This is the most common category in the Life Sciences. These systems provide standard functions, but they allow the user to configure specific workflows, data structures, or business rules without changing the underlying software code.
Note: In the transition from GAMP 4 to GAMP 5, Category 2 (Firmware) was removed. Most items previously in this category were moved to Category 3 or 4. Category 3: Non-Configured Products
Standard, off-the-shelf software that is used "out of the box." No configuration of the software itself is possible or allowed. Validation focuses on user requirements and testing of standard functions. Examples:
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
This is the most common category in the Life Sciences. These systems provide standard functions, but they allow the user to configure specific workflows, data structures, or business rules without changing the underlying software code.
Note: In the transition from GAMP 4 to GAMP 5, Category 2 (Firmware) was removed. Most items previously in this category were moved to Category 3 or 4. Category 3: Non-Configured Products gamp 5 categories with examples
Standard, off-the-shelf software that is used "out of the box." No configuration of the software itself is possible or allowed. Validation focuses on user requirements and testing of standard functions. Examples: This is the most common category in the Life Sciences
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 Most items previously in this category were moved