The Regulatory Affairs AI Playbook: How RA Professionals Run FDA, EMA & PMDA Submissions with GMLP-Compliant AI and 21 CFR Part 11 Validation

Your team uses AI to draft Module 2 summaries. Your QA group asked for the validation file. You realized it doesn't exist yet. This book is the answer. Regulatory Affairs in pharma and medtech sits at the intersection of two unforgiving systems: regulators that audit everything, and AI tools that generate everything. GMLP, computer system validation (21 CFR Part 11, EU Annex 11), and the new FDA guidance on AI in regulated workflows have to be operationalized — not just acknowledged. This Playbook is for the RA professional who needs validated AI use without slowing the submission timeline. Inside: CSV (computer system validation) templates for AI tools — IQ/OQ/PQ (full templates); change control and periodic review (procedures) eCTD section drafting workflows with AI assistance and audit trails GMLP-compliant deployment patterns Submission section templates: Module 2 summaries, label change tracking, predicate device comparisons Audit trail requirements: what to log, how long to retain, in what format EMA and PMDA-specific considerations Inspection readiness for AI-touched submissions Written for: RAPS-certified Regulatory Affairs professionals, CMC writers, submission managers, QA leaders in pharma and medtech, and FDA inspection response leads preparing for AI-touched submission audits.