Conduct Gxp Audit
技能 已验证 活跃Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical/major/minor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.
To guide users through the systematic planning, execution, and reporting of GxP audits for computerized systems and regulated processes, ensuring compliance and data integrity.
功能
- Detailed GxP audit planning and execution steps
- Templates for audit plans, findings, and reports
- Guidance on finding classification (critical/major/minor)
- Framework for CAPA generation and tracking
- Coverage for various audit types (scheduled, for-cause, supplier)
使用场景
- Conducting scheduled internal audits of validated systems
- Performing supplier qualification audits for GxP software
- Preparing for regulatory inspections with readiness assessments
- Investigating deviations or data integrity concerns with for-cause audits
非目标
- Performing the audit automatically without user input or LLM interaction
- Providing legal interpretation of GxP regulations
- Replacing formal GxP training programs
安装
/plugin install agent-almanac@pjt222-agent-almanac质量评分
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