Validation & Uncertainty Quantification
Accountability & governance
Data & digital tools:
Compliance with SOPs and applicable GLP/GMP expectations; deployment defined. Need for Quality System revisions evaluated for implementation of digital CMC tool(s). Cybersecurity risks considered.
Personnel Training:
Training for regulatory affairs and quality teams.
Links:
ICH Q7: https://database.ich.org/sites/default/files/Q7%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 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 42001:2023 (Information technology — Artificial intelligence — Management system): https://www.iso.org/standard/42001
ISPE GAMP Guide: Artificial Intelligence, Available at https://ispe.org/publications/guidance-documents/gamp-guide-artificial-intelligence?utm_source=HubSpot&utm_medium=Popup&utm_campaign=Guide%20GAMP%20AI&hsCtaAttrib=192776150296
OECD Good Laboratory Practice and Compliance Monitoring: https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/good-laboratory-practice-and-compliance-monitoring.html
FDA Responsive Regulation of Artificial Intelligence in Drug Development: https://www.fda.gov/media/184256/download
FDA Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological
FDA Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products: https://www.fda.gov/media/167973/download
NIST Secure Software Development Framework SSDF: https://csrc.nist.gov/Projects/ssdf
NIST Artificial Intelligence Risk Management Framework (AI RMF 1.0): https://www.nist.gov/publications/artificial-intelligence-risk-management-framework-ai-rmf-10
NIST Artificial Intelligence Risk Management Framework: Generative Artificial Intelligence Profile: https://www.nist.gov/publications/artificial-intelligence-risk-management-framework-generative-artificial-intelligence
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
EMA Data Quality Framework for EU Medicines Regulation: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf
EU GMP Annex 15; European Commission: https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en
UK Government Guidance on GxP data integrity: https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity
UK Government DSIT A pro-innovation approach to AI regulation: https://assets.publishing.service.gov.uk/media/65c1e399c43191000d1a45f4/a-pro-innovation-approach-to-ai-regulation-amended-governement-response-web-ready.pdf
UK Government Artificial Intelligence Playbook for the UK Government: https://www.gov.uk/government/publications/ai-playbook-for-the-uk-government/artificial-intelligence-playbook-for-the-uk-government-html
MHRA ‘GXP’ Data Integrity Guidance and Definitions, Available at https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf