Symfony Profiler

"AppBundle\Controller\DefaultController::defaultAction"

false

AppBundle\Controller\DefaultController {#2141
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  #logger: Pimcore\Bundle\ApplicationLoggerBundle\ApplicationLogger {#2142 …}
}

Symfony\Component\WebLink\GenericLinkProvider {#5309
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    5310 => Symfony\Component\WebLink\Link {#5310
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"de_DE"

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true

"document_218"

[
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Pimcore\Model\Site {#1975
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"/inconsult.de/news/blog/ki-unterstützte-validierung-von-computersystemen"

"e09d4b"

Pimcore\Model\Document\Page {#2214
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    }
    "content:1.text-opening-body" => Pimcore\Model\Document\Editable\Wysiwyg {#3567
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        <p><strong>26. April 2023</strong></p>\n
        \n
        <p>Künstliche Intelligenz ist zu einem festen Bestandteil unseres Alltags geworden. Es ist daher nicht verwunderlich, dass KI auch in der Medizintechnik und der Arzneimittelherstellung eine wachsende Rolle spielt. Unternehmen aus stark regulierten Branchen wie Pharmaunternehmen und Medizinproduktehersteller stehen in diesem Zusammenhang jedoch vor besonderen Herausforderungen, da computergestützte Systeme in einem solchen Umfeld transparent, nachvollziehbar und reproduzierbar arbeiten müssen (GxP). Die Überprüfung einer solchen Anforderung erfolgt durch den Prozess der Validierung. Die Validierung liefert den dokumentierten Nachweis, dass ein Prozess oder ein System die spezifizierten Anforderungen unter Feldbedingungen reproduzierbar erfüllt. KI-basierte Systeme sind derzeit nicht in der Lage, diese Anforderungen ohne weiteres zu erfüllen, und die gesetzlichen Anforderungen an die Validierung von KI/ML-basierten Systemen stecken noch in den Kinderschuhen.&nbsp;</p>\n
        \n
        <p>Doch nicht nur die Validierung von KI-gestützten Systemen, sondern auch die KI-gestützte Validierung verspricht ungenutztes Potenzial. In der aktuellen Arbeit von Validierern spielen KI-basierte Werkzeuge eine untergeordnete Rolle. Das Spezifizieren von Anforderungen, das Schreiben von Szenarien und das Festlegen von User Stories ist ein zeitaufwändiger Prozess und erfordert die Entwicklung, Kontrolle und Pflege umfangreicher Dokumente und/oder langer, sperriger Listen. Gleichzeitig stellt die Arbeit mit Systemanforderungen auch viele Anforderungen an den Sprachgebrauch. Zum Beispiel dürfen Anforderungen nicht mehrdeutig sein, sollten Rollen und Akteure beinhalten und müssen messbar sein (SMART). Mit den aktuellen Fortschritten in der Verarbeitung natürlicher Sprache (Natural Language Processing, NLP), einer Teilmenge von KI/ML, ist es möglich, die Arbeit der Validierer erheblich zu erleichtern und die Qualität der Spezifikationen wesentlich zu steigern. Über Thesauri und Ontologien hinaus sind NLP-Techniken in der Lage, Sprache zu verstehen und Anforderungsbeschreibungen auf problematischen Sprachgebrauch und Mehrdeutigkeiten zu untersuchen. Dies trägt dazu bei, optimale Ergebnisse im Requirements-Engineering-Prozess und bei der Erstellung von User Requirements Specifications (URS) zu gewährleisten und die Anforderungen SMART und redundanzfrei zu halten.</p>\n
        \n
        <p>Inconsult hat eine Reihe von KI/ML-Methoden zur Verbesserung der Validierung, insbesondere im medizinisch-pharmazeutischen Umfeld, entwickelt, um die Spezifikation von Anforderungen automatisch auf Kompatibilität mit den SMART-Kriterien zu prüfen sowie redundanzfrei zu halten. Die Verbesserung der Qualität in den Planungsprozessen für die Einführung und Änderung von computergestützten Systemen zahlt sich insbesondere deshalb aus, weil auf diese Weise Probleme, die sich normalerweise erst in der Implementierungsphase zeigen würden, von vornherein vermieden werden können. Auch die von Inconsult entwickelten Werkzeuge zum Datenaustausch über URS/FS erleichtern die Arbeit des Requirements Engineering insbesondere auf Kundenseite erheblich, da die Zusammenarbeit über Datenformate gängiger Tabellenkalkulationsprogramme vermieden wird. Darüber hinaus erleichtert das Tool die Nachvollziehbarkeit von Anforderungen.</p>\n
        \n
        <p>Wenn Sie mehr über unseren KI-gestützten Validierungsansatz erfahren möchten, stehen Ihnen unsere Experten <a href="https://www.linkedin.com/in/tilljostes/">Till Jostes</a> (Head of Validation) und <a href="https://www.linkedin.com/in/dr-matthias-ruediger/">Dr. Matthias Rüdiger</a> (Head of AI) gerne zur Verfügung und beantworten Ihre Fragen.</p>\n
        """
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        <p><strong>26. April 2023</strong></p>\n
        \n
        <p>Künstliche Intelligenz ist zu einem festen Bestandteil unseres Alltags geworden. Es ist daher nicht verwunderlich, dass KI auch in der Medizintechnik und der Arzneimittelherstellung eine wachsende Rolle spielt. Unternehmen aus stark regulierten Branchen wie Pharmaunternehmen und Medizinproduktehersteller stehen in diesem Zusammenhang jedoch vor besonderen Herausforderungen, da computergestützte Systeme in einem solchen Umfeld transparent, nachvollziehbar und reproduzierbar arbeiten müssen (GxP). Die Überprüfung einer solchen Anforderung erfolgt durch den Prozess der Validierung. Die Validierung liefert den dokumentierten Nachweis, dass ein Prozess oder ein System die spezifizierten Anforderungen unter Feldbedingungen reproduzierbar erfüllt. KI-basierte Systeme sind derzeit nicht in der Lage, diese Anforderungen ohne weiteres zu erfüllen, und die gesetzlichen Anforderungen an die Validierung von KI/ML-basierten Systemen stecken noch in den Kinderschuhen.&nbsp;</p>\n
        \n
        <p>Doch nicht nur die Validierung von KI-gestützten Systemen, sondern auch die KI-gestützte Validierung verspricht ungenutztes Potenzial. In der aktuellen Arbeit von Validierern spielen KI-basierte Werkzeuge eine untergeordnete Rolle. Das Spezifizieren von Anforderungen, das Schreiben von Szenarien und das Festlegen von User Stories ist ein zeitaufwändiger Prozess und erfordert die Entwicklung, Kontrolle und Pflege umfangreicher Dokumente und/oder langer, sperriger Listen. Gleichzeitig stellt die Arbeit mit Systemanforderungen auch viele Anforderungen an den Sprachgebrauch. Zum Beispiel dürfen Anforderungen nicht mehrdeutig sein, sollten Rollen und Akteure beinhalten und müssen messbar sein (SMART). Mit den aktuellen Fortschritten in der Verarbeitung natürlicher Sprache (Natural Language Processing, NLP), einer Teilmenge von KI/ML, ist es möglich, die Arbeit der Validierer erheblich zu erleichtern und die Qualität der Spezifikationen wesentlich zu steigern. Über Thesauri und Ontologien hinaus sind NLP-Techniken in der Lage, Sprache zu verstehen und Anforderungsbeschreibungen auf problematischen Sprachgebrauch und Mehrdeutigkeiten zu untersuchen. Dies trägt dazu bei, optimale Ergebnisse im Requirements-Engineering-Prozess und bei der Erstellung von User Requirements Specifications (URS) zu gewährleisten und die Anforderungen SMART und redundanzfrei zu halten.</p>\n
        \n
        <p>Inconsult hat eine Reihe von KI/ML-Methoden zur Verbesserung der Validierung, insbesondere im medizinisch-pharmazeutischen Umfeld, entwickelt, um die Spezifikation von Anforderungen automatisch auf Kompatibilität mit den SMART-Kriterien zu prüfen sowie redundanzfrei zu halten. Die Verbesserung der Qualität in den Planungsprozessen für die Einführung und Änderung von computergestützten Systemen zahlt sich insbesondere deshalb aus, weil auf diese Weise Probleme, die sich normalerweise erst in der Implementierungsphase zeigen würden, von vornherein vermieden werden können. Auch die von Inconsult entwickelten Werkzeuge zum Datenaustausch über URS/FS erleichtern die Arbeit des Requirements Engineering insbesondere auf Kundenseite erheblich, da die Zusammenarbeit über Datenformate gängiger Tabellenkalkulationsprogramme vermieden wird. Darüber hinaus erleichtert das Tool die Nachvollziehbarkeit von Anforderungen.</p>\n
        \n
        <p>Wenn Sie mehr über unseren KI-gestützten Validierungsansatz erfahren möchten, stehen Ihnen unsere Experten <a href="https://www.linkedin.com/in/tilljostes/">Till Jostes</a> (Head of Validation) und <a href="https://www.linkedin.com/in/dr-matthias-ruediger/">Dr. Matthias Rüdiger</a> (Head of AI) gerne zur Verfügung und beantworten Ihre Fragen.</p>\n
        """
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    "headline-level" => Pimcore\Model\Document\Editable\Select {#3564
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      #config: [
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      document: Pimcore\Model\Document\Page {#2214}
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  #scheduledTasks: null
  #title: "INCONSULT - KI-unterstützte Validierung von Computersystemen"
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Pimcore\Routing\DocumentRoute {#2218
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          <p><strong>26. April 2023</strong></p>\n
          \n
          <p>Künstliche Intelligenz ist zu einem festen Bestandteil unseres Alltags geworden. Es ist daher nicht verwunderlich, dass KI auch in der Medizintechnik und der Arzneimittelherstellung eine wachsende Rolle spielt. Unternehmen aus stark regulierten Branchen wie Pharmaunternehmen und Medizinproduktehersteller stehen in diesem Zusammenhang jedoch vor besonderen Herausforderungen, da computergestützte Systeme in einem solchen Umfeld transparent, nachvollziehbar und reproduzierbar arbeiten müssen (GxP). Die Überprüfung einer solchen Anforderung erfolgt durch den Prozess der Validierung. Die Validierung liefert den dokumentierten Nachweis, dass ein Prozess oder ein System die spezifizierten Anforderungen unter Feldbedingungen reproduzierbar erfüllt. KI-basierte Systeme sind derzeit nicht in der Lage, diese Anforderungen ohne weiteres zu erfüllen, und die gesetzlichen Anforderungen an die Validierung von KI/ML-basierten Systemen stecken noch in den Kinderschuhen.&nbsp;</p>\n
          \n
          <p>Doch nicht nur die Validierung von KI-gestützten Systemen, sondern auch die KI-gestützte Validierung verspricht ungenutztes Potenzial. In der aktuellen Arbeit von Validierern spielen KI-basierte Werkzeuge eine untergeordnete Rolle. Das Spezifizieren von Anforderungen, das Schreiben von Szenarien und das Festlegen von User Stories ist ein zeitaufwändiger Prozess und erfordert die Entwicklung, Kontrolle und Pflege umfangreicher Dokumente und/oder langer, sperriger Listen. Gleichzeitig stellt die Arbeit mit Systemanforderungen auch viele Anforderungen an den Sprachgebrauch. Zum Beispiel dürfen Anforderungen nicht mehrdeutig sein, sollten Rollen und Akteure beinhalten und müssen messbar sein (SMART). Mit den aktuellen Fortschritten in der Verarbeitung natürlicher Sprache (Natural Language Processing, NLP), einer Teilmenge von KI/ML, ist es möglich, die Arbeit der Validierer erheblich zu erleichtern und die Qualität der Spezifikationen wesentlich zu steigern. Über Thesauri und Ontologien hinaus sind NLP-Techniken in der Lage, Sprache zu verstehen und Anforderungsbeschreibungen auf problematischen Sprachgebrauch und Mehrdeutigkeiten zu untersuchen. Dies trägt dazu bei, optimale Ergebnisse im Requirements-Engineering-Prozess und bei der Erstellung von User Requirements Specifications (URS) zu gewährleisten und die Anforderungen SMART und redundanzfrei zu halten.</p>\n
