Month: February 2023

Data Integrity Compliance for Paper Forms and Electronic Data Created in Regulated Laboratories and Manufacturing – Where Forms are Used Today in Regulated GxP Environments

 

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 Boston Area Chapter Board and Education Program Committee (EPC). Continue reading “Data Integrity Compliance for Paper Forms and Electronic Data Created in Regulated Laboratories and Manufacturing – Where Forms are Used Today in Regulated GxP Environments”