Gamp 5 Categories Of Software Fix
| Category | Type | Can you configure it? | Validation Effort | Typical Example | | :--- | :--- | :--- | :--- | :--- | | | Infrastructure | No | Minimal (Qualification) | Windows OS | | 3 | Non-Configured | No (just basic setup) | Low | Basic digital scale | | 4 | Configured | Yes (using built-in tools) | High | LIMS, EDMS, ERP | | 5 | Custom/Bespoke | N/A (you write the code) | Very High | In-house Python script |
Category 4 is perhaps the most common software type in the pharmaceutical and medical device industries. It includes complex software packages that provide standard interfaces and functions but must be configured to meet specific business needs. Examples include Enterprise Resource Planning (ERP) systems, Laboratory Information Management Systems (LIMS), and Supervisory Control and Data Acquisition (SCADA) systems. gamp 5 categories of software
| Category | Configurability | Risk Level | Validation Intensity | Key Deliverable | | :--- | :--- | :--- | :--- | :--- | | | N/A (Platform) | Low | IQ Only | Installation Verification | | 3. Standard | None (As-is) | Low | IQ + UAT | Black Box Testing | | 4. Configured | High (No Code) | Medium/High | Full IQ/OQ/PQ | Config Specs & Testing | | 5. Custom | N/A (Code Written) | Very High | Full SDLC | Code Review & Unit Testing | | Category | Type | Can you configure it
If you work in pharmaceutical, biotech, or medical device manufacturing, you’ve likely heard the phrase “GAMP 5” thrown around in validation meetings. But what does it actually mean for the software on your desk or the code running your production line? Configured | High (No Code) | Medium/High |
Validation for Category 4 requires a more detailed approach. Users must document the configuration specifications, which detail how the software was set up (e.g., defining user roles, setting workflow parameters, or creating report templates). Testing must then demonstrate that the specific configuration works as intended and handles data accurately according to the defined business process. Category 5: Custom Software
Category 2 (Firmware) was removed in GAMP 5 because modern firmware is now complex enough to fit into the other categories based on its function. RxERP +1 Category Type Description Examples Risk Level Category 1 Infrastructure Software Foundational software used to run other applications. Not configured for specific business processes. Operating systems (Windows, Linux), databases (Oracle, SQL), antivirus, firewalls. Low Category 3 Non-Configured Products Off-the-shelf software used "as installed" without customization or changes to match business processes. Lab instrument control software, static data viewers, simple firmware. Low to Moderate Category 4 Configured Products Software that can be tailored to specific needs using built-in vendor tools (no code changes). LIMS, ERP (SAP), SCADA, MES, Warehouse Management Systems. Moderate Category 5 Custom Applications Bespoke software developed in-house or by a third party specifically for a business need. Custom database scripts, bespoke instrument interfaces, complex Excel macros. High Key Differences and Validation Focus 10 sites GAMP 5 Categories Explained: Validation Guide (2025) Dec 5, 2025 —
Are we configuring this, or just installing it? The answer will define your validation strategy.