{"id":64878,"date":"2023-08-01T14:52:00","date_gmt":"2023-08-01T14:52:00","guid":{"rendered":"https:\/\/kepner-tregoe.com\/about\/client-success-stories\/strategic-capa-process-assessment\/"},"modified":"2026-02-26T11:26:01","modified_gmt":"2026-02-26T11:26:01","slug":"strategic-capa-process-assessment","status":"publish","type":"client-success-story","link":"https:\/\/kepner-tregoe.com\/de\/about\/client-success-stories\/strategic-capa-process-assessment\/","title":{"rendered":"Strategische CAPA-Prozessbewertung in der Pharmaindustrie bringt wichtige Erkenntnisse"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-client\">Kunde<\/h2>\n\n<p class=\"wp-block-paragraph\">Ein f\u00fchrendes globales Pharmaunternehmen, das sich der weltweiten Verbesserung der Gesundheitsversorgung durch die Bereitstellung innovativer pharmazeutischer Produkte verschrieben hat. Ihr Engagement gilt der Verbesserung der Gesundheitsergebnisse und der Sicherstellung hochwertiger Gesundheitsl\u00f6sungen f\u00fcr Patienten und Gesundheitsdienstleister weltweit. <\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-goal\">Ziel<\/h2>\n\n<p class=\"wp-block-paragraph\">Der Kunde identifizierte mehrere zentrale Bed\u00fcrfnisse im Zusammenhang mit seinen Abweichungs- sowie Korrektur- und Vorbeugema\u00dfnahmen (CAPA)-Prozessen. Diese Bed\u00fcrfnisse umfassten: <\/p>\n\n<ul class=\"wp-block-list\">\n<li>Behebung des Problems, dass Abweichungen nicht innerhalb der regulatorischen Frist von 30 Tagen geschlossen werden.<\/li>\n\n\n\n<li>Verbesserung der P\u00fcnktlichkeit von CAPA-Abschl\u00fcssen, um die zeitnahe Umsetzung wirksamer Korrektur- und Vorbeugema\u00dfnahmen sicherzustellen.<\/li>\n\n\n\n<li>Verbesserung der Gesamteffektivit\u00e4t ihrer Korrektur- und Vorbeugema\u00dfnahmen (CAPA)-Prozesse.<\/li>\n<\/ul>\n\n<h2 class=\"wp-block-heading\" id=\"h-solution\">L\u00f6sung<\/h2>\n\n<p class=\"wp-block-paragraph\">Das KT-Team f\u00fchrte eine strategische Diagnose der Abweichungs- und CAPA-Prozesse der Organisation durch. Wir setzten datenwissenschaftliche Techniken ein und analysierten die Organisation anhand von vier Perspektiven, n\u00e4mlich Menschen, Prozesse, Technologie und Messung, um jeden Schritt des Prozesses, vom Auftreten der Abweichung bis zur CAPA-Implementierung, zu analysieren (siehe Abbildung 1). <\/p>\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/kepner-tregoe.com\/wp-content\/uploads\/2023\/07\/Picture1.png\" alt=\"Kepner-Tregoe Diagnose-Prozessablaufdiagramm\"\/><\/figure>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<p class=\"wp-block-paragraph\">Um ein umfassendes Verst\u00e4ndnis des aktuellen Zustands zu gewinnen, nutzten die Datenanalysten von Kepner-Tregoe fortschrittliche Datenanalyse- und <a href=\"https:\/\/vimeo.com\/836742957\" target=\"_\" blank=\"\">Process-Mining<\/a>-Techniken. Durch die Analyse von Abweichungen, CAPAs, Laboruntersuchungen und Beschwerden deckten sie verborgene Erkenntnisse und Optimierungsm\u00f6glichkeiten auf. Process Mining, eine leistungsstarke Technik zur Analyse und Verbesserung von Gesch\u00e4ftsprozessen, erm\u00f6glichte es dem KT-Kunden-Team, Engp\u00e4sse und Ineffizienzen zu identifizieren und datengest\u00fctzte Entscheidungen zur Prozessoptimierung zu treffen (siehe Beispiel in Abbildung 2).  <\/p>\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/kepner-tregoe.com\/wp-content\/uploads\/2023\/07\/Picture2.jpg\" alt=\"Beispiel einer Process-Mining-Datenvisualisierung\"\/><\/figure>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<p class=\"wp-block-paragraph\">Zus\u00e4tzlich zu den Data-Mining-Studien f\u00fchrte das Team Interviews, beobachtete Besprechungen sowie Verfahrens- und Richtlinien\u00fcberpr\u00fcfungen durch. Die Analyse lieferte wichtige Erkenntnisse durch die Betrachtung der bestehenden Abweichungs- und CAPA-Prozesse von Ende zu Ende. Es wurde eine sorgf\u00e4ltige Fallqualit\u00e4tspr\u00fcfung durchgef\u00fchrt, die die Dokumentationsqualit\u00e4t bewertete und Bereiche f\u00fcr Verbesserungen identifizierte.  <\/p>\n\n<p class=\"wp-block-paragraph\">Schlie\u00dflich \u00fcberpr\u00fcfte das Team Schulungsmaterialien zu Abweichungs- und CAPA-Prozessen, identifizierte L\u00fccken und empfahl Aktualisierungen oder Verbesserungen.<\/p>\n","protected":false},"author":8,"featured_media":7091,"template":"","client-success-story-category":[311],"class_list":["post-64878","client-success-story","type-client-success-story","status-publish","has-post-thumbnail","hentry","client-success-story-category-pharma-biowissenschaften"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Strategische CAPA-Prozessbewertung in der Pharmaindustrie bringt wichtige Erkenntnisse - Kepner-Tregoe<\/title>\n<meta name=\"description\" content=\"Ein f\u00fchrendes globales Pharmaunternehmen, das sich der weltweiten Verbesserung der Gesundheitsversorgung durch die Bereitstellung innovativer pharmazeutischer Produkte verschrieben hat\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kepner-tregoe.com\/de\/about\/client-success-stories\/strategic-capa-process-assessment\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Strategische CAPA-Prozessbewertung in der Pharmaindustrie bringt wichtige Erkenntnisse\" \/>\n<meta property=\"og:description\" content=\"Ein f\u00fchrendes globales Pharmaunternehmen, das sich der weltweiten Verbesserung der Gesundheitsversorgung durch die Bereitstellung innovativer pharmazeutischer Produkte verschrieben hat\" \/>\n<meta property=\"og:url\" content=\"https:\/\/kepner-tregoe.com\/de\/about\/client-success-stories\/strategic-capa-process-assessment\/\" \/>\n<meta property=\"og:site_name\" content=\"Kepner-Tregoe\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-26T11:26:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/kepner-tregoe.com\/wp-content\/uploads\/2025\/07\/1-4.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1400\" \/>\n\t<meta property=\"og:image:height\" content=\"692\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/kepner-tregoe.com\\\/de\\\/about\\\/client-success-stories\\\/strategic-capa-process-assessment\\\/\",\"url\":\"https:\\\/\\\/kepner-tregoe.com\\\/de\\\/about\\\/client-success-stories\\\/strategic-capa-process-assessment\\\/\",\"name\":\"Strategische CAPA-Prozessbewertung in der Pharmaindustrie bringt wichtige Erkenntnisse - 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