Building Regulatory Confidence with Human-in-the-Loop AI in Paperless GMP Validation
Manaliben Amin*
Journal on Artificial Intelligence, Vol.8, pp. 1-18, 2026, DOI:10.32604/jai.2026.073895
- 07 January 2026
（This article belongs to the Special Issue: Advances in Artificial Intelligence for Engineering and Sciences)
Abstract Artificial intelligence (AI) is steadily making its way into pharmaceutical validation, where it promises faster documentation, smarter testing strategies, and better handling of deviations. These gains are attractive, but in a regulated environment speed is never enough. Regulators want assurance that every system is reliable, that decisions are explainable, and that human accountability remains central. This paper sets out a Human-in-the-Loop (HITL) AI approach for Computer System Validation (CSV) and Computer Software Assurance (CSA). It relies on explainable AI (XAI) tools but keeps structured human review in place, so automation can be used without creating… More >
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