GAMP 5 provides guidance, including establishing a common language and terminology for computerized systems. This guidance includes the definition of GAMP Software Categories. These categories are used to classify the software component of a computerized system. The level of validation activities and deliverables can be derived from these categories.
The GAMP software categories are:
- Category 1: Infrastructure software. This includes IT Infrastructure tools, layer software such as operating systems (OS), databases (DB), and middleware.
- Category 2: This category is no longer used.
- Category 3: Non-configured Products. Examples include firmware-based applications, COTS (Commercial Off-The-Shelf) software, and instruments.
- Category 4: Configured Products. This category covers systems like ERP (Enterprise Resource Planning), EDMS (Electronic Document Management Systems), LIMS (Laboratory Information Management Systems), and spreadsheets.
- Category 5: Custom Applications. Examples of this category are dedicated applications, custom firmware, and spreadsheets that use macros.
A Manufacturing Execution System (MES) is described as falling into Category 4 according to GAMP 5, while customizations to such a system are considered Category. The validation approach for the MES system is based on its classification into SW Category 4-5 according to GAMP
