The GPGs share a common philosophy derived from GAMP 5:
The primary objective of the GAMP Good Practice Guide is to ensure and patient safety throughout the entire system lifecycle. Historically, software validation was often treated as a burdensome, document-heavy exercise performed just before a system went live. The GAMP guide revolutionized this approach by introducing a lifecycle model based on the "V-model" (or its agile adaptations). This model links specific design and development activities directly to corresponding verification and testing phases. By establishing clear user requirements, functional specifications, and design specifications upfront, the guide ensures that testing is not an afterthought but a continuous verification that the system does exactly what it is intended to do—and, crucially, what it is not intended to do. gamp good practice guide
This guide addresses the complex interface between shop-floor equipment and enterprise resource planning (ERP). It focuses on: The GPGs share a common philosophy derived from
October 26, 2023 Subject: Overview and Analysis of the GAMP® Good Practice Guide Series Prepared For: General Audience / Quality Assurance / Regulatory Affairs This model links specific design and development activities
Implementing the practices found in GPGs offers several tangible benefits: