conduct-gxp-audit
Installation
SKILL.md
Conduct GxP Audit
Plan and execute a GxP audit of computerized systems, data integrity practices, or regulated processes.
When to Use
- Scheduled internal audit of a validated computerized system
- Supplier/vendor qualification audit for GxP-relevant software
- Pre-inspection readiness assessment before a regulatory audit
- For-cause audit triggered by a deviation, complaint, or data integrity concern
- Periodic review of a validated system's compliance posture