Guest Author: Heather Longden Ms. Heather Longden has thirty (30) years of experience in regulatory compliance in the pharmaceutical industry and is an expert in data integrity, data management, 21 CFR Part 11, GxPs, and computer system validation. She is a leader at the GAMP® Americas Steering Committee and serves on the the ISPE … Continue reading "Data Integrity Compliance for Paper Forms and Electronic Data Created in Regulated Laboratories and Manufacturing – A Review of Two Recent FDA Warning Letters"
