perform-csv-assessment
About
This skill performs Computer Systems Validation (CSV) assessments using GAMP 5 methodology for GxP-regulated environments. It handles user requirements, risk analysis, IQ/OQ/PQ planning, traceability matrices, and validation reporting. Use it when introducing new systems, making major changes, during revalidation, or for regulatory gap analyses.
Quick Install
Claude Code
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Documentation
行 CSV 評估
於受規環境，依 GAMP 5 風險為本之方法論行電腦系統驗證評估。
適用時機
- GxP 環境中將引入新電腦化系統
- 既有經驗證系統正歷重大變更
- 須行定期重驗證
- 法規檢查在即，須驗證缺口分析
輸入
- 必要：系統描述（名、用途、廠商、版本）
- 必要：擬用聲明與法規上下文（GxP 範圍）
- 必要：GAMP 5 軟體類別（1–5）
- 選擇性：既有用戶需求規格（URS）
- 選擇性：廠商文件（設計規格、發布說明、SOP）
- 選擇性：先前驗證文件
步驟
步驟一：辨 GAMP 5 軟體類別
將系統分類：
| Category | Type | Example | Validation Effort |
|---|---|---|---|
| 1 | Infrastructure software | OS, firmware | Low — verify installation |
| 3 | Non-configured product | COTS as-is | Low-Medium — verify functionality |
| 4 | Configured product | LIMS with config | Medium-High — verify configuration |
| 5 | Custom application | Bespoke R/Shiny app | High — full lifecycle validation |
預期： 類別已明賦並記理據。 失敗時： 若類別模糊，預設較高類別並記理據。
步驟二：寫用戶需求規格（URS）
建附編號需求之 URS 文件：
# User Requirements Specification
## System: [System Name] v[Version]
## Document ID: URS-[SYS]-[NNN]
### 1. Purpose
[Intended use statement]
### 2. Functional Requirements
| ID | Requirement | Priority | Source |
|----|-------------|----------|--------|
| URS-001 | System shall calculate BMI from height and weight inputs | Must | Regulatory SOP-xxx |
| URS-002 | System shall generate audit trail entries for all data changes | Must | 21 CFR 11.10(e) |
| URS-003 | System shall export results in PDF format | Should | User request |
### 3. Non-Functional Requirements
| ID | Requirement | Priority | Source |
|----|-------------|----------|--------|
| URS-010 | System shall respond within 3 seconds for standard queries | Should | Usability |
| URS-011 | System shall restrict access via role-based authentication | Must | 21 CFR 11.10(d) |
### 4. Data Integrity Requirements
[ALCOA+ requirements: Attributable, Legible, Contemporaneous, Original, Accurate]
### 5. Regulatory Requirements
[Specific 21 CFR Part 11, EU Annex 11, or other applicable requirements]
預期： 所有需求皆有獨立 ID、優先級與對源之追溯。 失敗時： 對無清晰來源或優先級之需求，標予利害關係人審。
步驟三：行風險評估
施 GAMP 5 風險為本之法，用 Failure Mode and Effects Analysis（FMEA）：
# Risk Assessment
## Document ID: RA-[SYS]-[NNN]
| Req ID | Failure Mode | Severity (1-5) | Probability (1-5) | Detectability (1-5) | RPN | Risk Level | Mitigation |
|--------|-------------|----------------|-------------------|---------------------|-----|------------|------------|
| URS-001 | Incorrect BMI calculation | 4 | 2 | 1 | 8 | Low | OQ test case |
| URS-002 | Audit trail entries missing | 5 | 3 | 3 | 45 | High | IQ + OQ + monitoring |
| URS-011 | Unauthorized access | 5 | 2 | 2 | 20 | Medium | OQ test + periodic review |
Risk Priority Number（RPN）= Severity x Probability x Detectability。
| RPN Range | Risk Level | Testing Requirement |
|---|---|---|
| 1–12 | Low | Basic verification |
| 13–36 | Medium | Documented test case |
| 37+ | High | Full IQ/OQ/PQ with retest |
預期： 每 URS 需求皆有對應之風險評估列。 失敗時： 將未評之需求上呈驗證主導者後再行。
步驟四：定驗證策略（驗證計劃）
# Validation Plan
## Document ID: VP-[SYS]-[NNN]
### Scope
- System: [Name] v[Version]
- GAMP Category: [N]
- Validation approach: [Prospective / Retrospective / Concurrent]
### Qualification Stages
| Stage | Scope | Applies? | Rationale |
|-------|-------|----------|-----------|
| IQ | Installation correctness | Yes | Verify installation, dependencies, configuration |
