Regulation U.S. Food and Drug Administration · October 2, 2024 · National (U.S.)
FDA finalizes guidance on electronic systems, records, and signatures in clinical investigations (external link to U.S. Food and Drug Administration)
FDA issued the final question-and-answer guidance "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations," superseding the 2007 "Computerized Systems Used in Clinical Investigations" guidance. It addresses how Part 11 and related requirements apply to current trial conduct: electronic records and systems used by sponsors and sites, IT service providers and cloud hosting, data from real-world data sources and digital health technologies, audit trail expectations, validation proportionate to risk, and acceptable electronic signature methods.
Why it matters
Part 11 questions consume a disproportionate share of vendor-selection and audit conversations, and this guidance is now the reference point. It gives current, citable answers on cloud-hosted systems, audit trails, and what validation should mean in proportion to risk — useful both for qualifying systems and for resisting compliance theater. Teams whose SOPs still cite the 2007 computerized-systems guidance should update references and revisit the assumptions built on it.
Federal agency final guidance · Topics: 21 CFR Part 11, electronic records, electronic signatures, system validation · Checked September 1, 2026 · Read the original at U.S. Food and Drug Administration (external link)