          \n
          <p>Inconsult hat eine Reihe von KI/ML-Methoden zur Verbesserung der Validierung, insbesondere im medizinisch-pharmazeutischen Umfeld, entwickelt, um die Spezifikation von Anforderungen automatisch auf Kompatibilität mit den SMART-Kriterien zu prüfen sowie redundanzfrei zu halten. Die Verbesserung der Qualität in den Planungsprozessen für die Einführung und Änderung von computergestützten Systemen zahlt sich insbesondere deshalb aus, weil auf diese Weise Probleme, die sich normalerweise erst in der Implementierungsphase zeigen würden, von vornherein vermieden werden können. Auch die von Inconsult entwickelten Werkzeuge zum Datenaustausch über URS/FS erleichtern die Arbeit des Requirements Engineering insbesondere auf Kundenseite erheblich, da die Zusammenarbeit über Datenformate gängiger Tabellenkalkulationsprogramme vermieden wird. Darüber hinaus erleichtert das Tool die Nachvollziehbarkeit von Anforderungen.</p>\n
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          <p><strong>26. April 2023</strong></p>\n
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          <p>Künstliche Intelligenz ist zu einem festen Bestandteil unseres Alltags geworden. Es ist daher nicht verwunderlich, dass KI auch in der Medizintechnik und der Arzneimittelherstellung eine wachsende Rolle spielt. Unternehmen aus stark regulierten Branchen wie Pharmaunternehmen und Medizinproduktehersteller stehen in diesem Zusammenhang jedoch vor besonderen Herausforderungen, da computergestützte Systeme in einem solchen Umfeld transparent, nachvollziehbar und reproduzierbar arbeiten müssen (GxP). Die Überprüfung einer solchen Anforderung erfolgt durch den Prozess der Validierung. Die Validierung liefert den dokumentierten Nachweis, dass ein Prozess oder ein System die spezifizierten Anforderungen unter Feldbedingungen reproduzierbar erfüllt. KI-basierte Systeme sind derzeit nicht in der Lage, diese Anforderungen ohne weiteres zu erfüllen, und die gesetzlichen Anforderungen an die Validierung von KI/ML-basierten Systemen stecken noch in den Kinderschuhen.&nbsp;</p>\n
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          \n
          <p>Inconsult hat eine Reihe von KI/ML-Methoden zur Verbesserung der Validierung, insbesondere im medizinisch-pharmazeutischen Umfeld, entwickelt, um die Spezifikation von Anforderungen automatisch auf Kompatibilität mit den SMART-Kriterien zu prüfen sowie redundanzfrei zu halten. Die Verbesserung der Qualität in den Planungsprozessen für die Einführung und Änderung von computergestützten Systemen zahlt sich insbesondere deshalb aus, weil auf diese Weise Probleme, die sich normalerweise erst in der Implementierungsphase zeigen würden, von vornherein vermieden werden können. Auch die von Inconsult entwickelten Werkzeuge zum Datenaustausch über URS/FS erleichtern die Arbeit des Requirements Engineering insbesondere auf Kundenseite erheblich, da die Zusammenarbeit über Datenformate gängiger Tabellenkalkulationsprogramme vermieden wird. Darüber hinaus erleichtert das Tool die Nachvollziehbarkeit von Anforderungen.</p>\n
          \n
          <p>Wenn Sie mehr über unseren KI-gestützten Validierungsansatz erfahren möchten, stehen Ihnen unsere Experten <a href="https://www.linkedin.com/in/tilljostes/">Till Jostes</a> (Head of Validation) und <a href="https://www.linkedin.com/in/dr-matthias-ruediger/">Dr. Matthias Rüdiger</a> (Head of AI) gerne zur Verfügung und beantworten Ihre Fragen.</p>\n
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        <p><strong>26. April 2023</strong></p>\n
        \n
