Configuring a clinical trial database with specific fields and validations. Category 5: Custom Applications
Good Automated Manufacturing Practice (GAMP) 5 provides a framework for the validation of computerized systems in regulated life science industries. A core component of this framework is the classification of software into specific categories, which dictates the scope and intensity of validation efforts. This paper outlines the four active GAMP 5 categories—Infrastructure Software, Non-Configured Products, Configured Products, and Custom Applications—providing technical definitions and real-world examples for each. 1. Introduction to GAMP 5 gamp 5 categories with examples
GAMP 5 Software Categorization: A Risk-Based Framework for System Validation Configuring a clinical trial database with specific fields
Hemen Ulaşın