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
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 The following reflects the traditional categories 1, 3, 4, and 5 (Category 2 is obsolete).
By correctly identifying a system as Category 3 instead of Category 5, a company can save hundreds of hours in unnecessary documentation. Conversely, misidentifying a Category 5 system as Category 3 is a major compliance risk that could lead to "Warning Letters" during an audit.
A workbook using intricate VBA macros to calculate drug dosages. gamp 5 categories with examples
Complex software where the "out of the box" version is tailored to fit a business process via a configuration interface.
These are "off-the-shelf" (OTS) software packages that are used exactly as they are provided by the vendor. You might enter data into them, but you aren't changing how the software itself functions.
Here is a deep dive into the GAMP 5 categories with real-world examples. Category 1: Infrastructure Software The following reflects the traditional categories 1, 3,
Record the version and verify installation. You don’t need to "validate" Microsoft Windows, but you must prove it is installed correctly. Examples: Operating Systems: Windows 11, Linux, iOS. Database Engines: Oracle, Microsoft SQL Server, MySQL. Network Tools: Firewalls, routers, and antivirus software. Category 2: (Discontinued)
The full lifecycle is required. This includes formal Design Specifications, Code Reviews, Unit Testing, and rigorous Functional/User Acceptance Testing. Examples:
These are the foundational tools that manage the environment in which your applications run. They are not specific to your business process, but the system cannot function without them. A workbook using intricate VBA macros to calculate
Commercially available software that can be configured (via parameters, settings, or modules) to meet specific business or quality processes. Most GxP-relevant systems fall here. Validation must cover both the software's functions and the configuration. Examples:
Configuring specific sample workflows.
Bespoke software, custom macros, or scripts written in languages like Python, C#, or VBA.