{"id":10535,"date":"2021-10-04T09:09:14","date_gmt":"2021-10-04T07:09:14","guid":{"rendered":"https:\/\/www.s4bt.it\/electronic-dossier-inspections\/"},"modified":"2021-12-03T12:03:50","modified_gmt":"2021-12-03T11:03:50","slug":"electronic-dossier-inspections","status":"publish","type":"post","link":"https:\/\/www.s4bt.it\/en\/electronic-dossier-inspections\/","title":{"rendered":"Handling inspections (well) through an electronic dossier"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10535\" class=\"elementor elementor-10535 elementor-1313\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f6974a3 elementor-section-height-min-height elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"f6974a3\" 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-7f62f705\" data-id=\"7f62f705\" 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-7d07778 elementor-widget elementor-widget-heading\" data-id=\"7d07778\" 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-2b67ddc7 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2b67ddc7\" 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-4b2197e elementor-hidden-desktop elementor-hidden-tablet elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"4b2197e\" 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\">Handling inspections (well) through an electronic dossier<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c67f1a5 elementor-hidden-phone elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"4c67f1a5\" 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\">Handling inspections (well) through an electronic dossier<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ef1c61 elementor-widget elementor-widget-post-info\" data-id=\"5ef1c61\" 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-3b2d6023 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3b2d6023\" 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-42397e68\" data-id=\"42397e68\" 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-7b3aa7cc elementor-widget elementor-widget-text-editor\" data-id=\"7b3aa7cc\" 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>Life Science companies are subject to frequent inspections by\u00a0<strong>partners<\/strong>,\u00a0<strong>agencies<\/strong> and <strong>authorities<\/strong>. For example, you may receive an inspection when you introduce new lines, produce for new markets or simply have routine and\/or follow-up inspections to check that the company is in line with regulations and guidelines.<\/p><p>A crucial stage during an inspection is the\u00a0<strong>examination and review of documentation<\/strong>\u00a0by the auditors, both in the preparation phase and during and after the inspection.<\/p><p>The\u00a0<strong>documentation<\/strong>\u00a0needed can be of any kind:<\/p><ul><li>Personnel qualifications and training<\/li><li>Standard Operating Procedures (SOPs)<\/li><li>Qualification reports<\/li><li>Validation reports<\/li><li>Complaints<\/li><li>Change Control<\/li><li>Deviations<\/li><li>Etc.<\/li><\/ul><h2>Documentation Review &#8211; Remote Audits and Inspections<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>Documentation review has become an even more important activity for\u00a0<strong>remote Audits<\/strong>, which, due to safety and travel constraints, have been replacing in-person audits over the last year, thanks to the great\u00a0<strong>technological flexibility<\/strong>\u00a0we have.<\/p><p>In remote Audits, the company\u00a0<strong>being inspected<\/strong>\u00a0(auditee) sends the required documentation to the inspectors (auditors) via a shared and previously agreed platform.<\/p><p>Now, imagine this documentation stage using\u00a0<strong>paper systems<\/strong>, from the initial search for the document, to scanning it, saving the file in the folder and then sending. Quite a\u00a0<strong>cumbersome<\/strong> process, if we consider, too, that it must be repeated for many documents.<\/p><p>Having those documents in digital form, on spreadsheets or in text files and saved in network folders, would certainly reduce the time involved. We also know that even in the most precise organisation, paper files in folders are prone to\u00a0<strong>errors<\/strong>,\u00a0<strong>losses<\/strong> and\u00a0<strong>deterioration<\/strong>.\u00a0<\/p><p>\u00a0<\/p><h2>Electronic dossier<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p><strong>Digitalising<\/strong>\u00a0\u00a0<strong>work processes<\/strong>\u00a0on a software platform that complies with regulatory standards and offers the ability to manage assets, digital signatures, attachments and documents is crucial during an inspection.\u00a0<\/p><p>Here is a\u00a0<strong>practical example<\/strong>. An inspector wants to see documentation on deviations and related CAPAs for a particular batch. For\u00a0<strong>paper documentation<\/strong>, as mentioned above, we would need to search in the archive folders, then scan them and share on the platform. For\u00a0<strong>network files and folders,<\/strong>\u00a0if we are organised, then we can &#8220;manage&#8221; with searching for all batch-related files and sharing them.<\/p><p>With a\u00a0<strong>digital platform<\/strong>, by entering the batch number and using a simple search, we can trace one or more of the deviations the batch has encountered, the documents signed electronically, the tasks performed and also the relevant CAPAs. Once we have entered the single deviations process, we can\u00a0<strong>extract a dossier<\/strong>, i.e. a protected pdf document summarising all information on the deviation and related processes and tasks, updated in real time and including attachments.