{"id":10716,"date":"2026-04-28T15:40:25","date_gmt":"2026-04-28T13:40:25","guid":{"rendered":"https:\/\/www.dhc-consulting.com\/en\/?page_id=10716"},"modified":"2026-05-06T10:49:42","modified_gmt":"2026-05-06T08:49:42","slug":"ai-self-assessment-2","status":"publish","type":"page","link":"https:\/\/www.dhc-consulting.com\/en\/ai-self-assessment-2\/","title":{"rendered":"AI Self Assessment"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10716\" class=\"elementor elementor-10716\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c524869 e-flex e-con-boxed e-con e-parent\" data-id=\"c524869\" 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-2bfecc9 elementor-widget elementor-widget-shortcode\" data-id=\"2bfecc9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">        <form method=\"post\" class=\"sa-frontend\">\r\n            <input type=\"hidden\" name=\"sa_assessment_id\" value=\"10714\">\r\n            <input type=\"hidden\" id=\"sa_submit_nonce\" name=\"sa_submit_nonce\" value=\"fd64846880\" \/><input type=\"hidden\" name=\"_wp_http_referer\" value=\"\/en\/wp-json\/wp\/v2\/pages\/10716\" \/>            <input type=\"text\" name=\"sa_honeypot\" style=\"display:none !important;\" tabindex=\"-1\" autocomplete=\"off\">\r\n\r\n            \r\n                                                <!-- Textabschnitt -->\r\n                    <br>\r\n                    <div class=\"sa-fq\" style=\"background: transparent; box-shadow: none; padding: 0;\">\r\n                        <p style=\"margin: 0;\"><strong>Strategy &amp; Concept<\/strong><\/p>\r\n                    <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Do AI use cases already exist in your organization?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_1\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_1\" value=\"1\">\r\n                                Yes, but not GxP-relevant                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_1\" value=\"2\">\r\n                                Yes, but unclear whether GxP-relevant                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_1\" value=\"3\">\r\n                                Yes, clearly GxP-relevant                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Has the AI use case been assessed with regard to patient safety, product quality, and data integrity?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_2\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_2\" value=\"1\">\r\n                                Initial informal assessment                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_2\" value=\"2\">\r\n                                Structured risk assessment performed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_2\" value=\"3\">\r\n                                Risk assessment serves as a documented basis for decision-making                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is there a structured process for the evaluation and testing of AI ideas<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_3\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_3\" value=\"1\">\r\n                                Ad\u2011hoc testing without a formal framework                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_3\" value=\"2\">\r\n                                PoC process is defined                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_3\" value=\"3\">\r\n                                PoC process is established with defined evaluation criteria and transition into the project phase                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Textabschnitt -->\r\n                    <br>\r\n                    <div class=\"sa-fq\" style=\"background: transparent; box-shadow: none; padding: 0;\">\r\n                        <p style=\"margin: 0;\"><strong>Governance &amp; Organization<\/strong><\/p>\r\n                    <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are clear responsibilities defined for development, operation, and monitoring of the AI system?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_5\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_5\" value=\"1\">\r\n                                Implicitly distributed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_5\" value=\"2\">\r\n                                Roles are defined                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_5\" value=\"3\">\r\n                                Roles are formally anchored within the governance\/QMS framework                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is the use of AI organizationally and procedurally embedded in existing IT, quality, and validation structures?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_6\" value=\"0\">\r\n                                AI is considered in isolation                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_6\" value=\"1\">\r\n                                Initial points of integration exist                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_6\" value=\"2\">\r\n                                Partially integrated                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_6\" value=\"3\">\r\n                                Fully integrated                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is it defined which level of autonomy the AI system has and where human review is mandatory?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_7\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_7\" value=\"1\">\r\n                                Informally known                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_7\" value=\"2\">\r\n                                Levels of autonomy are defined for the use case                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_7\" value=\"3\">\r\n                                Levels of autonomy are documented and human\u2011in\u2011the\u2011loop requirements are operationally implemented                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Textabschnitt -->\r\n                    <br>\r\n                    <div class=\"sa-fq\" style=\"background: transparent; box-shadow: none; padding: 0;\">\r\n                        <p style=\"margin: 0;\"><strong>Data &amp; Model Quality<\/strong><\/p>\r\n                    <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are the origin, purpose, and quality of the data used for AI traceable?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_9\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_9\" value=\"1\">\r\n                                Partially known                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_9\" value=\"2\">\r\n                                Largely documented                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_9\" value=\"3\">\r\n                                Fully documented and traceable                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are data\u2011 or model\u2011related risks (e.g. bias, drift) consciously addressed?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_10\" value=\"0\">\r\n                                Not considered                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_10\" value=\"1\">\r\n                                Awareness exists                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_10\" value=\"2\">\r\n                                Risks are assessed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_10\" value=\"3\">\r\n                                Monitoring and mitigation measures are defined                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are AI results and decisions critically challenged and validated by subject matter experts (critical thinking)?