The categories are designed to reflect the risk and complexity of the software being used. Description Infrastructure Software

The goal of GAMP software categories is .

4️⃣ (Category 4) The sweet spot for many LIMS or CDS systems. The core software is standard (off-the-shelf), but you configure it to meet your specific process needs (e.g., defining specific workflows, creating custom reports).

The GAMP software category system is not a bureaucratic exercise—it directly reduces patient safety and product quality risks. By correctly assigning Category 3 (non-configured), 4 (configured), or 5 (custom), organizations can scale validation efforts appropriately, saving time and ensuring regulatory compliance.

Operating systems, databases, networks, and Infrastructure as Code (IaC) 0.5.12. Non-Configurable Software

You can use this content to draft a full paper (e.g., 2–5 pages).