This section defines system scope, applies GAMP-based risk principles, and establishes how supplier capability influences validation strategy and documentation depth.
1. Purpose This article defines a risk-based approach for identifying and classifying computerized systems used in regulated environments. Classification determines validation scope, testing depth, and lifecycle controls based on system impact, complexity, and data criticality. 2. Scope of Computerized Systems…
1. Purpose This article provides an overview of GAMP 5 and its role in the validation of computerized systems used in regulated environments. It establishes the fundamental principles used to ensure that systems are fit for intended use and that…
1. Purpose This article defines the GAMP 5 software category model and explains how software categorization is used to determine validation approach, testing depth, and documentation requirements. Software categorization is a key decision step. It establishes how systems are verified…
1. Purpose This article defines a structured approach for supplier assessment and vendor qualification of computerized systems. It establishes how supplier capability is evaluated and how supplier activities may be leveraged to support validation. Supplier assessment is a critical control….