Here are 5 categories of games with examples:

Understanding GAMP 5 Categories: A Comprehensive Guide If you work in a regulated industry like pharmaceuticals or medical devices, you’ve likely encountered (Good Automated Manufacturing Practice, 5th Edition). It is the "gold standard" framework for ensuring that computerized systems are fit for their intended use and compliant with regulations like FDA 21 CFR Part 11.

A workbook using intricate VBA macros to calculate drug dosages.

GAMP 5 (2nd Edition) has moved toward a risk-based approach rather than rigid categories. However, the legacy categorization is still widely used in industry for practical classification. The following reflects the traditional categories 1, 3, 4, and 5 (Category 2 is obsolete).

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:

Category 3 software refers to standard commercial off-the-shelf (COTS) products that are used "as-is" without customization of the underlying code or complex configuration. GAMP 5 Categories Explained: Software, Risk & Examples