| name | prepare-inspection-readiness-2 |
| title | 備檢查就緒 |
| description | 備組織受監管檢查：對機構特定焦點區（FDA, EMA, MHRA）評備度。含警告信 與 483 主題析、模擬檢查協、文件包備、檢查事務、應對模板。 監管檢查已宣或預期、定期自評、上檢後已施新系、或重大審計發現或致監管注時用之。 |
| author | pjt222 |
| author_url | https://github.com/pjt222/agent-almanac/tree/main/i18n/wenyan/skills/prepare-inspection-readiness |
| license | MIT |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | general |
| practice | life-sciences |
| language | zh |
備檢查就緒
評並進組織受監管檢查之備度，含文件、人員備、事務、應對謀。
用時
- 監管檢查已宣或預期
- 定期檢查就緒自評
- 上檢以來已施新系或新程
- 業界趨（警告信、483）示新焦點區
- 重大審計發現或致監管注
入
- 必要：檢查機構（FDA、EMA、MHRA、或他）
- 必要：預期檢查範（數據完整、CSV、GMP、GLP、GCP）
- 必要：合規架構與系庫
- 可選：往檢報與觀察
- 可選：近業界警告信與 483 主題
- 可選：開放 CAPA 與審計發現
法
第一步：析機構特定焦點區
研檢查機構當前優先：
# Inspection Focus Area Analysis
## Document ID: IFA-[SITE]-[YYYY]-[NNN]
### FDA Current Focus Areas
| Focus Area | Regulatory Basis | Recent 483 Trends | Risk to This Site |
|-----------|-----------------|-------------------|-------------------|
| Data integrity | 21 CFR Part 11, CGMP | #1 cited observation in drug 483s since 2016 | [H/M/L] |
| Audit trail | 21 CFR 11.10(e) | Disabled/incomplete audit trails | [H/M/L] |
| Electronic signatures | 21 CFR 11.50-11.300 | Missing manifestation, shared accounts | [H/M/L] |
| Computer system validation | GAMP 5, FDA guidance | Inadequate validation of Category 4/5 systems | [H/M/L] |
| Change control | ICH Q10 | Undocumented or retrospective changes | [H/M/L] |
| Laboratory controls | 21 CFR 211.160-211.176 | OOS investigation, test repetition | [H/M/L] |
### EMA/MHRA-Specific Considerations
| Area | EU Annex 11 Reference | Focus | Risk to This Site |
|------|----------------------|-------|-------------------|
| Computerized system validation | §4, §5 | Risk-based validation, supplier assessment | [H/M/L] |
| Operational phase | §6-§13 | Security, audit trail, backup, business continuity | [H/M/L] |
| Cloud and outsourced systems | §3.4 | Service level agreements, data sovereignty | [H/M/L] |
| Data governance | MHRA DI guidance | ALCOA+, culture of integrity | [H/M/L] |
得：附險評之檢查焦點區析，限於檢機構。
敗則：若近 483/警告信數不可得，諮 FDA 警告信庫、EMA 檢報、業界刊以得最近趨。
第二步：行就緒自評
對各焦點區評廠：
# Inspection Readiness Assessment
## Document ID: IRA-[SITE]-[YYYY]-[NNN]
### Readiness Scoring
| Focus Area | Weight | Current State | Score (1-5) | Gap | Remediation Priority |
|-----------|--------|--------------|-------------|-----|---------------------|
| Data integrity controls | High | [Description of current state] | [1-5] | [Gap description] | [Critical/High/Medium/Low] |
| Validation documentation | High | [Description] | [1-5] | [Gap] | [Priority] |
| Audit trail compliance | High | [Description] | [1-5] | [Gap] | [Priority] |
| Electronic signatures | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| Change control | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| Training records | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| SOPs (current, approved) | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| CAPA management | Medium | [Description] | [1-5] | [Gap] | [Priority] |
| Vendor qualification | Low | [Description] | [1-5] | [Gap] | [Priority] |
| Periodic review | Low | [Description] | [1-5] | [Gap] | [Priority] |
Score: 1 = Critical gaps, 5 = Fully compliant
Overall readiness score: [Sum / Max] = [X]%
| Gap ID | Description | Owner | Action | Deadline | Status |
|--------|------------|-------|--------|----------|--------|
| GAP-001 | [Gap] | [Name] | [Remediation action] | [Date] | [Open/In Progress/Closed] |
