{"id":12544,"date":"2026-03-23T12:39:57","date_gmt":"2026-03-23T11:39:57","guid":{"rendered":"https:\/\/dhc.ima.vc\/gxp-friendly-audit-fuer-saas-plattform\/"},"modified":"2026-05-09T23:51:45","modified_gmt":"2026-05-09T21:51:45","slug":"gxp-friendly-audit-for-saas-platform","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/","title":{"rendered":"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12544\" class=\"elementor elementor-12544 elementor-5860\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f897850 e-con-full e-flex e-con e-parent\" data-id=\"f897850\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ae80faa e-flex e-con-boxed e-con e-child\" data-id=\"ae80faa\" 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-21d8f3a e-con-full e-flex e-con e-child\" data-id=\"21d8f3a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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<div class=\"elementor-element elementor-element-2f1a1d65 e-flex e-con-boxed e-con e-parent\" data-id=\"2f1a1d65\" 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-8b07514 e-con-full e-flex e-con e-child\" data-id=\"8b07514\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5e177196 e-con-full e-flex e-con e-child\" data-id=\"5e177196\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2749cd7f elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2749cd7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7755013d elementor-widget elementor-widget-text-editor\" data-id=\"7755013d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-testid=\"markdown-response\"><p id=\"message\">As part of an independent <strong>GxP Friendly Audit<\/strong>, the <strong>SaaS platform Ledidi Trials<\/strong> was comprehensively evaluated by DHC. The objective was the structured, transparent, and risk-based assessment of its regulatory suitability for use in GxP-regulated clinical trials.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17a14cbf elementor-author-box--align-left elementor-author-box--layout-image-left elementor-widget elementor-widget-author-box\" data-id=\"17a14cbf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/Thomas-Pauly-300x300.webp\" alt=\"Picture of Thomas Pauly, Practice Manager, DHC GmbH\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\t\t\t\t\t<div >\n\t\t\t\t\t\t<div class=\"elementor-author-box__name\">\n\t\t\t\t\t\t\tThomas Pauly, Practice Manager, DHC GmbH\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\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-6194c5a2 e-con-full e-flex e-con e-child\" data-id=\"6194c5a2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-571a5a01 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"571a5a01\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"350\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp\" class=\"attachment-full size-full wp-image-13526\" alt=\"Two people in lab attire looking at a tablet \u2014 symbolizing the evaluation of a GxP-compliant SaaS platform for clinical trials.\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp 1200w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit-300x88.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit-1024x299.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit-768x224.webp 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-49e17216 e-flex e-con-boxed e-con e-parent\" data-id=\"49e17216\" 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-7989692a e-con-full e-flex e-con e-child\" data-id=\"7989692a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4ab08e4a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4ab08e4a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">The article shows how audit results can be used as supplier evidence for <strong>risk-based supplier qualification<\/strong>, and that the audit does not replace internal <a href=\"https:\/\/dhc.ima.vc\/gxp-compliance\/softwarevalidierung\/\"><strong>validation (CSV\/CSA)<\/strong><\/a>, but typically significantly accelerates and streamlines it.<\/p><p style=\"text-align: left;\">The regulatory assessment of SaaS platforms intended for use in GxP-relevant processes is of high importance. Cloud-based solutions in particular place the focus on topics such as data integrity, electronic signatures, IT security, and supplier qualification.<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f944eeb e-flex e-con-boxed e-con e-parent\" data-id=\"f944eeb\" 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-2871744 e-con-full e-flex e-con e-child\" data-id=\"2871744\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49ea18a elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"49ea18a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is a GxP-Friendly Audit?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41fe603 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"41fe603\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">A GxP Friendly Audit is an <strong>independent, preparatory audit without formal inspection function<\/strong>.<\/p><p style=\"text-align: left;\"><strong>It serves to:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Assess the regulatory maturity of a system or SaaS provider<\/li><li>Identify possible compliance risks and, optionally, provide recommendations for action<\/li><li>Support risk-based supplier qualification<\/li><li>Prepare for customer audits or regulatory inspections<\/li><\/ul><p style=\"text-align: left;\">Unlike traditional supplier audits, the focus here is on the supportive, structured analysis of GxP readiness.<\/p><p style=\"text-align: left;\">Especially for SaaS providers in regulated environments, a Friendly Audit is a strategic instrument for GxP compliance.<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4abd488 e-flex e-con-boxed e-con e-parent\" data-id=\"4abd488\" 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-b97ffdf e-con-full e-flex e-con e-child\" data-id=\"b97ffdf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-26e241f elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"26e241f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">About Ledidi Trials<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-655cda3 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"655cda3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\"><a href=\"https:\/\/ledidi.com\/platform\/features\/platform-features-trials-module\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><img decoding=\"async\" class=\"alignright wp-image-11372 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/ledidi.webp\" alt=\"Logo of Ledidi, provider of clinical data and research software\" width=\"300\" height=\"157\" \/><\/a>Ledidi is a technology company focused on digital solutions for data-driven clinical research. The goal is to enable sponsors, CROs, and study teams to plan, conduct, and evaluate studies more efficiently through modern software approaches.<\/p><p style=\"text-align: left;\">With Ledidi Trials, the company offers a <strong>SaaS-based platform supporting clinical study processes<\/strong>. Key focus areas include:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Structured data processing<\/li><li>Collaborative work processes<\/li><li>Transparency between study participants<\/li><li>Digital support of regulatory requirements<\/li><\/ul><p style=\"text-align: left;\">The solution is designed for use in regulated clinical research environments and is continuously developed to meet current regulatory and industry requirements.<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3b052d1 e-flex e-con-boxed e-con e-parent\" data-id=\"3b052d1\" 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-86dc434 e-con-full e-flex e-con e-child\" data-id=\"86dc434\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-07124c9 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"07124c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Audit Approach and Regulatory Framework\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fcd44c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"1fcd44c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">The audit was conducted as an independent, risk-based GxP Friendly Audit aligned with international regulatory requirements and guidelines, including:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures)<\/li><li>ICH GCP E6(R3)<\/li><li>ISPE GAMP 5 (risk-based approach for computerized systems)<\/li><\/ul><p style=\"text-align: left;\">The focus was on a supplier-side assessment of:<\/p><ul class=\"check-list\"><li style=\"text-align: left;\">Adequacy of the quality management system<\/li><li style=\"text-align: left;\">Effectiveness of development and control mechanisms<\/li><li style=\"text-align: left;\">Suitability of operational processes<\/li><li style=\"text-align: left;\">Suitability for use in GxP-regulated clinical trials<\/li><\/ul>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a186792 e-flex e-con-boxed e-con e-parent\" data-id=\"a186792\" 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-2a6a54a e-con-full e-flex e-con e-child\" data-id=\"2a6a54a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-64385fb elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"64385fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Scope of the GxP Audit for the SaaS Platform\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9de4a88 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"9de4a88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">The audit covered the following central areas:<\/p><p style=\"text-align: left;\"><strong>Quality Management System (QMS)<\/strong><\/p><ul style=\"text-align: left;\"><li>Structure and documentation<\/li><li>Roles and responsibility models<\/li><li>CAPA and change management<\/li><\/ul><p style=\"text-align: left;\"><strong>Software Development Lifecycle (SDLC)<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Development processes<\/li><li>Agile methods and documentation<\/li><li>Traceability and accountability<\/li><\/ul><p style=\"text-align: left;\"><strong>Release and Change Management<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Formalized release processes<\/li><li>Controlled version management<\/li><li>Impact and risk analyses<\/li><\/ul><p style=\"text-align: left;\"><strong>SaaS Operations and IT Security<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Access controls<\/li><li>Role-based authorization<\/li><li>Electronic signatures<\/li><li>Data security measures<\/li><\/ul><p style=\"text-align: left;\"><strong>Data Integrity and Business Continuity<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Backup strategies<\/li><li>Disaster recovery<\/li><li>Business continuity management<\/li><li>Audit trails<\/li><li>Ensuring ALCOA+ principles<\/li><\/ul>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d5792e e-flex e-con-boxed e-con e-parent\" data-id=\"4d5792e\" 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-84118aa e-con-full e-flex e-con e-child\" data-id=\"84118aa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3882fbe elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3882fbe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Audit Results<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-80391f8 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"80391f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">The independent Friendly Audit confirmed that Ledidi Trials has implemented a <strong>comprehensive and structured quality system<\/strong>.