This category covers the foundational software required to run application systems. It is rarely modified by the end-user and is typically qualified rather than fully validated, as the validation focus remains on the applications it hosts.
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: gamp 5 categories with examples
These are systems built from scratch or contain custom-coded modules to meet unique business needs. This category carries the highest risk because the "code" is unique to your company. This category covers the foundational software required to
| 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) | Most GxP-relevant systems fall here
Software for a simple pH meter or a digital scale.