Demystifying GAMP 5 Software Categories: A Guide for Regulated Industries
Best for: A visual slide or a quick reference sheet for your team.
Operating systems (Windows, Linux), Database engines (SQL, Oracle), and network monitoring tools. gamp software category
As the category number goes up, the validation effort and risk increase.
Internally developed Excel macros, custom-coded interfaces between two systems, or a unique SCADA setup. Demystifying GAMP 5 Software Categories: A Guide for
3️⃣ (Category 3) "Off-the-shelf" and locked. Standard tools like calculators or media players. No code changes allowed here. Focus: User Requirements and functionality checks.
Under GAMP 5, software is divided into four main categories (Category 2 was removed from previous versions as it was deemed redundant). Category 1: Infrastructure Software No code changes allowed here
| Category | Name | Description | Validation Focus | Example | |----------|------|-------------|------------------|---------| | | Infrastructure Software | Operating systems, database managers, spreadsheet software (standard, non-configured) | Record version, test basic compatibility | Windows, Excel (used as a calculator) | | 2 | Removed (formerly Firmware) | No longer used as a separate category | N/A | Legacy systems only | | 3 | Non-Configured Software | Commercial off-the-shelf (COTS) with standard settings; no configuration to meet business process | Test against user requirements | Lab instrument firmware, simple barcode readers | | 4 | Configured Software | COTS that is configured (e.g., via parameters, workflows) to match specific business processes | High: test configuration, security, data integrity | ERP (SAP), LIMS, Electronic Batch Records (EBR) | | 5 | Custom/Bespoke Software | Software designed and coded specifically for the organization | Highest: code review, unit/integration testing, full SDLC | In-house Python script, custom manufacturing execution system (MES) |
This category represents the highest risk. These are bespoke systems designed specifically for your company, or existing systems with heavy custom coding.
Identifying the correct category isn't just a box-ticking exercise—it determines the scope of your project.
LIMS (Laboratory Information Management Systems), ERPs (like SAP), and Quality Management Systems (QMS).