| OQ | Operational requirements | Yes | Verify functional requirements from URS |
| PQ | Performance under real conditions | [Yes/No] | [Rationale] |
### Roles and Responsibilities
| Role | Name | Responsibility |
|------|------|---------------|
| Validation Lead | [Name] | Plan, coordinate, approve |
| Tester | [Name] | Execute test scripts |
| System Owner | [Name] | Approve for production use |
| QA | [Name] | Review and sign-off |
### Acceptance Criteria
- All critical test cases pass
- No unresolved critical or major deviations
- Traceability matrix complete
預期： 測試執行前，驗證計劃經所有利害關係人核准。 失敗時： 無經核准之驗證計劃即不行測試執行。
步驟五：建測試協議（IQ/OQ/PQ）
為每資格階段寫測試腳本：
# Operational Qualification Protocol
## Test Case: TC-OQ-001
## Traces to: URS-001
**Objective:** Verify BMI calculation accuracy
**Prerequisites:**
- System installed per IQ protocol
- Test data set prepared
**Test Steps:**
| Step | Action | Expected Result | Actual Result | Pass/Fail |
|------|--------|-----------------|---------------|-----------|
| 1 | Enter height=180cm, weight=75kg | BMI displayed as 23.15 | | |
| 2 | Enter height=160cm, weight=90kg | BMI displayed as 35.16 | | |
| 3 | Enter height=0, weight=75kg | Error message displayed | | |
**Tester:** _________ Date: _________
**Reviewer:** _________ Date: _________
預期： 每中與高風險需求皆至少有一測試案。 失敗時： 執行始前加缺漏之測試案。
步驟六：建追溯矩陣
建需求追溯矩陣（RTM），連每需求經風險評估至測試案：
# Traceability Matrix
## Document ID: TM-[SYS]-[NNN]
| URS ID | Requirement | Risk Level | Test Case(s) | Test Result | Status |
|--------|-------------|------------|--------------|-------------|--------|
| URS-001 | BMI calculation | Low | TC-OQ-001 | Pass | Verified |
| URS-002 | Audit trail | High | TC-IQ-003, TC-OQ-005 | Pass | Verified |
| URS-003 | PDF export | Low | TC-OQ-008 | Pass | Verified |
| URS-011 | Role-based access | Medium | TC-OQ-010, TC-OQ-011 | Pass | Verified |
預期： 100% URS 需求現於追溯矩陣中，附連結之測試結果。 失敗時： 任何未連測試結果之需求皆標為驗證缺口。
步驟七：寫驗證摘要報告
# Validation Summary Report
## Document ID: VSR-[SYS]-[NNN]
### 1. Executive Summary
[System name] v[version] has been validated in accordance with [VP document ID].
### 2. Validation Activities Performed
| Activity | Document ID | Status |
|----------|-------------|--------|
| User Requirements | URS-SYS-001 | Approved |
| Risk Assessment | RA-SYS-001 | Approved |
| Validation Plan | VP-SYS-001 | Approved |
| IQ Protocol/Report | IQ-SYS-001 | Executed — Pass |
| OQ Protocol/Report | OQ-SYS-001 | Executed — Pass |
| Traceability Matrix | TM-SYS-001 | Complete |
### 3. Deviations
| Dev ID | Description | Impact | Resolution |
|--------|-------------|--------|------------|
| DEV-001 | [Description] | [Impact assessment] | [Resolution and rationale] |
### 4. Conclusion
The system meets all user requirements as documented in [URS ID]. The validation is considered [Successful / Successful with conditions].
### 5. Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Validation Lead | | | |
| System Owner | | | |
| Quality Assurance | | | |
預期： 報告引所有驗證交付物，附明確之通過/失敗結論。 失敗時： 若偏差未解，報告當以「有條件」狀態記之，附 CAPA 引用。
驗證
- GAMP 5 類別已賦予並具理據
- URS 有編號需求、優先級與對源之追溯
- 風險評估覆蓋所有 URS 需求
- 測試執行前驗證計劃已核准
- 測試協議有前提、步驟、預期結果與簽署欄
- 追溯矩陣連每需求於風險與測試結果
- 驗證摘要報告記諸活動、偏差與結論
- 所有文件皆有獨立文件 ID 與版本控制
常見陷阱
- 過度驗證：將類別 5 之力施於類別 3 軟體，浪費資源。力與風險相應。
- 追溯缺漏：不能追溯至測試案之需求乃隱形缺口。
- 無計劃即測試：驗證計劃核准前執行測試使結果無效。
- 忽略非功能需求：安全、性能與資料完整性需求常被忽。
- 靜態驗證：將驗證視為一次性事件。變更需重評。
相關技能
setup-gxp-r-project— 經驗證 R 環境之專案結構write-validation-documentation— IQ/OQ/PQ 協議與報告寫作implement-audit-trail— 電子記錄之審計追蹤實施validate-statistical-output— 統計輸出驗證方法conduct-gxp-audit— 經驗證系統之稽核
GitHub Repository
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