<\/p><p style=\"text-align: left;\">The final audit report contains <strong>no open deviations<\/strong> and confirms the platform&#8217;s fundamental readiness for use in GxP-regulated clinical trials.<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e86d2a2 e-flex e-con-boxed e-con e-parent\" data-id=\"e86d2a2\" 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-ffbb15e e-con-full e-flex e-con e-child\" data-id=\"ffbb15e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85b56d1 elementor-widget__width-initial elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"85b56d1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-quote-left\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 256h-80v-64c0-35.3 28.7-64 64-64h8c13.3 0 24-10.7 24-24V56c0-13.3-10.7-24-24-24h-8c-88.4 0-160 71.6-160 160v240c0 26.5 21.5 48 48 48h128c26.5 0 48-21.5 48-48V304c0-26.5-21.5-48-48-48zm-288 0H96v-64c0-35.3 28.7-64 64-64h8c13.3 0 24-10.7 24-24V56c0-13.3-10.7-24-24-24h-8C71.6 32 0 103.6 0 192v240c0 26.5 21.5 48 48 48h128c26.5 0 48-21.5 48-48V304c0-26.5-21.5-48-48-48z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4611133 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4611133\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>&#8220;The Friendly Audit conducted by DHC and the resulting report provided us with inspection-ready evidence on electronic records and signatures, audit trails, and traceability, aligned with recognized regulatory expectations. This made sponsor discussions and vendor qualification reviews significantly easier and more efficient.&#8221;<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b1f80a elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"9b1f80a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Danckert Mellbye<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aee0894 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"aee0894\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Chief Operating Officer, Ledidi AS\n<\/div>\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-de129ac e-flex e-con-boxed e-con e-parent\" data-id=\"de129ac\" 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-9f45285 e-con-full e-flex e-con e-child\" data-id=\"9f45285\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-57c00d5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"57c00d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Use of the Audit Results for Supplier Qualification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6b7c04 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d6b7c04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">The audit results can be used by sponsors and CROs as part of risk-based supplier qualification according to ISPE GAMP 5.<\/p><p style=\"text-align: left;\"><strong>Important:<\/strong><\/p><p style=\"text-align: left;\">The responsibility for system validation and intended use remains with the regulated organization at all times.<\/p><p style=\"text-align: left;\">However, a GxP Friendly Audit significantly supports:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Reduction of qualification effort<\/li><li>Increased transparency for sponsors<\/li><li>Acceleration of contract and selection processes<\/li><li>Strengthening of the compliance position<\/li><\/ul>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5476352 e-flex e-con-boxed e-con e-parent\" data-id=\"5476352\" 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-33f016f e-con-full e-flex e-con e-child\" data-id=\"33f016f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9826057 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"9826057\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why are GxP-Friendly Audits strategically important for SaaS Providers?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c2a810c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"c2a810c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Cloud and SaaS solutions in the life sciences environment are subject to specific regulatory requirements.<\/p><p style=\"text-align: left;\"><strong>Challenges include:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Division of responsibilities between provider and regulated organization<\/li><li>Validation of cloud-based systems<\/li><li>Ensuring data integrity<\/li><li>Auditability of agile development processes<\/li><li>Regulatory expectations for electronic systems<\/li><\/ul><p style=\"text-align: left;\"><strong>An independent GxP audit provides:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Regulatory transparency<\/li><li>Customer trust<\/li><li>Structured compliance evidence<\/li><li>Competitive advantages in the regulated market<\/li><\/ul>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e4a4c11 e-flex e-con-boxed e-con e-parent\" data-id=\"e4a4c11\" 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-17e9917 e-con-full e-flex e-con e-child\" data-id=\"17e9917\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad8f3ee elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"ad8f3ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">GxP-Friendly Audits for SaaS Providers in regulated Industries<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2aca94e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"2aca94e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Are you planning to deploy a SaaS solution in GxP-regulated processes? Or would you like to have your regulatory maturity structurally assessed as a software provider?<\/p><p style=\"text-align: left;\"><strong>DHC Dr. Herterich &amp; Consultants supports you with:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>GxP Friendly Audits<\/li><li>Supplier qualification<\/li><li>CSV and CSA strategies<\/li><li>Regulatory assessments of cloud-based systems<\/li><li>Compliance optimization for digital platforms<\/li><\/ul><div style=\"text-align: left;\">More about DHC consulting services for <a href=\"https:\/\/dhc.ima.vc\/en\/gxp-compliance\/audit-readiness\/\"><strong>Audit Readiness <\/strong><span style=\"text-align: center; font-size: 17.3884px;\"><b>\u2192<\/b><\/span><\/a><\/div>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1aac793a e-flex e-con-boxed e-con e-child\" data-id=\"1aac793a\" 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-41223ab3 e-con-full e-flex e-con e-child\" data-id=\"41223ab3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1117cb89 e-con-full e-flex e-con e-child\" data-id=\"1117cb89\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7571e62 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"7571e62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">GxP-Friendly Audits for SaaS providers in regulated industries<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fc7341d elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1fc7341d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tAre you preparing for a Supplier or SaaS Audit?\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b9cfc72 elementor-mobile-align-center custom-button elementor-widget elementor-widget-button\" data-id=\"4b9cfc72\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dhc.ima.vc\/en\/book-meeting\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Book a free Initial Consultation<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-293cbc43 e-con-full e-flex e-con e-child\" data-id=\"293cbc43\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68de9688 elementor-author-box--image-valign-middle elementor-widget elementor-widget-author-box\" data-id=\"68de9688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/karsten-schulz-dhc-experte-300x300.webp\" alt=\"Author picture\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28880ae3 e-flex e-con-boxed e-con e-parent\" data-id=\"28880ae3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a20d850 elementor-widget elementor-widget-heading\" data-id=\"2a20d850\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">FAQs<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18ce6bf5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"18ce6bf5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently asked Questions about GxP-Friendly Audits for SaaS Providers (FAQ)\n<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-44e5fd59 e-con-full e-flex e-con e-child\" data-id=\"44e5fd59\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7aa4d553 elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"7aa4d553\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2050\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2050\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is a \u201cGxP-Friendly Audit\u201d for SaaS Platforms \u2013 and how does it differ from a traditional Supplier or IT Audit? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2050\" class=\"elementor-element elementor-element-36557191 e-con-full e-flex e-con e-child\" data-id=\"36557191\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2050\" class=\"elementor-element elementor-element-463d48e e-flex e-con-boxed e-con e-child\" data-id=\"463d48e\" 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\t\t<div class=\"elementor-element elementor-element-46a5d711 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"46a5d711\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>A GxP Friendly Audit is a risk-based, SaaS-ready supplier\/platform audit that specifically examines the controls critical for GxP compliance and auditability (e.g., data integrity, access controls, change\/release, incident\/DR). It takes into account the cloud reality (multi-tenant, standard product, frequent releases, limited individual audit access).