Development & Verification
Accountability
Data & digital tools:
Audit trails implemented to record decisions, data, and contributors. Evaluate if enhancements to governance systems are needed to assure data quality, for example through consideration of ISO 5259-5.
Personnel Training:
Ensure awareness of regulatory expectations for developers.
Links:
ICH Q7: https://database.ich.org/sites/default/files/Q7%20Guideline.pdf
ICH Q13: https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.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: https://ispe.org/publications/guidance-documents/gamp-guide-artificial-intelligence?utm_source=HubSpot&utm_medium=Popup&utm_campaign=Guide%20GAMP%20AI&hsCtaAttrib=192776150296
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
ALCOA Data-Integrity Principles: A Complete 2025 Guide, Available at https://redica.com/data-integrity-and-alcoa/
Society for Clinical Data Management: Audit Trail Review: A key Tool to Ensure Data Integrity: https://www.scdm.org/wp-content/uploads/2024/07/2021-eCF_SCDM-ATR-Industry-Position-Paper-Version-PR1-2.pdf
MHRA ‘GXP’ Data Integrity Guidance and Definitions, Available at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/687246/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf