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IEEE/ICACT20260305 Question.4
Questioner: gonghao23@mails.ucas.ac.cn    2026-02-23 ¿ÀÈÄ 11:26:13
IEEE/ICACT20260305 Answer.4
Answer by Auhor iyaqoob@csu.edu.au   2026-02-23 ¿ÀÈÄ 11:26:13
The authors acknowledge a significant regulatory gap — no dedicated guidelines currently exist for digital twin-driven audits under frameworks like 21 CFR Part 11 or GAMP. Given this vacuum, what governance mechanisms or interim validation protocols should organizations adopt to ensure metaverse-based audit evidence is legally defensible and accepted by agencies such as the FDA or EMA?

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