Development & Verification

Safety, security & robustness

Data & digital tools: 

Data collated, curated, and metadata tagged; implementation testing to confirm algorithm correctness. Bias risks assessed in data collection and sharing; automated data capture implemented where appropriate.; Ensure data distribution is fit for purpose for QoI and reproducible.; Ensure results applicability for QoI.; Standardise continuous deployment protocols.; Ensure traceability. Data integrity assured (WHO TRS 1033 Annex 4; ISO 5259).​

Personnel Training:

Use of sandbox or safe environments for testing and learning.​

Links:

ICH Q2(R2): https://database.ich.org/sites/default/files/ICH_Q2%28R2%29_Guideline_2023_1130_ErrorCorrection_2025.pdf

ICH Q8(R2): https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf

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 Q13: https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.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 5338:2023 (AI system life cycle processes): https://www.iso.org/obp/ui/en/#iso:std:iso-iec:5338:ed-1:v1:en

ISO/IEC 5469 :2024 (Functional safety and AI systems): https://www.iso.org/standard/81283.htmlISO/IEC TR 24028:2020 (Information technology — Artificial intelligence — Overview of trustworthiness in artificial intelligence): https://www.iso.org/standard/77608.html

ISO/IEC CD TS 8200:2024 (Information technology — Artificial intelligence — Controllability of automated artificial intelligence systems): https://www.iso.org/standard/83012.html

ISO/IEC 22989:2022 (Information technology — Artificial intelligence — Artificial intelligence concepts and terminology): https://www.iso.org/standard/74296.html

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

ISO/IEC TR 24028:2020 (Information technology — Artificial intelligence — Overview of trustworthiness in artificial intelligence): https://www.iso.org/standard/77608.html

ISO/IEC TR 24029-1:2021 (Artificial Intelligence (AI) — Assessment of the robustness of neural networks Part 1: Overview): https://www.iso.org/standard/77609.html

ISO/IEC TR 29119-11:2020 (Software and systems engineering — Software testing Part 11: Guidelines on the testing of AI-based systems): https://www.iso.org/standard/79016.html

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

ISPE AI GAMP: Artificial Intelligence GUIDE: https://ispe.org/publications/guidance-documents/gamp-guide-artificial-intelligence

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

FDA Artificial Intelligence in Drug Manufacturing: https://www.fda.gov/media/165743/download?attachment

FDA Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products: https://www.fda.gov/media/167973/download

FDA Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions

FDA Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry: https://www.fda.gov/media/119267/download

FDA Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological

FDA Guidance on GxP data integrity: https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity

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

EMA Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle: https://www.ema.europa.eu/system/files/documents/scientific-guideline/reflection-paper-use-artificial-intelligence-ai-medicinal-product-lifecycle-en.pdf

MHRA Impact of AI on the regulation of medical products: https://assets.publishing.service.gov.uk/media/662fce1e9e82181baa98a988/MHRA_Impact-of-AI-on-the-regulation-of-medical-products.pdf

UK Gov Software and artificial intelligence (AI) as a medical device: https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device/software-and-artificial-intelligence-ai-as-a-medical-device