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Artificial Intelligence Algorithm Qualification: A Quality by Design Approach to Apply Artificial Intelligence in

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This summary is machine-generated.

This study introduces a standard procedure for qualifying Artificial Intelligence (AI) algorithms in regulated industries. It ensures AI

Keywords:
4th Industrial RevolutionAlgorithmsArtificial intelligenceDesign of SpacePharma 4.0Pharmaceutical industryQbDQualificationQualityQuality by DesignSmart industry

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Area of Science:

  • Quality Management and Control
  • Artificial Intelligence in Manufacturing
  • Statistical Process Control

Background:

  • Quality is defined by measurable features of products/services satisfying needs.
  • Statistical control offers superior quality outcomes compared to inspection alone.
  • Artificial Intelligence (AI) has potential in quality control but requires algorithm qualification.

Purpose of the Study:

  • To present a standard procedure for qualifying AI algorithms for regulated environments.
  • To ensure AI's reliable application in quality control for products and services.
  • To provide guidance for AI algorithm qualification using Quality by Design (QbD) principles.

Main Methods:

  • Development of a standardized procedure for AI algorithm qualification.
  • Application of Quality by Design (QbD) principles as the foundational framework.
  • Focus on AI's role in ensuring product and service quality in regulated sectors.

Main Results:

  • A defined procedure enabling AI algorithm use in regulated quality control.
  • AI algorithms can be qualified using QbD guidelines for reliable application.
  • Enhanced quality assurance for products and services through qualified AI.

Conclusions:

  • AI algorithms can be effectively qualified for regulated quality control using QbD.
  • This approach ensures the integrity and reliability of AI in quality assurance.
  • Standardized AI qualification is crucial for its successful implementation in industries like pharmaceuticals.