Spreadsheets, lab data, paper records, and AI: what the regulation requires, where organizations fail, and how to fix it.
| WHY THIS MATTERS NOW |
| FY2024 saw the highest FDA warning letter volume in five years, with data integrity as the leading citation category. Three forces are compounding the challenge: stricter FDA enforcement, digital transformation creating new compliance surfaces, and AI adoption creating obligations that most Part 11 programs were never designed for. |
