{"id":5947,"date":"2024-02-13T13:39:51","date_gmt":"2024-02-13T12:39:51","guid":{"rendered":"https:\/\/staging.thescon.de\/?page_id=5947"},"modified":"2024-02-14T12:00:43","modified_gmt":"2024-02-14T11:00:43","slug":"validation-qualification","status":"publish","type":"page","link":"https:\/\/www.thescon.de\/en\/validation-qualification\/","title":{"rendered":"Validation and Qualification"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5947\" class=\"elementor elementor-5947\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-03be063 e-flex e-con-boxed e-con e-parent\" data-id=\"03be063\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-72d3fb3 e-con-full e-flex e-con e-child\" data-id=\"72d3fb3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2923204 elementor-widget elementor-widget-heading\" data-id=\"2923204\" data-element_type=\"widget\" data-e-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\">Competences<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-240ff24 elementor-widget elementor-widget-heading\" data-id=\"240ff24\" data-element_type=\"widget\" data-e-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\">Validation and Qualification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-593f359 e-con-full e-flex e-con e-child\" data-id=\"593f359\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d929112 e-con-full e-flex e-con e-child\" data-id=\"d929112\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-abceca4 elementor-widget elementor-widget-text-editor\" data-id=\"abceca4\" data-element_type=\"widget\" data-e-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<div id=\"P06ac\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"rz2iC\" class=\"main-text wysiwyg-editor \"><div id=\"P06ac\" class=\"hc_column_cnt col-md-5   \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"rz2iC\" class=\"main-text wysiwyg-editor    \"><p>In the regulated industries, numerous laws, conventions and guidelines (GxP, GDP, cGMP, 21 CFR, ISO 13485, FMD, MDR etc.) require the validation of computerized systems such as ERP systems as well as the underlying <a href=\"https:\/\/www.thescon.de\/en\/infrastructure-qualification\/\">IT infrastructure qualification<\/a>.<\/p><p>Computer system validation (CSV) serves as documented evidence of the functionality of a system for a guarantee of product quality, patient safety and data integrity (GxP compliance).<\/p><p>Change management processes ensure continual maintenance of the valid and qualified system status. It is an essential component of the company\u2019s quality assurance.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f984b8b e-con-full e-flex e-con e-child\" data-id=\"f984b8b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-bf83daf elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"bf83daf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Which of your systems are GxP relevant and therefore need to be validated?<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">What is the scope and sequence of the validation?<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">How can you achieve and maintain a valid system status?<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Which approach fits best to your validation project from a compliance point of view?<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-07eec58 e-flex e-con-boxed e-con e-parent\" data-id=\"07eec58\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-04c58c6 e-con-full e-flex e-con e-child\" data-id=\"04c58c6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-40bee96 elementor-widget elementor-widget-heading\" data-id=\"40bee96\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Our responsibility, our standard<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-85f112d e-con-full e-flex e-con e-child\" data-id=\"85f112d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-94fd627 e-con-full e-flex e-con e-child\" data-id=\"94fd627\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b695d39 elementor-widget elementor-widget-text-editor\" data-id=\"b695d39\" data-element_type=\"widget\" data-e-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<div id=\"P06ac\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"rz2iC\" class=\"main-text wysiwyg-editor \"><div id=\"7E69E\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"6HDuV\" class=\"main-text wysiwyg-editor \"><div id=\"Rk7uR\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"00i98\" class=\"main-text wysiwyg-editor \"><div id=\"Vv4Wj\" class=\"hc_column_cnt col-md-6   \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"3103P\" class=\"main-text wysiwyg-editor    \"><p>Thescon supports you in answering these questions as well as in the management of the resulting project. Based on a risk-based approach, we find an individual and efficacious validation strategy for your company.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d4176bc e-con-full e-flex e-con e-child\" data-id=\"d4176bc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1ee4c8d elementor-widget elementor-widget-text-editor\" data-id=\"1ee4c8d\" data-element_type=\"widget\" data-e-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<div id=\"P06ac\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"rz2iC\" class=\"main-text wysiwyg-editor \"><div id=\"7E69E\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"6HDuV\" class=\"main-text wysiwyg-editor \"><div id=\"Rk7uR\" class=\"hc_column_cnt col-md-5 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"00i98\" class=\"main-text wysiwyg-editor \"><div id=\"GGYqS\" class=\"hc_column_cnt col-md-6   \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"RUPfc\" class=\"main-text wysiwyg-editor    \"><p>Working together with you, we optimize process and data flow models and train your employees to develop a sense for GxP compliance. We support you throughout the validation and qualification process to ensure your long-term success.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2ef070a e-con-full e-flex e-con e-child\" data-id=\"2ef070a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0d586d9 elementor-widget elementor-widget-button\" data-id=\"0d586d9\" data-element_type=\"widget\" data-e-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=\"\/en\/contact\/\">\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\">Contact us<\/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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1adb4d8 e-flex e-con-boxed e-con e-parent\" data-id=\"1adb4d8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8ec2cb3 e-con-full e-flex e-con e-child\" data-id=\"8ec2cb3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-be01e6f elementor-widget elementor-widget-heading\" data-id=\"be01e6f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Competences<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10d62b1 e-con-full e-flex e-con e-child\" data-id=\"10d62b1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-d5f579f e-con-full e-transform e-flex e-con e-child\" data-id=\"d5f579f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_translateX_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-10,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e64baf9 elementor-view-stacked elementor-shape-circle elementor-position-block-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"e64baf9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-bookmark\" viewBox=\"0 0 384 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M336 0H48C21.49 0 0 21.49 0 48v464l192-112 192 112V48c0-26.51-21.49-48-48-48zm0 428.43l-144-84-144 84V54a6 6 0 0 1 6-6h276c3.314 0 6 2.683 6 5.996V428.43z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h4 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tValidation and Qualification\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<p class=\"elementor-icon-box-description\">\n\t\t\t\t\t\tIn the regulated industries firms have to comply with extensive and challenging regulations. Such compliance includes the validation of IT systems as well as the qualification of the underlying infrastructure.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\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-97b913e elementor-widget elementor-widget-button\" data-id=\"97b913e\" data-element_type=\"widget\" data-e-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=\"\/en\/validation-qualification\/\">\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\">Read more<\/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<\/div>\n\t\t<div class=\"elementor-element elementor-element-a69c465 e-con-full e-transform e-flex e-con e-child\" data-id=\"a69c465\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_translateX_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-10,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-90c3817 elementor-view-stacked elementor-shape-circle elementor-position-block-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"90c3817\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-circle\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8zm0 448c-110.5 0-200-89.5-200-200S145.5 56 256 56s200 89.5 200 200-89.5 200-200 200z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h4 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tCompliance and Quality\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<p class=\"elementor-icon-box-description\">\n\t\t\t\t\t\tA good quality management system is in\u00addis\u00adpensable in the regulated industries for com\u00adplying with legal stipulations. Further, con\u00adtinuous system maintenance and im\u00adprove\u00adments to the quality management system con\u00adtributes directly to the success of a firm.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\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-9ab9f70 elementor-widget elementor-widget-button\" data-id=\"9ab9f70\" data-element_type=\"widget\" data-e-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=\"\/en\/compliance-quality\/\">\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\">Read more<\/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<\/div>\n\t\t<div class=\"elementor-element elementor-element-4fe088b e-con-full e-transform e-flex e-con e-child\" data-id=\"4fe088b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_translateX_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-10,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3420670 elementor-view-stacked elementor-shape-circle elementor-position-block-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"3420670\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-clone\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 0H144c-26.51 0-48 21.49-48 48v48H48c-26.51 0-48 21.49-48 48v320c0 26.51 21.49 48 48 48h320c26.51 0 48-21.49 48-48v-48h48c26.51 0 48-21.49 48-48V48c0-26.51-21.49-48-48-48zM362 464H54a6 6 0 0 1-6-6V150a6 6 0 0 1 6-6h42v224c0 26.51 21.49 48 48 48h224v42a6 6 0 0 1-6 6zm96-96H150a6 6 0 0 1-6-6V54a6 6 0 0 1 6-6h308a6 6 0 0 1 6 6v308a6 6 0 0 1-6 6z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h4 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tSoftware selection &amp; Process management\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<p class=\"elementor-icon-box-description\">\n\t\t\t\t\t\tChoosing a new IT software poses a crucial challenge for companies in the regulated industries. Therefore, a well-organized and transparent software selection process is essential in choosing a provider that best suits to the company.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\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-7e2601d elementor-widget elementor-widget-button\" data-id=\"7e2601d\" data-element_type=\"widget\" data-e-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=\"\/en\/software-selection-process-management\/\">\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\">Read more<\/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<\/div>\n\t\t<div class=\"elementor-element elementor-element-42b4e2a e-con-full e-transform e-flex e-con e-child\" data-id=\"42b4e2a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_translateX_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:0,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:-10,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateX_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_translateY_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-27d5cdd elementor-view-stacked elementor-shape-circle elementor-position-block-start elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"27d5cdd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<span  class=\"elementor-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-desktop\" viewBox=\"0 0 576 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M528 0H48C21.5 0 0 21.5 0 48v320c0 26.5 21.5 48 48 48h192l-16 48h-72c-13.3 0-24 10.7-24 24s10.7 24 24 24h272c13.3 0 24-10.7 24-24s-10.7-24-24-24h-72l-16-48h192c26.5 0 48-21.5 48-48V48c0-26.5-21.5-48-48-48zm-16 352H64V64h448v288z\"><\/path><\/svg>\t\t\t\t<\/span>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<h4 class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<span  >\n\t\t\t\t\t\t\tInfrastructure Qualification\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<p class=\"elementor-icon-box-description\">\n\t\t\t\t\t\tRegulated industries must meet important and legal infrastructure qualifications. If the qualification does not follow those guide\u00adlines, unauthorized system access and data manipulation may become real threats to the organization.\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\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-4156caa elementor-widget elementor-widget-button\" data-id=\"4156caa\" data-element_type=\"widget\" data-e-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=\"\/en\/infrastructure-qualification\/\">\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\">Read more<\/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<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Competences Validation and Qualification In the regulated industries, numerous laws, conventions and guidelines (GxP, GDP, cGMP, 21 CFR, ISO 13485, FMD, MDR etc.) require the validation of computerized systems such as ERP systems as well as the underlying IT infrastructure qualification. Computer system validation (CSV) serves as documented evidence of the functionality of a system [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"parent":0,"menu_order":21,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-5947","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/pages\/5947","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/comments?post=5947"}],"version-history":[{"count":11,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/pages\/5947\/revisions"}],"predecessor-version":[{"id":5958,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/pages\/5947\/revisions\/5958"}],"wp:attachment":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/media?parent=5947"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}