        <p>Künstliche Intelligenz ist zu einem festen Bestandteil unseres Alltags geworden. Es ist daher nicht verwunderlich, dass KI auch in der Medizintechnik und der Arzneimittelherstellung eine wachsende Rolle spielt. Unternehmen aus stark regulierten Branchen wie Pharmaunternehmen und Medizinproduktehersteller stehen in diesem Zusammenhang jedoch vor besonderen Herausforderungen, da computergestützte Systeme in einem solchen Umfeld transparent, nachvollziehbar und reproduzierbar arbeiten müssen (GxP). Die Überprüfung einer solchen Anforderung erfolgt durch den Prozess der Validierung. Die Validierung liefert den dokumentierten Nachweis, dass ein Prozess oder ein System die spezifizierten Anforderungen unter Feldbedingungen reproduzierbar erfüllt. KI-basierte Systeme sind derzeit nicht in der Lage, diese Anforderungen ohne weiteres zu erfüllen, und die gesetzlichen Anforderungen an die Validierung von KI/ML-basierten Systemen stecken noch in den Kinderschuhen.&nbsp;</p>\n
        \n
        <p>Doch nicht nur die Validierung von KI-gestützten Systemen, sondern auch die KI-gestützte Validierung verspricht ungenutztes Potenzial. In der aktuellen Arbeit von Validierern spielen KI-basierte Werkzeuge eine untergeordnete Rolle. Das Spezifizieren von Anforderungen, das Schreiben von Szenarien und das Festlegen von User Stories ist ein zeitaufwändiger Prozess und erfordert die Entwicklung, Kontrolle und Pflege umfangreicher Dokumente und/oder langer, sperriger Listen. Gleichzeitig stellt die Arbeit mit Systemanforderungen auch viele Anforderungen an den Sprachgebrauch. Zum Beispiel dürfen Anforderungen nicht mehrdeutig sein, sollten Rollen und Akteure beinhalten und müssen messbar sein (SMART). Mit den aktuellen Fortschritten in der Verarbeitung natürlicher Sprache (Natural Language Processing, NLP), einer Teilmenge von KI/ML, ist es möglich, die Arbeit der Validierer erheblich zu erleichtern und die Qualität der Spezifikationen wesentlich zu steigern. Über Thesauri und Ontologien hinaus sind NLP-Techniken in der Lage, Sprache zu verstehen und Anforderungsbeschreibungen auf problematischen Sprachgebrauch und Mehrdeutigkeiten zu untersuchen. Dies trägt dazu bei, optimale Ergebnisse im Requirements-Engineering-Prozess und bei der Erstellung von User Requirements Specifications (URS) zu gewährleisten und die Anforderungen SMART und redundanzfrei zu halten.</p>\n
        \n
        <p>Inconsult hat eine Reihe von KI/ML-Methoden zur Verbesserung der Validierung, insbesondere im medizinisch-pharmazeutischen Umfeld, entwickelt, um die Spezifikation von Anforderungen automatisch auf Kompatibilität mit den SMART-Kriterien zu prüfen sowie redundanzfrei zu halten. Die Verbesserung der Qualität in den Planungsprozessen für die Einführung und Änderung von computergestützten Systemen zahlt sich insbesondere deshalb aus, weil auf diese Weise Probleme, die sich normalerweise erst in der Implementierungsphase zeigen würden, von vornherein vermieden werden können. Auch die von Inconsult entwickelten Werkzeuge zum Datenaustausch über URS/FS erleichtern die Arbeit des Requirements Engineering insbesondere auf Kundenseite erheblich, da die Zusammenarbeit über Datenformate gängiger Tabellenkalkulationsprogramme vermieden wird. Darüber hinaus erleichtert das Tool die Nachvollziehbarkeit von Anforderungen.</p>\n
        \n
        <p>Wenn Sie mehr über unseren KI-gestützten Validierungsansatz erfahren möchten, stehen Ihnen unsere Experten <a href="https://www.linkedin.com/in/tilljostes/">Till Jostes</a> (Head of Validation) und <a href="https://www.linkedin.com/in/dr-matthias-ruediger/">Dr. Matthias Rüdiger</a> (Head of AI) gerne zur Verfügung und beantworten Ihre Fragen.</p>\n
        """
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        <p><strong>26. April 2023</strong></p>\n
        \n
