Non-GxP systems do not affect product quality, patient safety, or regulatory decisions.
Validation effort here is minimal or not required.
Examples:
- HR management systems
- Visitor management systems
- Finance & Payroll systems
- Office productivity tools (email, scheduling)
Reference: ISPE GAMP 5 — Appendix M4 (System Categorization).
How to Differentiate GxP and Non-Gxp?
There are 3 types of impact:
- Direct Impact: System directly controls a critical manufacturing parameter (temp, pressure). → High GxP
- Indirect Impact: System supports a process that influences decisions (LIMS, QMS). → Medium GxP
- No Impact: Doesn’t affect decisions or quality at all. → Non-GxP
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