\u00a0<\/p><p>The dossier can be opened,\u00a0<strong>viewed<\/strong>,\u00a0<strong>saved<\/strong>\u00a0and\u00a0<strong>printed<\/strong>, if necessary.\u00a0During an inspection, especially remotely, it is extremely\u00a0<strong>easy<\/strong>\u00a0to go back to the documentation and share the dossier as a generated pdf file.<\/p><h2>Customised Electronic Dossiers<\/h2><div class=\"wp-block-spacer\" style=\"height: 50px;\" aria-hidden=\"true\">\u00a0<\/div><p>The\u00a0<strong>Standard<\/strong>\u00a0Electronic Dossiers contain all the information on the process (tasks, owners, attachments and documents, etc.).\u00a0<\/p><p>However, not all companies can, or will, share such information with third parties, if not necessarily required to do so.<\/p><p>With <a href=\"https:\/\/pragma4u.it\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">PRAGMA4U<\/a> , companies can create <strong>customised dossiers<\/strong>, entering the <strong>relevant process information<\/strong> that they want to pass on to the other party. This makes it possible to use the document for sending information to third parties, such as inspectors, but also, for example, as documentation for a customer in the event of a complaint.<\/p><div class=\"wp-block-spacer\" style=\"height: 60px;\" aria-hidden=\"true\">\u00a0<\/div><hr id=\"scopri-pragma\" class=\"wp-block-separator has-text-color has-background is-style-wide\" style=\"background-color: #24d900; color: #24d900;\" \/><h2>PRAGMA4U<\/h2><div class=\"wp-block-spacer\" style=\"height: 49px;\" aria-hidden=\"true\">\u00a0<\/div><p><a href=\"https:\/\/pragma4u.it\/platform\/?lang=en\" target=\"_blank\" rel=\"noreferrer noopener\">PRAGMA4U<\/a>\u00a0is a\u00a0<strong>modular<\/strong>\u00a0and\u00a0<strong>scalable<\/strong>\u00a0Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.<\/p><p>It enables companies to: have\u00a0<strong>documentation<\/strong>\u00a0that is protected, always up-to-date, organised and linked to the source processes; assign and implement\u00a0work<strong>activities<\/strong>\u00a0directly on the platform; easily share information between departments; keep\u00a0processes under <strong>control<\/strong>\u00a0using KPIs; and compile\u00a0<strong>reports<\/strong>\u00a0 and\u00a0<strong>dossiers<\/strong>\u00a0 that will be useful\u00a0for <strong>inspections<\/strong>.<\/p><p>The platform can contain multiple processes, creating a true\u00a0<strong>digital map of the company<\/strong>. It also integrates with other systems, such as\u00a0<strong>ERP,<\/strong>\u00a0simplifying 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-151e8189\" data-id=\"151e8189\" 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-49cdda7f elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"49cdda7f\" 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-2cf5cfe7\" data-id=\"2cf5cfe7\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:6961,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/digital-business-and-technology-SNQVNDV.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-7252a02a elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7252a02a\" 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:\/\/pragma4u.it\/?lang=en\" target=\"_blank\">\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\">PRAGMA4U<\/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-5b35d373 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5b35d373\" 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-18f4688a\" data-id=\"18f4688a\" 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-5880ca80 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"5880ca80\" 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-73d43e5e elementor-widget elementor-widget-text-editor\" data-id=\"73d43e5e\" 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. Tools and techniques for optimising the process<\/em><\/a><\/p>\n<p><em><a href=\"https:\/\/www.s4bt.it\/change-control-digitalizzazione\/\">The challenges of Change Control: sharing, documentation, training and digitisation<\/a><\/em><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-758cdeb elementor-widget elementor-widget-heading\" data-id=\"758cdeb\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Subscribe to our newsletter<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-61e59adf elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"61e59adf\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div 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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-29ee8e0 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=\"29ee8e0\" 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\" 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For example, you may receive an inspection when you introduce new lines, produce for new markets or simply have routine and\/or follow-up inspections to check that the company is in line with regulations and guidelines. A crucial stage during an inspection is the\u00a0examination [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10542,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[45,44],"tags":[],"class_list":["post-10535","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>Handling inspections (well) through an electronic dossier - Blog - S4BT.it<\/title>\n<meta name=\"description\" content=\"Documentation review is crucial during inspections and the electronic dossier allows you to provide complete information quickly.\" \/>\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.s4bt.it\/en\/electronic-dossier-inspections\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Handling inspections (well) through an electronic dossier - 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