<\/p><p><strong>Differences from a traditional audit:<\/strong><\/p><ul><li><strong>Shared Responsibility<\/strong> in focus: Clear delineation of what the SaaS provider is responsible for and what the customer must ensure organizationally\/procedurally.<\/li><li><strong>Evidence pragmatic<\/strong>: Uses realistic SaaS evidence (e.g., SOC\/ISO, trust center artifacts) rather than expecting &#8220;on-prem&#8221; artifacts that SaaS often cannot provide.<\/li><li><strong>GxP impact<\/strong> instead of full coverage: Preferably examines GxP-critical areas rather than &#8220;everything theoretically possible.&#8221;<\/li><li><strong>Decision-oriented:<\/strong> Delivers a go\/no-go-ready assessment including conditions and action plan.<\/li><\/ul>\t\t\t\t\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\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2051\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2051\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which Regulations and Guidelines does a GxP-Friendly SaaS Audit typically address? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2051\" class=\"elementor-element elementor-element-30dabbe8 e-con-full e-flex e-con e-child\" data-id=\"30dabbe8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2051\" class=\"elementor-element elementor-element-419e22f6 e-flex e-con-boxed e-con e-child\" data-id=\"419e22f6\" 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\t\t<div class=\"elementor-element elementor-element-5568af38 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"5568af38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>A GxP Friendly Audit typically &#8220;maps&#8221; SaaS controls to the regulatory expectations around computerized systems and data integrity. Common references include:<\/p><ul><li><strong>EU GMP including Annex 11<\/strong>: Expectations regarding operations, security, data integrity, audit trails, supplier management, changes.<\/li><li><strong>GAMP 5<\/strong>: Guideline for risk-based approach, supplier assessment, appropriate verification\/validation.<\/li><li><strong>FDA 21 CFR Part 11<\/strong> (if applicable): Requirements for electronic records and electronic signatures.<\/li><li><strong>Data Integrity (ALCOA+)<\/strong> as guiding principle: Traceability, completeness, immutability, availability.<\/li><\/ul><p>Important for decision-makers:<br \/>Not every SaaS usage is automatically &#8220;Part 11-critical.&#8221; Relevance strongly depends on whether the platform creates\/manages GxP records and whether electronic signatures are used.<\/p>\t\t\t\t\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\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2052\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2052\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which Audit Areas are most important in a GxP-Friendly Audit for SaaS? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2052\" class=\"elementor-element elementor-element-2b933db4 e-con-full e-flex e-con e-child\" data-id=\"2b933db4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2052\" class=\"elementor-element elementor-element-77fefc68 e-flex e-con-boxed e-con e-child\" data-id=\"77fefc68\" 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\t\t<div class=\"elementor-element elementor-element-8239be5 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"8239be5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The most important audit focus areas are the controls that directly affect data integrity, compliance traceability, and operational security:<\/p><p><strong>Audit Trail &amp; Data Integrity<\/strong><\/p><ul><li>Is the audit trail complete (who\/what\/when\/why), activatable\/configurable, protectable, and evaluable?<\/li><li>Can records\/audit trails be exported and used long-term for audits?<\/li><\/ul><p><strong>Identity &amp; Access Management (IAM)<\/strong><\/p><ul class=\"check-list\"><li>Role\/authorization concept (RBAC), least privilege, admin controls<\/li><li>MFA\/SSO, user lifecycle (joiner\/mover\/leaver), recertifications<\/li><\/ul><p><strong>Change &amp; Release Management (SaaS Updateability)<\/strong><\/p><ul><li>How are changes tested, approved, and communicated?<\/li><li>Are there impact assessments, release notes, possibly feature toggles\/configurable functions?<\/li><\/ul><p><strong>Backup\/Restore &amp; Business Continuity \/ Disaster Recovery<\/strong><\/p><ul><li>Defined RPO\/RTO, restore tests, evidence of DR exercises<\/li><li>Availability &amp; recoverability of GxP-critical data<\/li><\/ul><p><strong>Incident, Problem &amp; Vulnerability Management<\/strong><\/p><ul><li>Reporting processes, SLAs, RCA, CAPA mechanisms<\/li><li>Patch\/vulnerability handling, security monitoring<\/li><\/ul><p>Additionally often decisive: Data location\/subprocessor transparency, logging\/monitoring, interfaces &amp; integrations, configuration control.<\/p>\t\t\t\t\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\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2053\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2053\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which Evidence and Documentation are accepted in a GxP-Friendly Audit for SaaS? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2053\" class=\"elementor-element elementor-element-6047a741 e-con-full e-flex e-con e-child\" data-id=\"6047a741\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2053\" class=\"elementor-element elementor-element-5b87de1e e-flex e-con-boxed e-con e-child\" data-id=\"5b87de1e\" 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\t\t<div class=\"elementor-element elementor-element-4f29af84 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4f29af84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Accepted evidence typically includes standardized, audited proof and process artifacts that demonstrate the effectiveness of controls, e.g.:<\/p><ul><li><strong>SOC 2 Type II<\/strong> (including scope\/period and tested controls)<\/li><li><strong>ISO 27001 certification<\/strong> (plus relevant annexes\/scope, possibly Statement of Applicability)<\/li><li><strong>Trust Center \/ Compliance Portal<\/strong> (policies, process descriptions, control overviews)<\/li><li><strong>SDLC\/change process evidence<\/strong> (release notes, change workflows, test summaries)<\/li><li><strong>BCP\/DR evidence<\/strong> (DR test reports, results, improvement measures)<\/li><li><strong>Incident\/security evidence<\/strong> (process, ticket\/RCA examples in anonymized form)<\/li><li><strong>Subprocessor lists &amp; Data Processing Agreements (DPA)<\/strong>, data flow\/architecture overviews<\/li><\/ul>\t\t\t\t\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\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2054\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2054\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Can a GxP-Friendly Audit replace Validation (CSV\/CSA)? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2054\" class=\"elementor-element elementor-element-4c981568 e-con-full e-flex e-con e-child\" data-id=\"4c981568\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2054\" class=\"elementor-element elementor-element-1e630a21 e-flex e-con-boxed e-con e-child\" data-id=\"1e630a21\" 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\t\t<div class=\"elementor-element elementor-element-5153330f elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"5153330f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>A GxP Friendly Audit typically does not fully replace an internal customer validation, but it can significantly streamline and accelerate it.<\/p><p>What the audit typically delivers:<\/p><ul><li>Verifies the <strong>provider controls<\/strong> (e.g., security, ops, SDLC) as a reliable basis for supplier qualification<\/li><li>Provides input for <strong>CSA\/CSV scope<\/strong>: What can be adopted as &#8220;supplier evidence,&#8221; and what must the customer test themselves?<\/li><li>Creates a <strong>shared responsibility matrix<\/strong> that derives clear customer actions (SOPs, role model, periodic review, configuration control)<\/li><\/ul>\t\t\t\t\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\t\t\t<\/details>\n\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-643854bd e-flex e-con-boxed e-con e-parent\" data-id=\"643854bd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fd289b3 elementor-widget elementor-widget-heading\" data-id=\"4fd289b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Magazine<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52106f4c elementor-widget elementor-widget-heading\" data-id=\"52106f4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">More Articles from the Blog<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25940306 elementor-grid-tablet-1 elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"25940306\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:2842,&quot;columns_tablet&quot;:1,&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-loop-container elementor-grid\">\n\t\t<style id=\"loop-2842\">.elementor-2842 .elementor-element.elementor-element-adf3d07{--display:flex;--justify-content:space-between;--gap:20px 20px;--row-gap:20px;--column-gap:20px;border-style:solid;--border-style:solid;border-width:1px 1px 1px 1px;--border-top-width:1px;--border-right-width:1px;--border-bottom-width:1px;--border-left-width:1px;border-color:#44444444;--border-color:#44444444;--border-radius:20px 20px 20px 20px;--margin-top:0px;--margin-bottom:0px;--margin-left:0px;--margin-right:0px;--padding-top:20px;--padding-bottom:30px;--padding-left:20px;--padding-right:20px;--e-con-transform-origin-x:center;--e-con-transform-origin-y:center;}.elementor-2842 .elementor-element.elementor-element-adf3d07:hover{border-style:solid;border-width:1px 1px 1px 1px;--border-top-width:1px;--border-right-width:1px;--border-bottom-width:1px;--border-left-width:1px;border-color:var( --e-global-color-accent );--border-color:var( --e-global-color-accent );}.elementor-2842 .elementor-element.elementor-element-adf3d07, .elementor-2842 .elementor-element.elementor-element-adf3d07::before{--border-transition:0.3s;}.elementor-2842 .elementor-element.elementor-element-adf3d07.e-con:hover{--e-con-transform-scale:1.03;}.elementor-widget-theme-post-title .elementor-heading-title{font-family:var( --e-global-typography-primary-font-family ), Sans-serif;font-size:var( --e-global-typography-primary-font-size );font-weight:var( --e-global-typography-primary-font-weight );color:var( --e-global-color-primary );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-family:var( --e-global-typography-0dec4fd-font-family ), Sans-serif;font-size:var( --e-global-typography-0dec4fd-font-size );font-weight:var( --e-global-typography-0dec4fd-font-weight );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}.elementor-widget-theme-post-excerpt{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );color:var( --e-global-color-text );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}.elementor-widget-icon.elementor-view-stacked .elementor-icon{background-color:var( --e-global-color-primary );}.elementor-widget-icon.elementor-view-framed .elementor-icon, .elementor-widget-icon.elementor-view-default .elementor-icon{color:var( --e-global-color-primary );border-color:var( --e-global-color-primary );}.elementor-widget-icon.elementor-view-framed .elementor-icon, .elementor-widget-icon.elementor-view-default .elementor-icon svg{fill:var( --e-global-color-primary );}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon-wrapper{text-align:center;}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon{font-size:54px;}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon svg{height:54px;}.elementor-2842 .elementor-element.elementor-element-2511066{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}@media(max-width:1024px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--justify-content:space-evenly;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}@media(min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:1024px) and (min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:767px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--min-height:0px;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}\/* Start custom CSS for container, class: .elementor-element-adf3d07 *\/.elementor-2842 .elementor-element.elementor-element-adf3d07{\n    position: relative;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .icon-more-posts{\n    position: absolute;\n    bottom: 20px;\n    left: 0;\n    right: 0;\n    opacity: 0;\n    transform: translateY(8px);\n    transition: opacity 0.3s ease, transform 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .icon-more-posts{\n    opacity: 1;\n    transform: translateY(0);\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .loop-post-excerpt{\n    padding-bottom: 0;\n    transition: padding-bottom 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .loop-post-excerpt{\n    padding-bottom: 70px;\n}\/* End custom CSS *\/<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-16130 post-16130 post type-post status-publish format-standard has-post-thumbnail hentry category-gxp-compliance-csv tag-cloud-validierung tag-public-cloud-validierung\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/en\/sap-innovation-meets-gxp-compliance\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SAP Innovation Meets GxP Compliance<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tHow Are Cloud, SaaS, AI &amp; Frequent Releases Changing Validation?\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-12542 post-12542 post type-post status-publish format-standard has-post-thumbnail hentry category-sap-qualitaetsmanagement tag-qm-mit-sap tag-qm-with-sap tag-sap-qim tag-sap-qm\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/en\/sap-qim-end-of-support-and-replacement\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SAP QIM End of Support 2027: Why Companies should act now<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tSAP QIM support ends in 2027: Learn what risks arise and why an early migration to QM in S\/4HANA is\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-12544 post-12544 post type-post status-publish format-standard has-post-thumbnail hentry category-gxp-compliance-csv\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tAs part of an independent GxP Friendly Audit, the SaaS platform Ledidi Trials was comprehensively evaluated by DHC.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\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>As part of an independent GxP Friendly Audit, the SaaS platform Ledidi Trials was comprehensively evaluated by DHC.<\/p>\n","protected":false},"author":2,"featured_media":13526,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[98,99],"tags":[],"class_list":["post-12544","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gxp-compliance-csv"],"acf":[],"yoast_title":"%%title%% %%page%%","yoast_metadesc":"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.","elementor_data":[{"id":"f897850","elType":"container","settings":{"flex_direction":"column","flex_gap":{"column":"0","row":"0","isLinked":true,"unit":"px","size":0},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"width_tablet":{"unit":"%","size":"","sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"boxed_width":{"unit":"px","size":1336,"sizes":[]},"flex_align_items":"center","_flex_align_self":"center","_flex_size":"grow"},"elements":[{"id":"ae80faa","elType":"container","settings":{"flex_direction":"column","background_background":"classic","background_image":{"url":"","id":"","size":"","alt":"","source":"library"},"margin":{"unit":"px","top":"0","right":"0","bottom":"30","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"width":{"unit":"%","size":98,"sizes":[]},"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"_title":"Keyvisual","margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"background_image_mobile":{"url":"","id":"","size":"","alt":"","source":"library"},"background_position_mobile":"bottom left","background_size_mobile":"cover","boxed_width":{"unit":"px","size":1336,"sizes":[]},"flex_align_items":"center"},"elements":[{"id":"21d8f3a","elType":"container","settings":{"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","background_image":{"id":14450,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/unterseite_keyvisual.webp","alt":"","source":"library","size":""},"background_position":"bottom center","background_repeat":"no-repeat","background_size":"cover","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_title":"Background","boxed_width":{"unit":"px","size":1366,"sizes":[]},"padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"z_index":0,"width":{"unit":"%","size":100,"sizes":[]},"content_width":"full","min_height":{"unit":"px","size":220,"sizes":[]},"border_radius":{"unit":"px","top":"0","right":"0","bottom":"20","left":"20","isLinked":false},"_flex_size":"grow","min_height_tablet":{"unit":"px","size":200,"sizes":[]},"background_position_tablet":"center center","background_image_mobile":{"url":"","id":"","size":"","alt":"","source":"library"},"background_position_mobile":"bottom right","min_height_mobile":{"unit":"px","size":150,"sizes":[]}},"elements":[],"isInner":true}],"isInner":true}],"isInner":false},{"id":"2f1a1d65","elType":"container","settings":{"flex_direction":"row","flex_gap":{"unit":"px","size":20,"column":"20","row":"0"},"flex_align_items":"stretch","margin":{"unit":"px","top":"0","right":"0","bottom":"20","left":"0","isLinked":false},"flex_direction_tablet":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false}},"elements":[{"id":"8b07514","elType":"container","settings":{"flex_direction":"column","content_width":"full","width":{"unit":"%","size":"50"},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"5e177196","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"40","right":"32","bottom":"40","left":"32","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"020","bottom":"30","left":"020","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false},"min_height":{"unit":"custom","size":"100%","sizes":[]},"min_height_tablet":{"unit":"custom","size":"","sizes":[]},"min_height_mobile":{"unit":"custom","size":"","sizes":[]},"flex_justify_content":"space-around"},"elements":[{"id":"2749cd7f","elType":"widget","settings":{"__dynamic__":{"title":"[elementor-tag id=\"\" name=\"post-title\" settings=\"%7B%22before%22%3A%22%22%2C%22after%22%3A%22%22%2C%22fallback%22%3A%22%22%7D\"]"},"title":"Add Your Heading Text Here","typography_typography":"custom","typography_font_family":"Poppins","typography_font_size":{"unit":"px","size":28,"sizes":[]},"typography_font_weight":"500"},"elements":[],"widgetType":"theme-post-title"},{"id":"7755013d","elType":"widget","settings":{"editor":"<div data-testid=\"markdown-response\"><p id=\"message\">As part of an independent <strong>GxP Friendly Audit<\/strong>, the <strong>SaaS platform Ledidi Trials<\/strong> was comprehensively evaluated by DHC. The objective was the structured, transparent, and risk-based assessment of its regulatory suitability for use in GxP-regulated clinical trials.