行 GxP 之審

謀與行 GxP 之審於算系、資整之行、或規程。

用時

• 排之內審於已驗之算系
• 供者資之審於 GxP 關軟
• 察前備評於規審前
• 因之審由偏、訴、或資整之疑而發
• 已驗系之規態週察

入

• 必：審之範（系、程、或地）
• 必：適之規（21 CFR Part 11、EU Annex 11、GMP、GLP、GCP）
• 必：前審報與開之 CAPA
• 可選：系驗之書（URS、VP、IQ/OQ/PQ、追溯矩）
• 可選：SOP、訓錄、變控誌
• 可選：發審之特險處或疑

法

第一步：建審之謀

# 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 |

得： 審謀已得質管之准且於審前二週通於被審者。 敗則： 若被審者不能供所需書或人，改期。

第二步：行開會

序：

1. 引審團與職
2. 確範、程、物流
3. 明得分之系（危/重/微）
4. 確密約
5. 識被審之陪與書之守
6. 答問

得： 開會有書附到錄。 敗則： 若要員不得，改受影之活。

第三步：收察證

察書與錄對審之準：

3a. 驗書察

• URS 存且已准
• 驗謀合系類與險
• IQ/OQ/PQ 已行且果已書
• 追溯矩連求於測果
• 偏已書且解
• 驗總報已准

3b. 行控察

• SOP 現且已准
• 訓錄示諸用者之能
• 變控錄全（請、評、准、驗）
• 事/偏之報依 SOP 治
• 週察依期行

3c. 資整評

• 審跡啟且用者不可改
• 電簽合規
• 備與復之序已書且試
• 訪控執職之權
• 資可歸、可讀、當時、原、準（ALCOA+）

3d. 系設察

• 產設合已驗之態
• 用戶察——無共戶，閒戶禁
• 系鐘同且準
• 安補依已准之變控施

得： 證收為截圖、書副、訪記附時戳。 敗則： 錄「不可驗」為察而注由。

第四步：分所得

依重分每得：

Classification	Definition	Response Required
Critical	Direct impact on product quality, patient safety, or data integrity. Systematic failure of a key control.	Immediate containment + CAPA within 15 business days
Major	Significant departure from GxP requirements. Potential to impact data integrity if uncorrected.	CAPA within 30 business days
Minor	Isolated deviation from procedure. No direct impact on data integrity or product quality.	Correction within 60 business days
Observation	Opportunity for improvement. Not a regulatory requirement.	Optional — tracked for trend analysis

每得書：

## Finding F-[NNN]
**Classification:** [Critical / Major / Minor / Observation]
**Area:** [Audit trail / Access control / Change control / etc.]
**Reference:** [Regulatory clause, e.g., 21 CFR 11.10(e)]

**Observation:**
[Objective description of what was found]

**Evidence:**
[Document ID, screenshot reference, interview notes]

**Regulatory Expectation:**
[What the regulation requires]

**Risk:**
[Impact on data integrity, product quality, or patient safety]

得： 每得有分、證、規引。 敗則： 若分有爭，升於審程之管以裁。

第五步：行閉會

序：

1. 示所得之摘（不應新得於此升）
2. 察得之分
3. 議初 CAPA 之期望與期
4. 確後步與報期
5. 謝被審之合

得： 閉會書附到。被審者認之（認 ≠ 同）。 敗則： 若被審爭得，書異而依 SOP 升。

第六步：書審報

# Audit Report
## Document ID: AR-[SYS]-[YYYY]-[NNN]

### 1. Executive Summary
An audit of [System/Process] was conducted on [dates] against [regulations].
[N] findings were identified: [n] critical, [n] major, [n] minor, [n] observations.

### 2. Scope and Methodology
[Summarize audit plan scope, criteria, and methods used]

### 3. Findings Summary
| Finding ID | Classification | Area | Brief Description |
|-----------|---------------|------|-------------------|
| F-001 | Major | Audit trail | Audit trail disabled for batch record module |
| F-002 | Minor | Training | Two users missing annual GxP training |
| F-003 | Observation | Documentation | SOP formatting inconsistencies |

### 4. Detailed Findings
[Include full finding details from Step 4 for each finding]

### 5. Positive Observations
[Document areas of good practice observed during the audit]

### 6. Conclusion
The overall compliance status is assessed as [Satisfactory / Needs Improvement / Unsatisfactory].

### 7. Distribution
| Recipient | Role |
|-----------|------|
| [Name] | System Owner |
| [Name] | QA Director |
| [Name] | IT Manager |

### Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Lead Auditor | | | |
| QA Director | | | |

得： 報於閉會後十五工日內發。 敗則： 若遲逾十五日，告相關而書由。

第七步：追 CAPA 而驗效

每需 CAPA 之得：

## CAPA Tracking
| Finding ID | CAPA ID | Root Cause | Corrective Action | Due Date | Status | Effectiveness Check |
|-----------|---------|------------|-------------------|----------|--------|-------------------|
| F-001 | CAPA-2025-042 | Configuration oversight during upgrade | Enable audit trail, verify all modules | 2025-04-15 | Open | Scheduled 2025-07-15 |
| F-002 | CAPA-2025-043 | Training matrix not updated | Complete training, update tracking | 2025-05-01 | Open | Scheduled 2025-08-01 |

得： CAPA 已分、追、依期驗效。 敗則： 未解 CAPA 升於 QA 管且標於下審周。

驗

• 審謀已准且於審前通
• 開閉會書附到
• 證附時戳與源引
• 每得有分、證、規引
• 審報於十五工日內發
• 諸危重得有期之 CAPA
• 前審之 CAPA 已驗閉效

陷

• 範蔓：審中擴範無正約，生不全之涵與爭。
• 意之得：得必引特規，非私好。
• 敵語：審乃共質改之事，非訊。
• 忽善：只報得而不認善實損信。
• 無效察：閉 CAPA 而不驗修真行乃常規之引。

參

• perform-csv-assessment — 全 CSV 生命之評（URS 至驗總）
• setup-gxp-r-project — 驗之 R 境之項目構
• implement-audit-trail — 電錄之審跡之實
• write-validation-documentation — IQ/OQ/PQ 之儀與報之書
• security-audit-codebase — 安專之碼審（補之觀）