MCP HubMCP Hub
← Retour aux compétences

prepare-inspection-readiness

pjt222
Mis à jour Yesterday
2 vues
17
2
17
Voir sur GitHub
Métawordai

À propos

Cette compétence aide les organisations à se préparer aux inspections réglementaires en évaluant leur niveau de préparation par rapport aux domaines de contrôle spécifiques des agences comme la FDA, l'EMA et la MHRA. Elle offre des capacités d'analyse des lettres d'avertissement, de création de protocoles d'inspection simulés, de préparation de lots de documents et de génération de modèles de réponses. Utilisez-la lorsqu'une inspection est annoncée, pour des auto-évaluations périodiques, après la mise en œuvre de nouveaux systèmes, ou suite à des conclusions d'audit significatives.

Installation rapide

Claude Code

Recommandé
Principal
npx skills add pjt222/agent-almanac -a claude-code
Commande PluginAlternatif
/plugin add https://github.com/pjt222/agent-almanac
Git CloneAlternatif
git clone https://github.com/pjt222/agent-almanac.git ~/.claude/skills/prepare-inspection-readiness

Copiez et collez cette commande dans Claude Code pour installer cette compétence

Documentation

備檢準備度

評估並提升組織迎檢之準備度，含文件、人員、行政與回應規劃。

適用時機

  • 法規檢查已通報或可預見
  • 屆定期之自我評估
  • 自上次檢查以來實施了新系統或新流程
  • 業界趨勢（警告函、483）顯示新焦點區
  • 重大稽核發現後，恐引法規關注

輸入

  • 必要：執行檢查之機關（FDA、EMA、MHRA 或他）
  • 必要：預期檢查範圍（資料完整性、CSV、GMP、GLP、GCP）
  • 必要：合規架構與系統清冊
  • 選擇性：先前檢查報告與觀察項
  • 選擇性：近期業界警告函與 483 主題
  • 選擇性：未結 CAPA 與稽核發現

步驟

步驟一：分析機關特定之焦點區

研究檢查機關當前之優先順序：

# 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] |

預期： 一份依機關之檢查焦點區之風險評等分析。 失敗時： 若無近期 483／警告函資料，查 FDA 警告函資料庫、EMA 檢查報告或業界刊物以取最新趨勢。

步驟二：執行準備度自評

依各焦點區評估場域：

# 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]%

### Remediation Plan
| Gap ID | Description | Owner | Action | Deadline | Status |
|--------|------------|-------|--------|----------|--------|
| GAP-001 | [Gap] | [Name] | [Remediation action] | [Date] | [Open/In Progress/Closed] |

預期： 一份量化之準備度評估，附排序之修補行動。 失敗時： 若整體準備度低於 70%，考慮申請延期（若准許）並施緊急修補。

步驟三：備齊文件包

將文件組為迎檢可用之套：

# 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

預期： 各包皆已組裝、編索引，並可於檢查官請求之 30 分鐘內取得。 失敗時： 若文件缺漏不齊，作缺項清單、排序修補並記錄計畫。檢查官會察覺凌亂。

步驟四：設計模擬檢查方案

# 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] |

預期： 模擬檢查在實檢之前先揭出問題。 失敗時： 若模擬檢查揭出關鍵缺失，以實檢觀察項之同等急迫性處理。

步驟五：規劃檢查行政事務

# 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

預期： 行政計畫確保對檢查之專業、有序回應。 失敗時： 若關鍵人員於檢查日不在，辨明並簡報替補者。

步驟六：建立回應模板

# 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"

預期： 回應模板使對檢查觀察項之答覆迅速且有結構。 失敗時： 若模板過於通用而未對應具體觀察項，依各觀察項以具體證據與時程客製化。

驗證

  • 已分析機關特定焦點區並評風險
  • 已完成自評並量化分數
  • 已對所有缺口建修補計畫，附負責人與期限
  • 已為所有範圍內系統組裝並索引文件包
  • 已執行模擬檢查並記錄發現與後續
  • 行政計畫已界定房間、角色與溝通協定
  • 已為常見觀察類型備回應模板
  • 所有關鍵修補項已於檢查日前結案

常見陷阱

  • 臨時抱佛腳：迎檢之準備為持續性方案，非考前衝刺。倉促組織產出之回應雜亂不全。
  • 隱瞞問題：檢查官為老練專業，能察隱瞞。透明加清晰修補計畫，永優於試圖隱瞞。
  • 多嘴：只答所問。未經請求而提供之資訊可能開新詢問線。
  • 未訓練人員：未練過回答檢查官之 SME 表現不佳。模擬檢查為必要之練習。
  • 忽視後台：後台（文件取得與策略協調）與前台同等重要。文件取得不力會給人雜亂之印象。

相關技能

  • design-compliance-architecture —— 檢查官想看之基礎文件
  • conduct-gxp-audit —— 內稽應仿檢查方法
  • monitor-data-integrity —— 資料完整性為 FDA 檢查首要焦點
  • investigate-capa-root-cause —— CAPA 須於受檢前徹底調查
  • qualify-vendor —— 受檢時常被要求提供供應商資格

Dépôt GitHub

pjt222/agent-almanac
Chemin: i18n/wenyan-lite/skills/prepare-inspection-readiness
0
agentsagentskillsai-assisted-developmentclaude-codeskillsteams

Compétences associées

content-collections

Méta

Cette compétence propose une configuration éprouvée en production pour Content Collections, un outil axé sur TypeScript qui transforme des fichiers Markdown/MDX en collections de données typées de manière sûre avec une validation Zod. Utilisez-la lors de la création de blogs, de sites de documentation ou d'applications Vite + React riches en contenu pour garantir la sécurité de typage et la validation automatique du contenu. Elle couvre tout, de la configuration du plugin Vite et de la compilation MDX à l'optimisation des déploiements et la validation des schémas.

Voir la compétence

polymarket

Méta

Cette compétence permet aux développeurs de créer des applications avec la plateforme de marchés prédictifs Polymarket, incluant l'intégration d'API pour le trading et les données de marché. Elle fournit également une diffusion de données en temps réel via WebSocket pour surveiller les transactions en direct et l'activité du marché. Utilisez-la pour mettre en œuvre des stratégies de trading ou pour créer des outils traitant les mises à jour de marché en direct.

Voir la compétence

creating-opencode-plugins

Méta

Cette compétence aide les développeurs à créer des plugins OpenCode qui s'interconnectent avec plus de 25 types d'événements tels que les commandes, les fichiers et les opérations LSP. Elle fournit la structure du plugin, les spécifications de l'API événementielle et les modèles d'implémentation pour les modules JavaScript/TypeScript. Utilisez-la lorsque vous avez besoin d'intercepter, de surveiller ou d'étendre le cycle de vie de l'assistant IA OpenCode avec une logique personnalisée pilotée par les événements.

Voir la compétence

sglang

Méta

SGLang est un framework de service LLM haute performance spécialisé dans la génération rapide et structurée pour les workflows JSON, regex et agentiques grâce à son cache de préfixe RadixAttention. Il offre une inférence nettement plus rapide, particulièrement pour les tâches avec des préfixes répétés, ce qui le rend idéal pour les sorties complexes et structurées ainsi que les conversations multi-tours. Choisissez SGLang plutôt que des alternatives comme vLLM lorsque vous avez besoin d'un décodage contraint ou que vous construisez des applications avec un partage étendu de préfixes.

Voir la compétence