Articles tagged with “pharmaceutical-validation”

FDA PreCheck Type V DMF: A Digital-Thread Blueprint

A 2026 implementation blueprint for FDA PreCheck Type V DMFs, mapping four POR elements to facility data ownership, traceability, change control, and a 90-day launch plan.

28 min read

9/19/2026

fda precheck type v dmf fda precheck program type v drug master file pre-operational review pharmaceutical facility readiness digital thread pharmaceutical validation facility quality information regulatory operations

Validating Generative AI in GxP: A 21 CFR Part 11 Framework

Updated 2026 framework for validating generative AI in GxP systems. Covers 21 CFR Part 11, EU Annex 22, ISPE GAMP AI Guide, FDA CSA guidance, and FDA-EMA joint AI principles

40 min read

10/28/2025

generative ai 21 cfr part 11 gxp computer software assurance data integrity pharmaceutical validation alcoa+life sciences fda compliance eu annex 11 ai