Gamp Ispe Exclusive Today

The primary objective remains consistent: to encourage the creation of effective, reliable, and high-quality computerized systems through a cost-effective and efficient framework . The Core Principle: A Risk-Based Approach

| Category | Type | Example | |----------|------|---------| | 1 | Infrastructure software | OS, DB, antivirus | | 3 | Non-configurable | Off-the-shelf (e.g., printer driver) | | 4 | Configurable | ERP, LIMS, DMS | | 5 | Custom/Bespoke | In-house developed app | gamp ispe