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).
In this moths blog, I will dive deeper into why and where paper/printed forms are still used in Pharma manufacturing and testing facilities who are purporting to meet regulatory GxP requirements.
But first, a couple of definitions and notes. In most cases, I will be referring to forms that are printed, completed in pen, and then stored as paper records. However, when those forms are then scanned and stored electronically as PDF files, I will still refer to them as paper forms, regardless of the format of the archived ‘copy’.
Forms issued, completed AND stored electronically will be discussed later, as they generally have their own compliance requirements to address.
Good documentation practice is essential for all records required by a regulatory predicate rule. Some companies still refer to this as GDP, however, since the introduction of Good Distribution Practice, which claimed the GDP acronym, documentation regulations now use the term GDocP. 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”