Validation of AI-based Information Systems for Sensitive Use Cases: Using an XAI Approach in Pharmaceutical Engineering

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dc.contributor.authorPolzer, Anna
dc.contributor.authorFleiß, Jürgen
dc.contributor.authorEbner, Thomas
dc.contributor.authorKainz, Philipp
dc.contributor.authorKoeth, Christoph
dc.contributor.authorThalmann, Stefan
dc.date.accessioned2021-12-24T17:30:20Z
dc.date.available2021-12-24T17:30:20Z
dc.date.issued2022-01-04
dc.description.abstractArtificial Intelligence (AI) is adopted in many businesses. However, adoption lacks behind for use cases with regulatory or compliance requirements, as validation and auditing of AI is still unresolved. AI's opaqueness (i.e., "black box") makes the validation challenging for auditors. Explainable AI (XAI) is the proposed technical countermeasure that can support validation and auditing of AI. We developed an XAI based validation approach for AI in sensitive use cases that facilitates the understanding of the system's behaviour. We conducted a case study in pharmaceutical manufacturing where strict regulatory requirements are present. The validation approach and an XAI prototype were developed through multiple workshops and was then tested and evaluated with interviews. Our approach proved suitable to collect the required evidence for a software validation, but requires additional efforts compared to a traditional software validation. AI validation is an iterative process and clear regulations and guidelines are needed.
dc.format.extent10 pages
dc.identifier.doi10.24251/HICSS.2022.186
dc.identifier.isbn978-0-9981331-5-7
dc.identifier.urihttp://hdl.handle.net/10125/79518
dc.language.isoeng
dc.relation.ispartofProceedings of the 55th Hawaii International Conference on System Sciences
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectExplainable Artificial Intelligence (XAI)
dc.subjectartificial intelligence
dc.subjectexplainable artificial intelligence
dc.subjectit auditing
dc.subjectpharmaceutical industry
dc.subjectsoftware validation
dc.titleValidation of AI-based Information Systems for Sensitive Use Cases: Using an XAI Approach in Pharmaceutical Engineering
dc.type.dcmitext

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