# Prepare Inspection Readiness

> Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (FDA, EMA, MHRA). Covers warning letter and 483 theme analysis, mock inspection protocols, document bundle preparation, inspection logistics, and response template creation. Use when a regulatory inspection has been announced or is anticipated, when a periodic self-assessment is due, when new systems have been implemented since the last inspection, or after a significant audit finding that may attract regulatory attention.

- Skill: `pjt222/prepare-inspection-readiness-9` (Agent Skill)
- Install (CLI): `npx skillmds@latest add pjt222/prepare-inspection-readiness-9`
- Raw SKILL.md: https://api.skillmd.com/api/skills/pjt222/prepare-inspection-readiness-9/raw
- Safety review: pending (external: skill-scanner PASS, skillspector PASS)
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: Security
- License: MIT
- Author: pjt222 (https://skillmd.com/u/pjt222)
- Updated: 2026-09-21
- Page: https://skillmd.com/skills/pjt222/prepare-inspection-readiness-9

---


# 備檢

評增組為規檢之備、含文、人備、後勤、應計。

## 用

- 規檢已告或預→用
- 期察檢備→用
- 末檢以來新系/程已實→用
- 業勢（警函、483）顯新聚→用
- 大審發恐引規注後→用

## 入

- **必**：檢機（FDA、EMA、MHRA 或他）
- **必**：預檢範（資整、CSV、GMP、GLP、GCP）
- **必**：循架與系錄
- **可**：前檢報與見
- **可**：近業警函與 483 題
- **可**：開 CAPA 與審發

## 行

### 一：析機特聚

研檢機今先：

```markdown
# 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：檢機特之檢聚險評析。
敗：近 483/警函資未得→詢 FDA 警函庫、EMA 檢報或業刊為今勢。

### 二：行備自察

各聚評址：

```markdown
# 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] |
```

得：量化備察含序補行。
敗：總備 <70%→計求檢延（若許）、行急補。

### 三：備文包

組文為檢備包：

```markdown
# 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：諸包成、索、可於檢者求 30 分內取。
敗：文缺或不全→立缺列、序補、記計。檢者察亂。

### 四：設假檢則

```markdown
# 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：假檢於實檢前顯事。
敗：假檢顯要缺→與實檢見同急。

### 五：計檢後勤

```markdown
# 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：後勤計確專、組之檢應。
敗：要員不在檢日→識備員告之。

### 六：立應模

```markdown
# 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：應模供速構應檢見。
敗：模通而不對特見→各應含特據與時。

## 驗

- [ ] 機特聚已析含險評
- [ ] 備自察畢含量分
- [ ] 諸缺補計含主與期
- [ ] 諸範系文包成索
- [ ] 假檢行含記發與隨
- [ ] 檢後勤計定室、職、訊則
- [ ] 應模備於常見型
- [ ] 諸要補項於檢日前閉

## 忌

- **末刻備**：檢備為續程、非臨陣磨。慌組產亂應
- **隱事**：檢者為歷專察隱。明含補計常優於試隱
- **過獻信**：答所問。獻未求信開新詢線
- **未訓員**：未練應檢者問之專員劣行。假檢為要練
- **忽後室**：後室（文取與策協）同重於前室。劣文取生亂象

## 參

- `design-compliance-architecture` — 檢者欲見之基檔
- `conduct-gxp-audit` — 內審當擬檢法
- `monitor-data-integrity` — 資整為 FDA 檢首聚
- `investigate-capa-root-cause` — CAPA 必檢前徹查
- `qualify-vendor` — 商資檢中常求