<\/p><\/div>","__globals__":{"typography_typography":"globals\/typography?id=538daf9","text_color":""}},"elements":[],"widgetType":"text-editor"},{"id":"17a14cbf","elType":"widget","settings":{"source":"custom","author_avatar":{"id":5872,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/Thomas-Pauly.webp","alt":"","source":"library","size":""},"show_name":"","author_name":"Thomas Pauly, Practice Manager, DHC GmbH","show_biography":"","author_bio":"","link_text":"All Posts","alignment":"left","image_size":{"unit":"px","size":70,"sizes":[]},"image_gap":{"unit":"px","size":12,"sizes":[]},"image_border_width":{"unit":"px","size":5,"sizes":[]},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_border_border":"none","_border_width":{"unit":"px","top":"5","right":"5","bottom":"5","left":"5","isLinked":true},"__globals__":{"_border_color":"globals\/colors?id=primary","image_border_color":""},"image_size_mobile":{"unit":"px","size":55,"sizes":[]},"author_name_tag":"div","image_border_color":"#FEFEFE","_border_color":"#0C693F","name_typography_typography":"custom","name_typography_font_family":"Poppins","name_typography_font_size":{"unit":"px","size":18,"sizes":[]},"name_typography_font_weight":"600","layout":"left"},"elements":[],"widgetType":"author-box"}],"isInner":true}],"isInner":true},{"id":"6194c5a2","elType":"container","settings":{"flex_direction":"column","content_width":"full","width":{"unit":"%","size":"50"},"min_height":{"unit":"custom","size":"100%","sizes":[]},"min_height_tablet":{"unit":"custom","size":"","sizes":[]},"min_height_mobile":{"unit":"custom","size":"","sizes":[]},"flex_justify_content":"space-between","width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"30","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"571a5a01","elType":"widget","settings":{"__dynamic__":{"image":"[elementor-tag id=\"\" name=\"post-featured-image\" settings=\"%7B%22fallback%22%3A%7B%22url%22%3A%22https%3A%2F%2Fdhc.ima.vc%2Fwp-content%2Fuploads%2F2026%2F03%2Fdiscovery-phase-sap-transformation-systemlandschaft-analyse.webp%22%2C%22id%22%3A5421%2C%22size%22%3A%22%22%2C%22alt%22%3A%22SAP%20Discovery-Phase%20mit%20Analyse%20der%20bestehenden%20Systemlandschaft%20und%20Integrationen%22%2C%22source%22%3A%22library%22%7D%7D\"]"},"image_size":"full","width":{"unit":"%","size":100,"sizes":[]},"space":{"unit":"%","size":100,"sizes":[]},"height":{"unit":"px","size":500,"sizes":[]},"height_tablet":{"unit":"px","size":350,"sizes":[]},"height_mobile":{"unit":"px","size":250,"sizes":[]},"object-fit":"cover","object-fit_tablet":"cover","object-position_tablet":"center center","image_border_radius":{"unit":"px","top":"30","right":"30","bottom":"30","left":"30","isLinked":true},"caption_typography_line_height":{"unit":"em","size":"","sizes":[]},"caption_typography_word_spacing":{"unit":"em","size":"","sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_background_gradient_position_tablet":"center center","_background_gradient_position_mobile":"center center","_background_hover_gradient_position_tablet":"center center","_background_hover_gradient_position_mobile":"center center","image":{"id":2618,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/12\/placeholder-1.png"}},"elements":[],"widgetType":"theme-post-featured-image"}],"isInner":true}],"isInner":false},{"id":"49e17216","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"7989692a","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"4ab08e4a","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">The article shows how audit results can be used as supplier evidence for <strong>risk-based supplier qualification<\/strong>, and that the audit does not replace internal <a href=\"https:\/\/dhc.ima.vc\/gxp-compliance\/softwarevalidierung\/\"><strong>validation (CSV\/CSA)<\/strong><\/a>, but typically significantly accelerates and streamlines it.<\/p><p style=\"text-align: left;\">The regulatory assessment of SaaS platforms intended for use in GxP-relevant processes is of high importance. Cloud-based solutions in particular place the focus on topics such as data integrity, electronic signatures, IT security, and supplier qualification.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"f944eeb","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"2871744","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"49ea18a","elType":"widget","settings":{"title":"What is a GxP-Friendly Audit?\n","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"41fe603","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">A GxP Friendly Audit is an <strong>independent, preparatory audit without formal inspection function<\/strong>.<\/p><p style=\"text-align: left;\"><strong>It serves to:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Assess the regulatory maturity of a system or SaaS provider<\/li><li>Identify possible compliance risks and, optionally, provide recommendations for action<\/li><li>Support risk-based supplier qualification<\/li><li>Prepare for customer audits or regulatory inspections<\/li><\/ul><p style=\"text-align: left;\">Unlike traditional supplier audits, the focus here is on the supportive, structured analysis of GxP readiness.<\/p><p style=\"text-align: left;\">Especially for SaaS providers in regulated environments, a Friendly Audit is a strategic instrument for GxP compliance.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"start","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"4abd488","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"b97ffdf","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"26e241f","elType":"widget","settings":{"title":"About Ledidi Trials","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"655cda3","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\"><a href=\"https:\/\/ledidi.com\/platform\/features\/platform-features-trials-module\" target=\"_blank\" rel=\"noopener\"><img class=\"alignright wp-image-11372 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/ledidi.webp\" alt=\"Logo of Ledidi, provider of clinical data and research software\" width=\"300\" height=\"157\" \/><\/a>Ledidi is a technology company focused on digital solutions for data-driven clinical research. The goal is to enable sponsors, CROs, and study teams to plan, conduct, and evaluate studies more efficiently through modern software approaches.<\/p><p style=\"text-align: left;\">With Ledidi Trials, the company offers a <strong>SaaS-based platform supporting clinical study processes<\/strong>. Key focus areas include:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Structured data processing<\/li><li>Collaborative work processes<\/li><li>Transparency between study participants<\/li><li>Digital support of regulatory requirements<\/li><\/ul><p style=\"text-align: left;\">The solution is designed for use in regulated clinical research environments and is continuously developed to meet current regulatory and industry requirements.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"3b052d1","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"86dc434","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"07124c9","elType":"widget","settings":{"title":"Audit Approach and Regulatory Framework\n","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"1fcd44c","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">The audit was conducted as an independent, risk-based GxP Friendly Audit aligned with international regulatory requirements and guidelines, including:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures)<\/li><li>ICH GCP E6(R3)<\/li><li>ISPE GAMP 5 (risk-based approach for computerized systems)<\/li><\/ul><p style=\"text-align: left;\">The focus was on a supplier-side assessment of:<\/p><ul class=\"check-list\"><li style=\"text-align: left;\">Adequacy of the quality management system<\/li><li style=\"text-align: left;\">Effectiveness of development and control mechanisms<\/li><li style=\"text-align: left;\">Suitability of operational processes<\/li><li style=\"text-align: left;\">Suitability for use in GxP-regulated clinical trials<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"a186792","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"2a6a54a","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"64385fb","elType":"widget","settings":{"title":"Scope of the GxP Audit for the SaaS Platform\n","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"9de4a88","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">The audit covered the following central areas:<\/p><p style=\"text-align: left;\"><strong>Quality Management System (QMS)<\/strong><\/p><ul style=\"text-align: left;\"><li>Structure and documentation<\/li><li>Roles and responsibility models<\/li><li>CAPA and change management<\/li><\/ul><p style=\"text-align: left;\"><strong>Software Development Lifecycle (SDLC)<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Development processes<\/li><li>Agile methods and documentation<\/li><li>Traceability and accountability<\/li><\/ul><p style=\"text-align: left;\"><strong>Release and Change Management<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Formalized release processes<\/li><li>Controlled version management<\/li><li>Impact and risk analyses<\/li><\/ul><p style=\"text-align: left;\"><strong>SaaS Operations and IT Security<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Access controls<\/li><li>Role-based authorization<\/li><li>Electronic signatures<\/li><li>Data security measures<\/li><\/ul><p style=\"text-align: left;\"><strong>Data Integrity and Business Continuity<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Backup strategies<\/li><li>Disaster recovery<\/li><li>Business continuity management<\/li><li>Audit trails<\/li><li>Ensuring ALCOA+ principles<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"4d5792e","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"84118aa","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"3882fbe","elType":"widget","settings":{"title":"Audit Results","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"80391f8","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">The independent Friendly Audit confirmed that Ledidi Trials has implemented a <strong>comprehensive and structured quality system<\/strong>.<\/p><p style=\"text-align: left;\">The final audit report contains <strong>no open deviations<\/strong> and confirms the platform's fundamental readiness for use in GxP-regulated clinical trials.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"e86d2a2","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"ffbb15e","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"85b56d1","elType":"widget","settings":{"selected_icon":{"value":"fas fa-quote-left","library":"fa-solid"},"align":"start","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"_flex_align_self":"center"},"elements":[],"widgetType":"icon"},{"id":"4611133","elType":"widget","settings":{"editor":"<p><em>\"The Friendly Audit conducted by DHC and the resulting report provided us with inspection-ready evidence on electronic records and signatures, audit trails, and traceability, aligned with recognized regulatory expectations. This made sponsor discussions and vendor qualification reviews significantly easier and more efficient.