Gamp 4 Category [FAST]

Because the vendor manages the core code, the system is generally more stable. Bugs in the core code are fixed by the vendor (and shared across the user base), whereas bugs in custom code (Category 5) are yours to fix alone.

Upgrading a highly customized system is a nightmare. Custom code often breaks when the core software is updated. Category 4 systems generally have smoother upgrade paths because the configurations are supported by the vendor’s standard upgrade procedures. gamp 4 category

Configuration and Risk Management of GAMP Category 4 Software: Moving Beyond Black-Box Validation Because the vendor manages the core code, the