, to which the most significant and relevant Change Controls are periodically presented, evaluated and discussed with the various impacted departments and where final authorisation is given.<\/p><div class=\"wp-block-media-text alignwide is-stacked-on-mobile\"><figure class=\"wp-block-media-text__media\"><\/figure><div class=\"wp-block-media-text__content\">\u00a0<\/div><\/div><h2>Documentation<\/h2><p class=\"wp-block-spacer\" style=\"height: 53px;\" aria-hidden=\"true\"><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">Each Change must be formally <\/span><strong style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">requested<\/strong><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">, <\/span><strong style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">documented<\/strong><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\"> and <\/span><strong style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">accepted<\/strong><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\"> by representatives from Production, QC\/QA, R&amp;D and Regulatory, as appropriate. The possible <\/span><br \/><strong style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">impact<\/strong><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\"> (risk assessment) of the change on the product must be <\/span><strong style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\">evaluated<\/strong><span style=\"font-size: 14px; color: var( --e-global-color-text ); letter-spacing: var( --e-global-typography-primary-letter-spacing );\"> and the necessity for and scope of the revalidation discussed. The Change Control system shall ensure that all notified or requested changes are satisfactorily investigated, documented and authorised (PIC\/S document PI 006, section 6.7.2).<\/span><\/p><p>The Change Control system requires a <strong>written procedure<\/strong> (change control program) to resolve the following points.<\/p><ul><li><p>Which types of change the Change Control system should take into account. To which sections these operating instructions apply.<\/p><\/li><li><p>Who can suggest\/initiate the Change.<\/p><\/li><li><p>How a change can be requested (form, digital system or other communication methods).<\/p><\/li><li><p>How changes are classified. Who is responsible for the evaluation.<\/p><\/li><li><p>How the measures necessary for implementing the change are determined and who compiles the required information.<\/p><\/li><li><p>Who is responsible for carrying out and monitoring all necessary measures.<\/p><\/li><li><p>How the Change Control Committee is assembled and which tasks it has.<\/p><\/li><li><p>How the change will be documented (format, content, memory).<\/p><\/li><li><p>Who is responsible for authorising the changes.<\/p><\/li><li><p>What are the special rules for urgent changes.<\/p><\/li><\/ul><h2>The challenges of Change Control<\/h2><p>The Change Control system is complex and therefore presents many challenges and difficulties. In particular:<\/p><ul><li><strong>Communication<\/strong>. Poor communication between departments, lack of follow up or escalation of change requests, delayed or inappropriate notification by suppliers, etc.<\/li><li><strong>Processing time<\/strong>. Many companies <strong>manually manage<\/strong> change requests and documentation. This causes a lot of effort, more management time and a higher risk of errors, backlog and loss of data and documents. <strong>Digitisation<\/strong> does not replace approvals and tasks, but simplifies compilation, information sharing and alerts on upcoming deadlines, thus increasing control of the process.<\/li><li><strong>Ineffective documentation<\/strong>. A manual system makes it more difficult to update the documentation, including the <strong>revision<\/strong> history, and to recover the data necessary to support the change. For example, a test might be duplicated because the documentation was not updated for the previously performed test.<\/li><li><strong>Training<\/strong>: Adequate staff training is a prerequisite for both FDA and ISO. When training management is not linked to the rest of the quality control processes, especially in manual management, keeping <strong>training up to date<\/strong> with changes in procedures becomes complex. Procedures are usually impacted by Change and having control over the training to be given to staff greatly reduces the <strong>management time<\/strong>.<\/li><\/ul><h2>Change Control Management with a digital system<\/h2><p>Change Request documentation can be managed in printed or electronic form.<\/p><p>Change management using a digital workflow management system not only enables documentation to be protected, organised and available, but also allows <strong>actions to be assigned to those involved<\/strong>, the process to be monitored and notifications to be sent ahead of deadlines, while also keeping backlogs and other critical KPIs under control.<\/p><p>In addition, Change Requests can connect to other processes such as CAPA.<\/p><p>With a digital system, the management of both processes is interdependent, so there is no risk of premature closure of one process over another.<\/p><hr class=\"wp-block-separator has-text-color has-background is-style-wide\" style=\"background-color: #24d900; color: #24d900;\" \/><h2 class=\"wp-block-spacer\" style=\"height: 29px;\" aria-hidden=\"true\">PRAGMA4U<\/h2><div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container\">\u00a0<\/div><\/div><p><a href=\"https:\/\/pragma4u.it\/platform\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">PRAGMA4U<\/a> is a <strong>modular<\/strong> and <strong>scalable<\/strong> Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.