\"<\/em><\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=text","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"_background_color_stop_tablet":{"unit":"%"},"_background_color_stop_mobile":{"unit":"%"},"_background_color_b_stop_tablet":{"unit":"%"},"_background_color_b_stop_mobile":{"unit":"%"},"_background_gradient_angle_tablet":{"unit":"deg"},"_background_gradient_angle_mobile":{"unit":"deg"},"_background_hover_color_stop_tablet":{"unit":"%"},"_background_hover_color_stop_mobile":{"unit":"%"},"_background_hover_color_b_stop_tablet":{"unit":"%"},"_background_hover_color_b_stop_mobile":{"unit":"%"},"_background_hover_gradient_angle_tablet":{"unit":"deg"},"_background_hover_gradient_angle_mobile":{"unit":"deg"},"_flex_size":"none","_flex_align_self":"center"},"elements":[],"widgetType":"text-editor"},{"id":"9b1f80a","elType":"widget","settings":{"title":"Danckert Mellbye","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=538daf9","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":90,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"header_size":"div","_element_width_mobile":"inherit","_background_color_stop_tablet":{"unit":"%"},"_background_color_stop_mobile":{"unit":"%"},"_background_color_b_stop_tablet":{"unit":"%"},"_background_color_b_stop_mobile":{"unit":"%"},"_background_gradient_angle_tablet":{"unit":"deg"},"_background_gradient_angle_mobile":{"unit":"deg"},"_background_hover_color_stop_tablet":{"unit":"%"},"_background_hover_color_stop_mobile":{"unit":"%"},"_background_hover_color_b_stop_tablet":{"unit":"%"},"_background_hover_color_b_stop_mobile":{"unit":"%"},"_background_hover_gradient_angle_tablet":{"unit":"deg"},"_background_hover_gradient_angle_mobile":{"unit":"deg"},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"aee0894","elType":"widget","settings":{"title":"Chief Operating Officer, Ledidi AS\n","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=e6d4d63","title_color":"globals\/colors?id=text"},"_element_custom_width_mobile":{"unit":"%","size":90,"sizes":[]},"title_color":"#444444","header_size":"div","_element_width_mobile":"inherit","_background_color_stop_tablet":{"unit":"%"},"_background_color_stop_mobile":{"unit":"%"},"_background_color_b_stop_tablet":{"unit":"%"},"_background_color_b_stop_mobile":{"unit":"%"},"_background_gradient_angle_tablet":{"unit":"deg"},"_background_gradient_angle_mobile":{"unit":"deg"},"_background_hover_color_stop_tablet":{"unit":"%"},"_background_hover_color_stop_mobile":{"unit":"%"},"_background_hover_color_b_stop_tablet":{"unit":"%"},"_background_hover_color_b_stop_mobile":{"unit":"%"},"_background_hover_gradient_angle_tablet":{"unit":"deg"},"_background_hover_gradient_angle_mobile":{"unit":"deg"},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"}],"isInner":true}],"isInner":false},{"id":"de129ac","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"9f45285","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"57c00d5","elType":"widget","settings":{"title":"Use of the Audit Results for Supplier Qualification","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"d6b7c04","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">The audit results can be used by sponsors and CROs as part of risk-based supplier qualification according to ISPE GAMP 5.<\/p><p style=\"text-align: left;\"><strong>Important:<\/strong><\/p><p style=\"text-align: left;\">The responsibility for system validation and intended use remains with the regulated organization at all times.<\/p><p style=\"text-align: left;\">However, a GxP Friendly Audit significantly supports:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Reduction of qualification effort<\/li><li>Increased transparency for sponsors<\/li><li>Acceleration of contract and selection processes<\/li><li>Strengthening of the compliance position<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"5476352","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"33f016f","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"9826057","elType":"widget","settings":{"title":"Why are GxP-Friendly Audits strategically important for SaaS Providers?\n","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"c2a810c","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Cloud and SaaS solutions in the life sciences environment are subject to specific regulatory requirements.<\/p><p style=\"text-align: left;\"><strong>Challenges include:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Division of responsibilities between provider and regulated organization<\/li><li>Validation of cloud-based systems<\/li><li>Ensuring data integrity<\/li><li>Auditability of agile development processes<\/li><li>Regulatory expectations for electronic systems<\/li><\/ul><p style=\"text-align: left;\"><strong>An independent GxP audit provides:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Regulatory transparency<\/li><li>Customer trust<\/li><li>Structured compliance evidence<\/li><li>Competitive advantages in the regulated market<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"e4a4c11","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"17e9917","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"ad8f3ee","elType":"widget","settings":{"title":"GxP-Friendly Audits for SaaS Providers in regulated Industries","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"2aca94e","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Are you planning to deploy a SaaS solution in GxP-regulated processes? Or would you like to have your regulatory maturity structurally assessed as a software provider?<\/p><p style=\"text-align: left;\"><strong>DHC Dr. Herterich &amp; Consultants supports you with:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>GxP Friendly Audits<\/li><li>Supplier qualification<\/li><li>CSV and CSA strategies<\/li><li>Regulatory assessments of cloud-based systems<\/li><li>Compliance optimization for digital platforms<\/li><\/ul><div style=\"text-align: left;\">More about DHC consulting services for <a href=\"https:\/\/dhc.ima.vc\/en\/gxp-compliance\/audit-readiness\/\"><strong>Audit Readiness <\/strong><span style=\"text-align: center; font-size: 17.3884px;\"><b>\u2192<\/b><\/span><\/a><\/div>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"1aac793a","elType":"container","settings":{"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"__globals__":{"background_overlay_color":"globals\/colors?id=aaddc3b","background_color":"globals\/colors?id=9b310c9"},"margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"_title":"CTA","margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"41223ab3","elType":"container","settings":{"flex_direction":"row","boxed_width":{"unit":"px","size":1280,"sizes":[]},"flex_justify_content":"space-evenly","flex_align_items":"center","background_background":"classic","background_image":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/achivements_background.webp","id":14413,"size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"50","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false},"content_width":"full","width":{"unit":"%","size":100},"padding_tablet":{"unit":"px","top":"40","right":"20","bottom":"40","left":"20","isLinked":false},"_element_width_none":"initial","width_none":{"size":681.6},"_element_width":"initial","flex_gap":{"column":"20","row":"0","isLinked":false,"unit":"px","size":20},"background_position":"center center","background_size":"cover","border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"__globals__":{"background_color":""},"flex_direction_tablet":"row","background_position_mobile":"center center","margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true}},"elements":[{"id":"1117cb89","elType":"container","settings":{"flex_direction":"column","boxed_width":{"unit":"px","size":1280,"sizes":[]},"background_background":"classic","background_image":{"url":"","id":"","size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"content_width":"full","width":{"unit":"%","size":70},"padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_flex_size":"none","_element_width_none":"initial","width_none":{"size":681.6},"_element_width":"initial","flex_gap":{"column":"10","row":"10","isLinked":false,"unit":"px","size":10},"_flex_align_self":"center","width_mobile":{"unit":"%","size":"","sizes":[]},"flex_gap_mobile":{"column":"15","row":"15","isLinked":true,"unit":"px","size":15},"flex_gap_tablet":{"column":"15","row":"15","isLinked":true,"unit":"px","size":15}},"elements":[{"id":"7571e62","elType":"widget","settings":{"title":"GxP-Friendly Audits for SaaS providers in regulated industries","align":"start","_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"10","left":"0","isLinked":false},"_element_width":"inherit","_element_custom_width":{"unit":"%","size":91,"sizes":[]},"__globals__":{"typography_typography":""},"_element_custom_width_tablet":{"unit":"%","size":80,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"_padding_mobile":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"_flex_size":"none","_element_width_none":"initial","_element_custom_width_none":{"size":491.025},"align_mobile":"center","typography_typography":"custom","typography_font_family":"Poppins","typography_font_size":{"unit":"custom","size":"clamp(1.125rem, 0.6389rem + 1.5556vw, 2rem)","sizes":[]},"typography_font_weight":"400","typography_line_height":{"unit":"custom","size":"120%","sizes":[]},"typography_line_height_mobile":{"unit":"custom","size":"120%","sizes":[]}},"elements":[],"widgetType":"heading"},{"id":"1fc7341d","elType":"widget","settings":{"editor":"Are you preparing for a Supplier or SaaS Audit?","__globals__":{"typography_typography":"globals\/typography?id=text"},"align":"start","_element_width":"initial","_element_custom_width":{"unit":"%","size":80,"sizes":[]},"align_mobile":"center","_element_width_mobile":"inherit","_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]}},"elements":[],"widgetType":"text-editor"},{"id":"4b9cfc72","elType":"widget","settings":{"text":"Book a free Initial Consultation","border_border":"solid","border_width":{"unit":"px","top":"1","right":"1","bottom":"1","left":"1","isLinked":true},"__globals__":{"button_background_hover_color":"globals\/colors?id=9b310c9","hover_color":"globals\/colors?id=accent","border_color":"globals\/colors?id=accent"},"link":{"url":"https:\/\/dhc.ima.vc\/en\/book-meeting\/","is_external":"","nofollow":"","custom_attributes":""},"button_text_color":"#FFFFFF","selected_icon":{"value":"fas fa-arrow-right","library":"fa-solid"},"icon_align":"row-reverse","icon_indent":{"unit":"px","size":19,"sizes":[]},"align_mobile":"center","_flex_align_self":"flex-start","_flex_align_self_mobile":"center","_css_classes":"custom-button"},"elements":[],"widgetType":"button"}],"isInner":true},{"id":"293cbc43","elType":"container","settings":{"flex_direction":"column","boxed_width":{"unit":"px","size":1280,"sizes":[]},"flex_align_items":"center","background_background":"classic","background_image":{"url":"","id":"","size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"content_width":"full","width":{"unit":"custom","size":"fit-content","sizes":[]},"width_tablet":{"unit":"custom","size":"","sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"boxed_width_mobile":{"unit":"px","size":0,"sizes":[]},"flex_direction_mobile":"column-reverse","_flex_order_mobile":"start"},"elements":[{"id":"68de9688","elType":"widget","settings":{"source":"custom","author_avatar":{"id":2987,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/karsten-schulz-dhc-experte.webp","alt":"","source":"library","size":""},"show_name":"","author_name":"","show_biography":"","show_link":"","author_bio":"","link_text":"All