The story only concludes when the system is no longer used. Key Concepts in the GAMP4 Narrative Introduction to GAMP4 - SlideServe
| Left Side (Planning & Design) | The Apex | Right Side (Testing & Release) | | :--- | :---: | :--- | | User Requirements Specification (URS) | | User Acceptance Testing (UAT) | | Functional Specification (FS) | | Integration Testing | | Design Specification (DS) | | Module/Unit Testing | | | Build | Code Review / Verification | The story only concludes when the system is no longer used
It shifted focus from strictly "manufacturing" to all systems that could impact patient safety, product quality, and data integrity. and data integrity.