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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。
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インストールを決める前に、SKILL.md と SkillsMP に表示されている付属ファイルをお読みください。
Codex または Claude でインストール この Prompt をコピーして Codex、Claude、または他のアシスタントに貼り付けると、Skill ページを確認してインストールできます。
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npx skills add https://github.com/ThomasMoreAI/legal-skills-open --skill prepare-inspection-readiness-2コマンドは1行のまま表示されます。コピー前に横へスクロールして全体を確認してください。
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Use when retrieving arbitration institutional rules (ICC, LCIA, SCC, SIAC, HKIAC, VIAC, МКАС/МАК при ТПП України, UNCITRAL) — fetching current version, verifying redaction applicable to the date of arbitration agreement, constructing URLs for official rule texts
Use when choosing the Polish legal regime for letters, requests, applications, complaints, petitions, public-information requests, KPA filings, PPSA complaints, RODO access requests, registry extracts, court-file access, tax/ZUS/cudzoziemcy/USC procedures, or professional lawyer letters. Prevents mixing UDIP, KPA, PPSA, RODO, registry, special-procedure, and advocate/radca letter regimes.
Use when preparing applications for recognition and enforcement of foreign arbitral awards in Poland, applications for setting aside arbitral awards under KPC art. 1205–1211, or opposing such applications — mapping Article V of the 1958 New York Convention to art. 1214–1215 of the Polish KPC, identifying grounds for refusal, structuring public policy arguments
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SKILL.md を表示中
| 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 |
評並進組織受監管檢查之備度，含文件、人員備、事務、應對謀。
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。
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] |
得：量化之就緒評，附分優之補救動。 敗則：若總就緒於 70% 下，考請延檢（若許）並施緊急補救。
理文件為檢查就緒之包：
# Inspection Document Bundles
### Bundle 1: Validation Pack (per system)
- [ ] Current validation status summary (one-page per system)
- [ ] User Requirements Specification (URS)
- [ ] Risk Assessment
- [ ] Validation Plan
- [ ] IQ Protocol and Report
- [ ] OQ Protocol and Report
- [ ] PQ Protocol and Report (if applicable)
- [ ] Traceability Matrix
- [ ] Validation Summary Report
- [ ] Periodic review records
- [ ] Change control history since last validation
### Bundle 2: Data Integrity Evidence
- [ ] Data integrity policy and programme
- [ ] ALCOA+ assessment results
- [ ] Audit trail review records (last 12 months)
- [ ] Data integrity monitoring metrics and trends
- [ ] Data integrity training records
### Bundle 3: Operational Evidence
- [ ] Current SOPs (master list with effective dates)
- [ ] Training matrix (all GxP personnel)
- [ ] Change control log (last 24 months)
- [ ] Deviation/incident log (last 24 months)
- [ ] CAPA log with closure status
- [ ] Internal audit reports and CAPA follow-up
### Bundle 4: System Configuration Evidence
- [ ] User access list (current active users with roles)
- [ ] System configuration documentation
- [ ] Backup and recovery test records
- [ ] Security patch log
- [ ] Business continuity/disaster recovery plan
得：諸包皆備、索、可於檢者請後 30 分內取。 敗則：若文缺或不全，立缺列、分優補救、記謀。檢者察雜亂。
# Mock Inspection Protocol
## Document ID: MIP-[SITE]-[YYYY]-[NNN]
### Scope
- **Focus areas:** [Top 3-5 risk areas from readiness assessment]
- **Systems in scope:** [Systems likely to be inspected]
- **Duration:** [1-2 days]
### Participants
| Role | Name | Mock Inspection Role |
|------|------|---------------------|
| Mock inspector | [Experienced QA or external consultant] | Ask questions, request documents |
| System owner(s) | [Names] | Respond to questions, demonstrate systems |
| QA | [Name] | Observe, note findings |
| Back room coordinator | [Name] | Locate and provide documents |
### Mock Inspection Scenarios
| Scenario | Focus | Inspector Might Ask |
|----------|-------|-------------------|
| 1: Show me the audit trail | Data integrity | "Show me the audit trail for batch record BR-2025-1234" |
| 2: Walk me through a change | Change control | "Show me the change control for the last system upgrade" |
| 3: Show training records | Training | "Show me the training records for user [Name] on system [X]" |
| 4: Explain your validation | CSV | "Walk me through how you validated this system" |
| 5: Show a deviation | CAPA | "Show me your last critical deviation and its CAPA" |
| 6: User access review | Access control | "Show me how you manage user access when people leave" |
### Post-Mock Assessment
| Scenario | Outcome | Findings | Actions |
|----------|---------|----------|---------|
| [#] | [Satisfactory/Needs Work] | [Description] | [Remediation if needed] |
得：模擬檢查於實檢前揭問題。 敗則：若模擬檢揭關鍵缺，當實檢觀察之急視之。
# Inspection Logistics Plan
### Room Setup
| Room | Purpose | Equipment | Assigned To |
|------|---------|-----------|-------------|
| Front room | Inspector workspace | Table, chairs, network access, printer | Facility manager |
| Back room | Document retrieval and strategy | Copier, network access, phone | QA team |
| Demo room | System demonstrations | Workstation with system access | IT support |
### Roles During Inspection
| Role | Person | Responsibilities |
|------|--------|-----------------|
| Inspection coordinator | [Name] | Single point of contact with inspector, schedule management |
| Subject matter experts | [Names] | Answer technical questions in their domain |
| Back room lead | [Name] | Coordinate document retrieval, track requests |
| Scribe | [Name] | Document all questions, requests, and responses |
| Executive sponsor | [Name] | Available for escalation, opening/closing meetings |
### Communication Protocol
- All document requests flow through the back room lead
- No documents provided without QA review
- Questions requiring research get a "we will get back to you" response (track and follow up)
- Daily debrief with inspection team after each day
得：事務謀確專業、有序之檢查應對。 敗則：若關鍵人於檢日不可得，識並簡介替代。
# Inspection Response Templates
### Template 1: 483 Observation Response
[Date]
[FDA District Office Address]
Re: FDA Form 483 Observations — [Inspection Dates] — [Facility Name]
Dear [Inspector Name],
We appreciate the opportunity to address the observations identified during the inspection of [facility] on [dates].
**Observation [N]:** [Quote the exact observation text]
**Response:**
- **Root Cause:** [Brief root cause description]
- **Immediate Corrective Action:** [What was done immediately]
- Completed: [Date]
- **Long-term Corrective Action:** [Systemic fix]
- Target completion: [Date]
- **Preventive Action:** [How recurrence will be prevented]
- Target completion: [Date]
- **Effectiveness Verification:** [How effectiveness will be measured]
- Target verification date: [Date]
### Template 2: Immediate Correction During Inspection
When an inspector identifies an issue that can be corrected immediately:
1. Acknowledge the observation
2. Implement the correction (if feasible)
3. Document the correction with before/after evidence
4. Inform the inspector that the correction has been made
5. Include in the formal response as "corrected during inspection"
得：應對模板使對檢查觀察之速、結構化回。 敗則：若應對模板通用而不對特定觀察，依特定證與時程定制各應對。
design-compliance-architecture — 檢者欲見之基文conduct-gxp-audit — 內審當仿檢方法monitor-data-integrity — 數據完整為 FDA 檢之首焦investigate-capa-root-cause — CAPA 必檢前徹查qualify-vendor — 廠商資質檢時常請