GAMP 5 encourages "leveraging supplier documentation." It explicitly states that if a supplier has a robust Quality Management System (QMS) and validated software, the user company does not need to recreate those documents. Instead, the user verifies that the supplier’s work meets their specific requirements. This reduces duplication of effort and fosters a partnership model rather than an adversarial auditing model.
While GAMP 4 touched on electronic records, it predated the intense regulatory scrutiny regarding Data Integrity (ALCOA+ principles) that emerged in the 2010s. difference between gamp 4 and gamp 5
📎 GAMP 5 – Lean Validation Template for CDS GAMP 5 encourages "leveraging supplier documentation
While GAMP 4 focused heavily on documentation and rigid processes, GAMP 5 pivoted toward science-based risk management and the concept of "fitness for purpose." This article explores the critical differences between the two versions and what they mean for validation professionals. While GAMP 4 touched on electronic records, it
GAMP 4 was written in an era where regulators and industry alike sought a checklist approach to compliance. It was heavily prescriptive, outlining specific documents and steps required for validation. The mindset was often, "If we produce this document, we are compliant." While effective at standardizing practices, it often led to a "tick-the-box" mentality where the volume of documentation became a proxy for quality.