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_11\" value=\"0\">\r\n                                No, AI results are accepted as is                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_11\" value=\"1\">\r\n                                Occasionally, depending on individuals                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_11\" value=\"2\">\r\n                                Systematic review is intended                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_11\" value=\"3\">\r\n                                Critical review is integrated into processes and training                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Textabschnitt -->\r\n                    <br>\r\n                    <div class=\"sa-fq\" style=\"background: transparent; box-shadow: none; padding: 0;\">\r\n                        <p style=\"margin: 0;\"><strong>Suppliers &amp; Transparency<\/strong><\/p>\r\n                    <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is responsibility between suppliers and operators clearly defined and taken into account in operations?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_13\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_13\" value=\"1\">\r\n                                Partially                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_13\" value=\"2\">\r\n                                Contractually regulated                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_13\" value=\"3\">\r\n                                Contractually regulated and operationally implemented                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is there sufficient transparency regarding changes to models, data, or AI functions made by suppliers?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_14\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_14\" value=\"1\">\r\n                                Limited                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_14\" value=\"2\">\r\n                                Documented information available                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_14\" value=\"3\">\r\n                                Auditable transparency in place                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Textabschnitt -->\r\n                    <br>\r\n                    <div class=\"sa-fq\" style=\"background: transparent; box-shadow: none; padding: 0;\">\r\n                        <p style=\"margin: 0;\"><strong>Lifecycle &amp; Operation<\/strong><\/p>\r\n                    <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is the AI system considered across its entire lifecycle (not only until go\u2011live)?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_16\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_16\" value=\"1\">\r\n                                Partially                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_16\" value=\"2\">\r\n                                Documented                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_16\" value=\"3\">\r\n                                Operationally implemented                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are performance indicators and monitoring criteria defined for ongoing operation?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_17\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_17\" value=\"1\">\r\n                                Roughly defined                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_17\" value=\"2\">\r\n                                Clearly defined                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_17\" value=\"3\">\r\n                                Defined including thresholds and response measures                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are there clear rules defining when adjustments, re\u2011training, or re\u2011validation are required?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_18\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_18\" value=\"1\">\r\n                                Discussed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_18\" value=\"2\">\r\n                                Defined                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_18\" value=\"3\">\r\n                                Anchored in SOPs \/ processes                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Is the IT infrastructure suitable for AI operation (e.g. data storage, model versioning, deployment)?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_19\" value=\"0\">\r\n                                Not assessed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_19\" value=\"1\">\r\n                                Basic infrastructure available                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_19\" value=\"2\">\r\n                                AI\u2011specific requirements have been identified and partially implemented                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_19\" value=\"3\">\r\n                                End\u2011to\u2011end MLOps \/ AI infrastructure established                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Textabschnitt -->\r\n                    <br>\r\n                    <div class=\"sa-fq\" style=\"background: transparent; box-shadow: none; padding: 0;\">\r\n                        <p style=\"margin: 0;\"><strong>Regulatory &amp; Competence<\/strong><\/p>\r\n                    <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Are transparency, traceability, and fairness of AI systematically considered?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_21\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_21\" value=\"1\">\r\n                                Generally considered                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_21\" value=\"2\">\r\n                                Assessed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_21\" value=\"3\">\r\n                                Integrated into governance and decision\u2011making processes                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                                                                <!-- Normal question -->\r\n                    <div class=\"sa-fq\">\r\n                        <p><strong>Has the relevance of regulatory requirements (e.g. EU AI Act, GDPR, GxP) for the use of AI been assessed?<\/strong><\/p>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_22\" value=\"0\">\r\n                                No                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_22\" value=\"1\">\r\n                                Uncertain                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_22\" value=\"2\">\r\n                                Assessed                            <\/label>\r\n                                                    <label class=\"sa-opt\">\r\n                                <input required type=\"radio\" name=\"sa_q_22\" value=\"3\">\r\n                                Measures have been derived                            <\/label>\r\n                                            <\/div>\r\n                    <hr>\r\n                            \r\n            <button type=\"submit\" class=\"sa-submit\">Evaluate<\/button>\r\n        <\/form>\r\n        <\/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\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-10716","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AI Self Assessment | EN - DHC Consulting<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AI Self Assessment | EN - DHC Consulting\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.dhc-consulting.com\/en\/ai-self-assessment-2\/\" \/>\n<meta property=\"og:site_name\" content=\"EN - DHC Consulting\" \/>\n<meta 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