Gamp 5 Categories With Examples __link__

GAMP 5 Software Categorization: A Risk-Based Framework for System Validation

| Category | Type | Example | Validation Intensity | | :--- | :--- | :--- | :--- | | | Infrastructure Software | Windows OS, Anti-virus | IT Practices, no full validation | | 3 | Non-Configurable | Firmware on a pH meter | Low (user requirements + testing) | | 4 | Configurable | Configured LIMS, SAP, SCADA | Medium (focus on configuration testing) | | 5 | Custom/Bespoke | In-house Python script, custom PLC code | High (full SDLC, code reviews) | gamp 5 categories with examples

four active categories (Categories 1, 3, 4, and 5). Category 2 is no longer in use. QbD Group +2 Category Type Description Risk Level 1 Infrastructure Software Foundational software that creates the operating environment. Low 3 Non-Configured Products Off-the-shelf software used "as installed" without customization. Moderate/Low 4 Configured Products Standard software tailored to specific workflows through built-in tools. Moderate 5 Custom Applications Bespoke software developed uniquely for a specific business need. High 1. Infrastructure Software This category includes the "plumbing" of an IT system—core components that support applications but do not contain business-specific logic. IntuitionLabs +1 Examples: Operating systems (Windows, Linux), Database Management Systems (Oracle, SQL Server), Network software (firewalls, antivirus), and Middleware. Validation Approach: Focuses on proper installation, version control, and qualification of the infrastructure itself rather than the application running on it. IntuitionLabs +2 2. [Obsolete] This category previously covered firmware for simple instruments in GAMP 4. It was removed in GAMP 5 because modern firmware can be as complex as standalone software. Yaveon GmbH +2 3. Non-Configured Products These are Commercial Off-the-Shelf (COTS) products that satisfy requirements without modification to the code or configuration. Entering run-time parameters (like a setpoint) is allowed, but the underlying functionality remains fixed. IntuitionLabs +1 Examples: Laboratory instruments with embedded firmware (e.g., pH meters), basic data acquisition tools, or standard software used exactly as provided by the vendor. Validation Approach: Verification focuses on confirming the system meets user requirements through installation (IQ) and operational (OQ) qualification. IntuitionLabs +2 4. Configured Products This is the most common category for enterprise systems. The software is standardized but has built-in tools that allow users to configure business rules, workflows, or screen layouts without writing custom code. IntuitionLabs +1 10 sites GAMP categories for computerized systems - QbD Group Jan 19, 2022 — GAMP 5 Software Categorization: A Risk-Based Framework for