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

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dc.contributor.author Polzer, Anna
dc.contributor.author Fleiß, Jürgen
dc.contributor.author Ebner, Thomas
dc.contributor.author Kainz, Philipp
dc.contributor.author Koeth, Christoph
dc.contributor.author Thalmann, Stefan
dc.date.accessioned 2021-12-24T17:30:20Z
dc.date.available 2021-12-24T17:30:20Z
dc.date.issued 2022-01-04
dc.description.abstract Artificial 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.extent 10 pages
dc.identifier.doi 10.24251/HICSS.2022.186
dc.identifier.isbn 978-0-9981331-5-7
dc.identifier.uri http://hdl.handle.net/10125/79518
dc.language.iso eng
dc.relation.ispartof Proceedings of the 55th Hawaii International Conference on System Sciences
dc.rights Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subject Explainable Artificial Intelligence (XAI)
dc.subject artificial intelligence
dc.subject explainable artificial intelligence
dc.subject it auditing
dc.subject pharmaceutical industry
dc.subject software validation
dc.title Validation of AI-based Information Systems for Sensitive Use Cases: Using an XAI Approach in Pharmaceutical Engineering
dc.type.dcmi text
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