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- W4307979504 abstract "Abstract Purpose The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in-vitro diagnostics (IVD), poses new regulatory problems: a lack of a common terminology and understanding leads to confusion, delays and product failures. Validation as a key step in product development, common to each of these sectors including computerized systems and AI/ML development, offers an opportune point of comparison for aligning people and processes for cross-sectoral product development. Methods A comparative approach, built upon workshops and a subsequent written sequence of exchanges, summarized in a look-up table suitable for mixed-teams work. Results 1. A bottom-up, definitions led, approach which leads to a distinction between broad vs narrow validation, and their relationship to regulatory regimes. 2. Common basis introduction to the primary methodologies for AI-containing software validation. 3. Pharmaceutical drug development and MD/IVD specific perspectives on compliant AI software development, as a basis for collaboration. Conclusions Alignment of the terms and methodologies used in validation of software products containing artificial intelligence / machine learning (AI/ML) components across the regulated industries of human health is a vital first step in streamlining processes and improving workflows." @default.
- W4307979504 created "2022-11-07" @default.
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- W4307979504 date "2022-11-02" @default.
- W4307979504 modified "2023-10-18" @default.
- W4307979504 title "Validation of artificial intelligence containing products across the regulated healthcare industries" @default.
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- W4307979504 doi "https://doi.org/10.21203/rs.3.rs-2153749/v1" @default.
- W4307979504 hasPublicationYear "2022" @default.
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