МИЛОРАД Радов НИКОЛИЋ
Саучешће примамо у капели у Страшевини дана 09.03. од 11 до 16 часова и дана 10.03.2026. године од 11 до 14 часова, када се креће за село Броћанац гдје ће се обавити сахрана у 15 часова.
ОЖАЛОШЋЕНИ:
Gamp 4 Category May 2026
The team treated Category 4 as a pure black-box, assuming all configurable parameters were benign. They lacked a parameter criticality assessment .
Six months post-deployment, an operator discovered that by changing a single dropdown setting from "Mandatory data entry" to "Optional," they could skip a critical weigh-check step. This parameter was not included in the original OQ because it was considered "non-configurable" by the validation team. gamp 4 category
Configuration and Risk Management of GAMP Category 4 Software: Moving Beyond Black-Box Validation The team treated Category 4 as a pure
| Feature | GAMP Category 4 (Configured) | GAMP Category 5 (Custom/Bespoke) | | :--- | :--- | :--- | | | None (no source code changes) | Yes (new code written) | | Configuration | Parameter setting, tables, workflows | Not applicable or minimal | | Supplier role | Provide standard product + config tools | Provide development services | | Validation risk | Medium (focused on correct config) | High (requires unit/integration testing) | | Reusability of evidence | High (supplier documentation) | Low (project-specific) | This parameter was not included in the original
A pharmaceutical manufacturer implemented a GAMP Category 4 Manufacturing Execution System to enforce electronic batch record workflows. During validation, they tested all "happy path" configurations.