Articles","image_size":{"unit":"px","size":170,"sizes":[]},"image_gap":{"unit":"px","size":0,"sizes":[]},"image_border_color":"#FFFFFF","image_border_width":{"unit":"px","size":15,"sizes":[]},"image_border_radius":{"unit":"px","size":100,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_z_index":5,"_offset_x":{"size":55,"unit":"px"},"image_size_mobile":{"unit":"px","size":80,"sizes":[]},"_offset_y":{"size":0,"unit":"px"},"_title":"Autor Box","image_vertical_align":"middle","image_size_tablet":{"unit":"px","size":140,"sizes":[]},"image_gap_mobile":{"unit":"px","size":0,"sizes":[]},"button_text_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[],"widgetType":"author-box"}],"isInner":true}],"isInner":true}],"isInner":true},{"id":"28880ae3","elType":"container","settings":{"flex_direction":"column","margin":{"unit":"px","top":"0","right":"0","bottom":"120","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"_title":"FAQ","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false}},"elements":[{"id":"2a20d850","elType":"widget","settings":{"title":"FAQs","align":"center","_padding":{"unit":"px","top":"10","right":"20","bottom":"10","left":"20","isLinked":false},"_flex_align_self":"center","_background_background":"gradient","_background_color_b":"","_border_radius":{"unit":"px","top":"50","right":"50","bottom":"50","left":"50","isLinked":true},"__globals__":{"typography_typography":"globals\/typography?id=secondary","title_color":"globals\/colors?id=9b310c9","_background_color":"globals\/colors?id=accent"},"header_size":"div","_margin":{"unit":"px","top":"40","right":"0","bottom":"15","left":"0","isLinked":false}},"elements":[],"widgetType":"heading"},{"id":"18ce6bf5","elType":"widget","settings":{"title":"Frequently asked Questions about GxP-Friendly Audits for SaaS Providers (FAQ)\n","align":"center","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_flex_align_self":"center","__globals__":{"typography_typography":"globals\/typography?id=42dac7a"},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]}},"elements":[],"widgetType":"heading"},{"id":"44e5fd59","elType":"container","settings":{"content_width":"full","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"40","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"7aa4d553","elType":"widget","widgetType":"nested-accordion","settings":{"items":[{"item_title":"What is a \u201cGxP-Friendly Audit\u201d for SaaS Platforms \u2013 and how does it differ from a traditional Supplier or IT Audit?","_id":"a8c5d3b"},{"item_title":"Which Regulations and Guidelines does a GxP-Friendly SaaS Audit typically address?","_id":"4af6865"},{"item_title":"Which Audit Areas are most important in a GxP-Friendly Audit for SaaS?","_id":"c5d09d8"},{"item_title":"Which Evidence and Documentation are accepted in a GxP-Friendly Audit for SaaS?","_id":"94b6375"},{"item_title":"Can a GxP-Friendly Audit replace Validation (CSV\/CSA)?","_id":"970963c"}],"accordion_item_title_position_horizontal":"stretch","accordion_item_title_icon_position":"end","accordion_item_title_icon":{"value":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/12\/plus_icon.svg","id":1859},"library":"svg"},"accordion_item_title_icon_active":{"value":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/12\/minus_icon.svg","id":1858},"library":"svg"},"accordion_item_title_space_between":{"unit":"px","size":20,"sizes":[]},"accordion_background_normal_background":"classic","accordion_border_normal_border":"none","accordion_border_radius":{"unit":"px","top":"30","right":"30","bottom":"30","left":"30","isLinked":false},"accordion_padding":{"unit":"px","top":"20","right":"30","bottom":"20","left":"30","isLinked":false},"icon_size":{"unit":"px","size":32,"sizes":[]},"normal_icon_color":"#80636300","hover_icon_color":"#02010100","active_icon_color":"#02010100","content_border_border":"none","content_border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"content_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_element_width":"initial","_element_custom_width":{"unit":"%","size":80,"sizes":[]},"_flex_align_self":"center","__globals__":{"accordion_background_normal_color":"globals\/colors?id=aaddc3b","title_typography_typography":"globals\/typography?id=538daf9","normal_title_color":"globals\/colors?id=secondary","hover_title_color":"globals\/colors?id=secondary","active_title_color":"globals\/colors?id=secondary"},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"title_typography_typography":"custom","title_typography_font_family":"Poppins","title_typography_font_size":{"unit":"custom","size":"clamp(0.875rem, 0.8056rem + 0.2222vw, 1rem)","sizes":[]},"title_typography_font_weight":"400","title_typography_line_height":{"unit":"custom","size":"160%","sizes":[]},"hover_title_color":"#0C693F","active_title_color":"#0C693F","default_state":"all_collapsed"},"elements":[{"id":"36557191","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"463d48e","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"46a5d711","elType":"widget","settings":{"editor":"<p>A GxP Friendly Audit is a risk-based, SaaS-ready supplier\/platform audit that specifically examines the controls critical for GxP compliance and auditability (e.g., data integrity, access controls, change\/release, incident\/DR). It takes into account the cloud reality (multi-tenant, standard product, frequent releases, limited individual audit access).<\/p><p><strong>Differences from a traditional audit:<\/strong><\/p><ul><li><strong>Shared Responsibility<\/strong> in focus: Clear delineation of what the SaaS provider is responsible for and what the customer must ensure organizationally\/procedurally.<\/li><li><strong>Evidence pragmatic<\/strong>: Uses realistic SaaS evidence (e.g., SOC\/ISO, trust center artifacts) rather than expecting \"on-prem\" artifacts that SaaS often cannot provide.<\/li><li><strong>GxP impact<\/strong> instead of full coverage: Preferably examines GxP-critical areas rather than \"everything theoretically possible.\"<\/li><li><strong>Decision-oriented:<\/strong> Delivers a go\/no-go-ready assessment including conditions and action plan.<\/li><\/ul>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"30dabbe8","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"419e22f6","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"5568af38","elType":"widget","settings":{"editor":"<p>A GxP Friendly Audit typically \"maps\" SaaS controls to the regulatory expectations around computerized systems and data integrity. Common references include:<\/p><ul><li><strong>EU GMP including Annex 11<\/strong>: Expectations regarding operations, security, data integrity, audit trails, supplier management, changes.<\/li><li><strong>GAMP 5<\/strong>: Guideline for risk-based approach, supplier assessment, appropriate verification\/validation.<\/li><li><strong>FDA 21 CFR Part 11<\/strong> (if applicable): Requirements for electronic records and electronic signatures.<\/li><li><strong>Data Integrity (ALCOA+)<\/strong> as guiding principle: Traceability, completeness, immutability, availability.<\/li><\/ul><p>Important for decision-makers:<br \/>Not every SaaS usage is automatically \"Part 11-critical.\" Relevance strongly depends on whether the platform creates\/manages GxP records and whether electronic signatures are used.<\/p>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"2b933db4","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"77fefc68","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"8239be5","elType":"widget","settings":{"editor":"<p>The most important audit focus areas are the controls that directly affect data integrity, compliance traceability, and operational security:<\/p><p><strong>Audit Trail &amp; Data Integrity<\/strong><\/p><ul><li>Is the audit trail complete (who\/what\/when\/why), activatable\/configurable, protectable, and evaluable?<\/li><li>Can records\/audit trails be exported and used long-term for audits?<\/li><\/ul><p><strong>Identity &amp; Access Management (IAM)<\/strong><\/p><ul class=\"check-list\"><li>Role\/authorization concept (RBAC), least privilege, admin controls<\/li><li>MFA\/SSO, user lifecycle (joiner\/mover\/leaver), recertifications<\/li><\/ul><p><strong>Change &amp; Release Management (SaaS Updateability)<\/strong><\/p><ul><li>How are changes tested, approved, and communicated?<\/li><li>Are there impact assessments, release notes, possibly feature toggles\/configurable functions?<\/li><\/ul><p><strong>Backup\/Restore &amp; Business Continuity \/ Disaster Recovery<\/strong><\/p><ul><li>Defined RPO\/RTO, restore tests, evidence of DR exercises<\/li><li>Availability &amp; recoverability of GxP-critical data<\/li><\/ul><p><strong>Incident, Problem &amp; Vulnerability Management<\/strong><\/p><ul><li>Reporting processes, SLAs, RCA, CAPA mechanisms<\/li><li>Patch\/vulnerability handling, security monitoring<\/li><\/ul><p>Additionally often decisive: Data location\/subprocessor transparency, logging\/monitoring, interfaces &amp; integrations, configuration control.<\/p>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"6047a741","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"5b87de1e","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"4f29af84","elType":"widget","settings":{"editor":"<p>Accepted evidence typically includes standardized, audited proof and process artifacts that demonstrate the effectiveness of controls, e.g.:<\/p><ul><li><strong>SOC 2 Type II<\/strong> (including scope\/period and tested controls)<\/li><li><strong>ISO 27001 certification<\/strong> (plus relevant annexes\/scope, possibly Statement of Applicability)<\/li><li><strong>Trust Center \/ Compliance Portal<\/strong> (policies, process descriptions, control overviews)<\/li><li><strong>SDLC\/change process evidence<\/strong> (release notes, change workflows, test summaries)<\/li><li><strong>BCP\/DR evidence<\/strong> (DR test reports, results, improvement measures)<\/li><li><strong>Incident\/security evidence<\/strong> (process, ticket\/RCA examples in anonymized form)<\/li><li><strong>Subprocessor lists &amp; Data Processing Agreements (DPA)<\/strong>, data flow\/architecture overviews<\/li><\/ul>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"4c981568","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"1e630a21","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"5153330f","elType":"widget","settings":{"editor":"<p>A GxP Friendly Audit typically does not fully replace an internal customer validation, but it can significantly streamline and accelerate it.