Gamp 5 Software Categories ((exclusive))

Here is a deep dive into the four active GAMP 5 software categories and how to apply them. Why Categorize Software?

*Simplified risk assessment **Infrastructure qualification applies separately gamp 5 software categories

four active software categories (Category 2 was retired as it primarily covered obsolete firmware). Scribd +1 GAMP 5 Software Categories Overview Category Type Description Examples Category 1 Infrastructure Software Core software that provides the hosting environment. It is typically not modifiable by end users. Operating systems (Windows, Linux), databases (SQL, Oracle), and network monitoring tools. Category 3 Non-Configured Products Off-the-shelf software used "as installed." While you can enter parameters (like a username), the underlying code and business logic are fixed. Simple calculators, standard lab instruments, and basic commercial applications. Category 4 Configured Products Commercial software that is adjusted through configuration settings or business rules to meet specific user needs, without changing the source code. LIMS (Laboratory Information Management Systems), ERPs (SAP), and SCADA systems. Category 5 Custom Applications Bespoke software written from scratch for a specific organization or heavily modified open-source tools. Custom-coded interfaces, in-house developed apps, and complex Excel spreadsheets with VBA macros. Key Principles of the GAMP 5 Framework The goal of these categories is to support the five foundational principles of the GAMP 5: Scilife +1 Product and Process Understanding Here is a deep dive into the four

ERP systems (SAP, Oracle).

You do not "validate" the software itself. Instead, you verify installation and maintain version control. Documentation is typically limited to an inventory list and proof of installation/patch management. Category 2: (Discontinued) Scribd +1 GAMP 5 Software Categories Overview Category