Validation & Uncertainty Quantification

Contestability & redress

Data & digital tools: 

If the digital CMC tool(s) uses patient data, and/or AI system decision-making that impacts patients, seek legal support to determine if appropriate processes or mechanisms should be available for questioning and for redress for individuals and groups that are adversely affected by decisions based on algorithms.   (Ref. ISO 24368; WHO Ethics and Governance of AI for Health).

Personnel Training:

Ensure developers understand and implement quality control mechanisms, and, specifically, apply current quality controls standards in the context of model use.​

Links:

ICH Q9(R1): https://database.ich.org/sites/default/files/ICH_Q9%28R1%29_Guideline_Step4_2025_0115_0.pdf

ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf

ICH Q12: https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf

ICH Q14: https://database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1130_ErrorCorrection_2025.pdf

ISO/IEC 5259:2024-2025 (AI data quality management bundle): https://www.iso.org/publication/PUB200525.html

ISO/IEC 23894:2023 (Information technology — Artificial intelligence — Guidance on risk management): https://www.iso.org/standard/77304.html

ISO/IEC TR 24027:2021 (Information technology — Artificial intelligence (AI) — Bias in AI systems and AI aided decision making): https://www.iso.org/standard/77607.html

ISO/IEC 25010:2023 (Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — Product quality model): https://www.iso.org/standard/78176.html

ISO/IEC/IEEE 29119-1:2022 (Software and systems engineering — Software testing Part 1: General concepts): https://www.iso.org/standard/81291.html

ISO 42001:2023 (Information technology — Artificial intelligence — Management system): https://www.iso.org/standard/42001

ISPE GAMP Guide: Artificial Intelligence: https://ispe.org/publications/guidance-documents/gamp-guide-artificial-intelligence?utm_source=HubSpot&utm_medium=Popup&utm_campaign=Guide%20GAMP%20AI&hsCtaAttrib=192776150296

ASME VV40: https://www.asme.org/codes-standards/find-codes-standards/assessing-credibility-of-computational-modeling-through-verification-and-validation-application-to-medical-devices

ASME VVUQ 1: https://www.asme.org/codes-standards/find-codes-standards/verification-validation-and-uncertainty-quantification-terminology-in-computational-modeling-and-simulation/2022/pdf

FDA Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

EMA and FDA set common principles for AI in medicine development: https://www.ema.europa.eu/en/news/ema-fda-set-common-principles-ai-medicine-development-0

UK Government A pro-innovation approach to AI regulation: https://www.gov.uk/government/publications/ai-regulation-a-pro-innovation-approach/white-paper