<\/p><p>What the audit typically delivers:<\/p><ul><li>Verifies the <strong>provider controls<\/strong> (e.g., security, ops, SDLC) as a reliable basis for supplier qualification<\/li><li>Provides input for <strong>CSA\/CSV scope<\/strong>: What can be adopted as \"supplier evidence,\" and what must the customer test themselves?<\/li><li>Creates a <strong>shared responsibility matrix<\/strong> that derives clear customer actions (SOPs, role model, periodic review, configuration control)<\/li><\/ul>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true}]}],"isInner":true}],"isInner":false},{"id":"643854bd","elType":"container","settings":{"flex_direction":"column","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"margin":{"unit":"px","top":"-50","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"20","bottom":"80","left":"20","isLinked":false},"_title":"Weitere Artikel","margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"75","right":"20","bottom":"75","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"50","right":"20","bottom":"50","left":"20","isLinked":false},"flex_justify_content":"center"},"elements":[{"id":"4fd289b3","elType":"widget","settings":{"title":"Magazine","_margin":{"unit":"px","top":"0","right":"0","bottom":"20","left":"0","isLinked":false},"_padding":{"unit":"px","top":"8","right":"13","bottom":"8","left":"13","isLinked":false},"_flex_align_self":"center","_background_background":"gradient","_background_color_b":"","_border_radius":{"unit":"px","top":"100","right":"100","bottom":"100","left":"100","isLinked":true},"__globals__":{"title_color":"globals\/colors?id=9b310c9","_background_color":"globals\/colors?id=accent","typography_typography":"globals\/typography?id=secondary"},"header_size":"div"},"elements":[],"widgetType":"heading"},{"id":"52106f4c","elType":"widget","settings":{"title":"More Articles from the Blog","align":"center","_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a"},"_element_custom_width_tablet":{"unit":"%","size":80,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"_padding_mobile":{"unit":"px","top":"10","right":"0","bottom":"20","left":"0","isLinked":false},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"25940306","elType":"widget","settings":{"template_id":2842,"alternate_templates":[{"template_id":null,"_id":"de51286"}],"pagination_page_limit":"5","pagination_prev_label":"Voriger","pagination_next_label":"N\u00e4chster","text":"Load More","load_more_no_posts_custom_message":"No more posts to show","nothing_found_message_text":"It seems we can\u2019t find what you\u2019re looking for.","columns_tablet":1,"posts_per_page":3,"equal_height":"yes","_padding":{"unit":"px","top":"60","right":"0","bottom":"60","left":"0","isLinked":false}},"elements":[],"widgetType":"loop-grid"}],"isInner":false}],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials<\/title>\n<meta name=\"description\" content=\"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials\" \/>\n<meta property=\"og:description\" content=\"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/\" \/>\n<meta property=\"og:site_name\" content=\"DHC Consulting\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-23T11:39:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-09T21:51:45+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"350\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"kdemmer\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"kdemmer\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/\"},\"author\":{\"name\":\"kdemmer\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#\\\/schema\\\/person\\\/baadfb23f56889296f29ae6c48ec5b83\"},\"headline\":\"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials\",\"datePublished\":\"2026-03-23T11:39:57+00:00\",\"dateModified\":\"2026-05-09T21:51:45+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/\"},\"wordCount\":1920,\"publisher\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"articleSection\":[\"GxP Compliance \\\/ CSV\",\"GxP Compliance \\\/ CSV\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/\",\"name\":\"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"datePublished\":\"2026-03-23T11:39:57+00:00\",\"dateModified\":\"2026-05-09T21:51:45+00:00\",\"description\":\"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#primaryimage\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"contentUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"width\":1200,\"height\":350,\"caption\":\"Two people in lab attire looking at a tablet \u2014 symbolizing the evaluation of a GxP-compliant SaaS platform for clinical trials.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/gxp-friendly-audit-for-saas-platform\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/beispiel-seite\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/\",\"name\":\"DHC Consulting\",\"description\":\"Beratungshaus f\u00fcr SAP Life Sciences, Qualit\u00e4tsmanagement und GxP Compliance\",\"publisher\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#organization\",\"name\":\"DHC Consulting\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/Logo.svg\",\"contentUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/Logo.svg\",\"width\":125,\"height\":31,\"caption\":\"DHC Consulting\"},\"image\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/en\\\/#\\\/schema\\\/person\\\/baadfb23f56889296f29ae6c48ec5b83\",\"name\":\"kdemmer\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials","description":"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"en_US","og_type":"article","og_title":"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials","og_description":"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.","og_url":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/","og_site_name":"DHC Consulting","article_published_time":"2026-03-23T11:39:57+00:00","article_modified_time":"2026-05-09T21:51:45+00:00","og_image":[{"width":1200,"height":350,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","type":"image\/webp"}],"author":"kdemmer","twitter_card":"summary_large_image","twitter_misc":{"Written by":"kdemmer","Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#article","isPartOf":{"@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/"},"author":{"name":"kdemmer","@id":"https:\/\/dhc.ima.vc\/en\/#\/schema\/person\/baadfb23f56889296f29ae6c48ec5b83"},"headline":"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials","datePublished":"2026-03-23T11:39:57+00:00","dateModified":"2026-05-09T21:51:45+00:00","mainEntityOfPage":{"@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/"},"wordCount":1920,"publisher":{"@id":"https:\/\/dhc.ima.vc\/en\/#organization"},"image":{"@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#primaryimage"},"thumbnailUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","articleSection":["GxP Compliance \/ CSV","GxP Compliance \/ CSV"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/","url":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/","name":"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials","isPartOf":{"@id":"https:\/\/dhc.ima.vc\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#primaryimage"},"image":{"@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#primaryimage"},"thumbnailUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","datePublished":"2026-03-23T11:39:57+00:00","dateModified":"2026-05-09T21:51:45+00:00","description":"Read the blog article to learn how DHC comprehensively evaluated the SaaS platform Ledidi Trials as part of an independent GxP-friendly audit.","breadcrumb":{"@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#primaryimage","url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","contentUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","width":1200,"height":350,"caption":"Two people in lab attire looking at a tablet \u2014 symbolizing the evaluation of a GxP-compliant SaaS platform for clinical trials."},{"@type":"BreadcrumbList","@id":"https:\/\/dhc.ima.vc\/en\/gxp-friendly-audit-for-saas-platform\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Start","item":"https:\/\/dhc.ima.vc\/en\/beispiel-seite\/"},{"@type":"ListItem","position":2,"name":"GxP Friendly Audit for Ledidi Trials: SaaS Platform for regulated Clinical Trials"}]},{"@type":"WebSite","@id":"https:\/\/dhc.ima.vc\/en\/#website","url":"https:\/\/dhc.ima.vc\/en\/","name":"DHC Consulting","description":"Beratungshaus f\u00fcr SAP Life Sciences, Qualit\u00e4tsmanagement und GxP Compliance","publisher":{"@id":"https:\/\/dhc.ima.vc\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/dhc.ima.vc\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/dhc.ima.vc\/en\/#organization","name":"DHC Consulting","url":"https:\/\/dhc.ima.vc\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/dhc.ima.vc\/en\/#\/schema\/logo\/image\/","url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/Logo.svg","contentUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/Logo.svg","width":125,"height":31,"caption":"DHC Consulting"},"image":{"@id":"https:\/\/dhc.ima.vc\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/dhc.ima.vc\/en\/#\/schema\/person\/baadfb23f56889296f29ae6c48ec5b83","name":"kdemmer"}]}},"_links":{"self":[{"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/posts\/12544","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/comments?post=12544"}],"version-history":[{"count":0,"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/posts\/12544\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/media\/13526"}],"wp:attachment":[{"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/media?parent=12544"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/categories?post=12544"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dhc.ima.vc\/en\/wp-json\/wp\/v2\/tags?post=12544"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}