| name | conduct-gxp-audit-2 |
| title | 行 GxP 稽核 |
| description | 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. |
| author | pjt222 |
| author_url | https://github.com/pjt222/agent-almanac/tree/main/i18n/wenyan-lite/skills/conduct-gxp-audit |
| license | MIT |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | general |
| practice | life-sciences |
| language | zh |
行 GxP 稽核
規劃並行電腦化系統、數據完整性實踐、或受規流程之 GxP 稽核。
適用時機
- 受驗電腦化系統之定期內部稽核
- GxP 相關軟體之供應商資格稽核
- 法規稽核前之備查評估
- 偏差、投訴、數據完整性疑慮觸發之因由稽核
- 受驗系統之合規姿態之定期審
輸入
- 必要：稽核範圍（受稽之系統、流程、或場址）
- 必要：適用法規（21 CFR Part 11、EU Annex 11、GMP、GLP、GCP）
- 必要：先前稽核報告與未結 CAPA 項
- 選擇性：系統驗證文件（URS、VP、IQ/OQ/PQ、可追蹤矩陣）
- 選擇性：SOP、訓練記錄、變更控制日誌
- 選擇性：觸發稽核之具體風險或疑慮
步驟
步驟一：擬稽核計畫
# Audit Plan
## Document ID: AP-[SYS]-[YYYY]-[NNN]
### 1. Objective
[State the purpose: scheduled, for-cause, supplier qualification, pre-inspection]
### 2. Scope
- **System/Process**: [Name and version]
- **Regulations**: [21 CFR Part 11, EU Annex 11, ICH Q7, etc.]
- **Period**: [Date range of records under review]
- **Exclusions**: [Any areas explicitly out of scope]
### 3. Audit Criteria
| Area | Regulatory Reference | Key Requirements |
|------|---------------------|------------------|
| Electronic records | 21 CFR 11.10 | Controls for closed systems |
| Audit trail | 21 CFR 11.10(e) | Secure, computer-generated, time-stamped |
| Electronic signatures | 21 CFR 11.50 | Manifestation, legally binding |
| Access controls | EU Annex 11, §12 | Role-based, documented |
| Data integrity | MHRA guidance | ALCOA+ principles |
| Change control | ICH Q10 | Documented, assessed, approved |
### 4. Schedule
| Date | Time | Activity | Participants |
|------|------|----------|-------------|
| Day 1 AM | 09:00 | Opening meeting | All |
| Day 1 AM | 10:00 | Document review | Auditor + QA |
| Day 1 PM | 13:00 | System walkthrough | Auditor + IT + System Owner |
| Day 2 AM | 09:00 | Interviews + evidence collection | Auditor + Users |
| Day 2 PM | 14:00 | Finding consolidation | Auditor |
| Day 2 PM | 16:00 | Closing meeting | All |
### 5. Audit Team
| Role | Name | Responsibility |
|------|------|---------------|
| Lead Auditor | [Name] | Plan, execute, report |
| Subject Matter Expert | [Name] | Technical assessment |
| Auditee Representative | [Name] | Facilitate access and information |