<\/p><p>It enables companies to: have <strong>documentation<\/strong> that is protected, always up-to-date, organised and linked to the source processes; assign and implement work<strong>activities<\/strong> directly on the platform; easily share information between departments; keep processes under <strong>control<\/strong> using KPIs; and compile <strong>reports<\/strong> and <strong>dossiers<\/strong> that will be useful for <strong>inspections<\/strong>.<\/p><p>The platform can contain multiple processes, creating a true <strong>digital map of the company<\/strong>. It also integrates with other systems, such as <strong>ERP<\/strong>, simplifying the compilation and updating of data.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-69341390\" data-id=\"69341390\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-5077575c elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"5077575c\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-432b5fb2\" data-id=\"432b5fb2\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:6084,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/computer-system-validation-data-integrity.jpg&quot;}],&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-294cb8af elementor-align-center elementor-widget elementor-widget-button\" data-id=\"294cb8af\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.s4bt.it\/en\/consulting\/computer-system-validation-data-integrity\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CSV &amp; DATA INTEGRITY CONSULTING<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-48b22a45 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"48b22a45\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-b936f0a\" data-id=\"b936f0a\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-548dc162 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"548dc162\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">MORE INFO<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ec128e8 elementor-widget elementor-widget-text-editor\" data-id=\"5ec128e8\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.s4bt.it\/en\/management-of-capa\/\"><em>Discovering CAPA. 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class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-549fd1fc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"549fd1fc\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-42c4b85\" data-id=\"42c4b85\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-5b3d562c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5b3d562c\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-59d5bdcf\" data-id=\"59d5bdcf\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-779b24ae elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"779b24ae\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d10c4fd elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"4d10c4fd\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">SHARE ON SOCIAL MEDIA<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-151f5715 elementor-share-buttons--view-icon elementor-share-buttons--skin-framed elementor-share-buttons--shape-circle elementor-share-buttons--color-custom elementor-grid-0 elementor-widget elementor-widget-share-buttons\" data-id=\"151f5715\" data-element_type=\"widget\" data-widget_type=\"share-buttons.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-grid\" role=\"list\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\" role=\"listitem\">\n\t\t\t\t\t\t<div class=\"elementor-share-btn elementor-share-btn_linkedin\" role=\"button\" tabindex=\"0\" aria-label=\"Share on linkedin\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-linkedin\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\" role=\"listitem\">\n\t\t\t\t\t\t<div class=\"elementor-share-btn elementor-share-btn_facebook\" role=\"button\" tabindex=\"0\" aria-label=\"Share on facebook\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-facebook\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\" role=\"listitem\">\n\t\t\t\t\t\t<div class=\"elementor-share-btn elementor-share-btn_whatsapp\" role=\"button\" tabindex=\"0\" aria-label=\"Share on whatsapp\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-whatsapp\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-grid-item\" role=\"listitem\">\n\t\t\t\t\t\t<div class=\"elementor-share-btn elementor-share-btn_twitter\" role=\"button\" tabindex=\"0\" aria-label=\"Share on twitter\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-share-btn__icon\">\n\t\t\t\t\t\t\t\t<i class=\"fab fa-twitter\" aria-hidden=\"true\"><\/i>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6bb2abc3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6bb2abc3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-44136216\" data-id=\"44136216\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>BLOG Change Control is a key system for ensuring the quality of products and processes, especially in the Life Sciences sector where there are significant regulatory complexities. As defined in the EU GMP Guidelines, Change Control is a formal system whereby qualified representatives from appropriate disciplines review proposed or actual changes that could affect validation. [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10569,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[45,44],"tags":[],"class_list":["post-10567","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digital-transformation-en","category-life-science-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Change Control: sharing, documentation, training and digitalisation<\/title>\n<meta name=\"description\" content=\"Change Control is essential for ensuring the quality of products, especially in the Life Sciences sector where there are many regulatory challenges.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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