        <p>Künstliche Intelligenz ist zu einem festen Bestandteil unseres Alltags geworden. Es ist daher nicht verwunderlich, dass KI auch in der Medizintechnik und der Arzneimittelherstellung eine wachsende Rolle spielt. Unternehmen aus stark regulierten Branchen wie Pharmaunternehmen und Medizinproduktehersteller stehen in diesem Zusammenhang jedoch vor besonderen Herausforderungen, da computergestützte Systeme in einem solchen Umfeld transparent, nachvollziehbar und reproduzierbar arbeiten müssen (GxP). Die Überprüfung einer solchen Anforderung erfolgt durch den Prozess der Validierung. Die Validierung liefert den dokumentierten Nachweis, dass ein Prozess oder ein System die spezifizierten Anforderungen unter Feldbedingungen reproduzierbar erfüllt. KI-basierte Systeme sind derzeit nicht in der Lage, diese Anforderungen ohne weiteres zu erfüllen, und die gesetzlichen Anforderungen an die Validierung von KI/ML-basierten Systemen stecken noch in den Kinderschuhen.&nbsp;</p>\n
        \n
        <p>Doch nicht nur die Validierung von KI-gestützten Systemen, sondern auch die KI-gestützte Validierung verspricht ungenutztes Potenzial. In der aktuellen Arbeit von Validierern spielen KI-basierte Werkzeuge eine untergeordnete Rolle. Das Spezifizieren von Anforderungen, das Schreiben von Szenarien und das Festlegen von User Stories ist ein zeitaufwändiger Prozess und erfordert die Entwicklung, Kontrolle und Pflege umfangreicher Dokumente und/oder langer, sperriger Listen. Gleichzeitig stellt die Arbeit mit Systemanforderungen auch viele Anforderungen an den Sprachgebrauch. Zum Beispiel dürfen Anforderungen nicht mehrdeutig sein, sollten Rollen und Akteure beinhalten und müssen messbar sein (SMART). Mit den aktuellen Fortschritten in der Verarbeitung natürlicher Sprache (Natural Language Processing, NLP), einer Teilmenge von KI/ML, ist es möglich, die Arbeit der Validierer erheblich zu erleichtern und die Qualität der Spezifikationen wesentlich zu steigern. Über Thesauri und Ontologien hinaus sind NLP-Techniken in der Lage, Sprache zu verstehen und Anforderungsbeschreibungen auf problematischen Sprachgebrauch und Mehrdeutigkeiten zu untersuchen. Dies trägt dazu bei, optimale Ergebnisse im Requirements-Engineering-Prozess und bei der Erstellung von User Requirements Specifications (URS) zu gewährleisten und die Anforderungen SMART und redundanzfrei zu halten.</p>\n
        \n
        <p>Inconsult hat eine Reihe von KI/ML-Methoden zur Verbesserung der Validierung, insbesondere im medizinisch-pharmazeutischen Umfeld, entwickelt, um die Spezifikation von Anforderungen automatisch auf Kompatibilität mit den SMART-Kriterien zu prüfen sowie redundanzfrei zu halten. Die Verbesserung der Qualität in den Planungsprozessen für die Einführung und Änderung von computergestützten Systemen zahlt sich insbesondere deshalb aus, weil auf diese Weise Probleme, die sich normalerweise erst in der Implementierungsphase zeigen würden, von vornherein vermieden werden können. Auch die von Inconsult entwickelten Werkzeuge zum Datenaustausch über URS/FS erleichtern die Arbeit des Requirements Engineering insbesondere auf Kundenseite erheblich, da die Zusammenarbeit über Datenformate gängiger Tabellenkalkulationsprogramme vermieden wird. Darüber hinaus erleichtert das Tool die Nachvollziehbarkeit von Anforderungen.</p>\n
        \n
        <p>Wenn Sie mehr über unseren KI-gestützten Validierungsansatz erfahren möchten, stehen Ihnen unsere Experten <a href="https://www.linkedin.com/in/tilljostes/">Till Jostes</a> (Head of Validation) und <a href="https://www.linkedin.com/in/dr-matthias-ruediger/">Dr. Matthias Rüdiger</a> (Head of AI) gerne zur Verfügung und beantworten Ihre Fragen.</p>\n
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  title: "INCONSULT - KI-unterstützte Validierung von Computersystemen"
  description: "Computer funktionieren nicht immer so, wie sie sollten. Um sicherzugehen, dass das Problem nur vor dem Computer sitzt, müssen IT-Systeme in der Pharmaindustrie einen Prozess namens Validierung durchlaufen. Künstliche Intelligenz ist in der Lage, die Validierung computergestützter Systeme (CSV) wesentlich effizienter zu gestalten."
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