From agent-almanac
Assesses organisational readiness for regulatory inspections from FDA, EMA, MHRA, covering warning letter analysis, mock inspection protocols, document bundling, and response templates.
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/agent-almanac:prepare-inspection-readinessThis skill is limited to the following tools:
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Assess and improve organisational readiness for regulatory inspection, covering documentation, personnel preparation, logistics, and response planning.
Assess and improve organisational readiness for regulatory inspection, covering documentation, personnel preparation, logistics, and response planning.
Research the inspecting authority's current priorities:
# 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] |
Expected: A risk-rated analysis of inspection focus areas specific to the inspecting authority. On failure: If recent 483/warning letter data is unavailable, consult the FDA warning letter database, EMA inspection reports, or industry publications for the most current trends.
Evaluate the site against each focus area:
# 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] |
Expected: A quantified readiness assessment with prioritised remediation actions. On failure: If overall readiness is below 70%, consider requesting an inspection delay (if permitted) and implementing emergency remediation.
Organise documentation into inspection-ready packages:
# 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
Expected: All bundles are assembled, indexed, and accessible within 30 minutes of an inspector's request. On failure: If documents are missing or incomplete, create a gap list, prioritise remediation, and document the plan. Inspectors notice disorganisation.
# 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] |
Expected: Mock inspection reveals issues before the real inspection does. On failure: If mock inspection reveals critical gaps, treat them as critical findings with the same urgency as real inspection observations.
# 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
Expected: Logistics plan ensures a professional, organised response to the inspection. On failure: If key personnel are unavailable on the inspection date, identify and brief alternates.
# 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"
Expected: Response templates enable rapid, structured replies to inspection observations. On failure: If response templates are generic and do not address the specific observation, customise each response with specific evidence and timelines.
design-compliance-architecture — the foundation document inspectors will want to seeconduct-gxp-audit — internal audits should mimic inspection methodologymonitor-data-integrity — data integrity is the top FDA inspection focus areainvestigate-capa-root-cause — CAPAs must be thoroughly investigated before inspectionqualify-vendor — vendor qualifications are frequently requested during inspectionsnpx claudepluginhub pjt222/agent-almanacPlans and executes GxP audits of computerized systems and processes, covering opening meetings, evidence collection, finding classification, CAPA generation, and report writing. Use for scheduled internal audits, supplier qualification, pre-inspection readiness, or for-cause audits.
Activate for: audit, audit preparation, audit pack, internal audit, external audit, regulatory audit, supervisory visit, audit evidence, audit trail, audit readiness, mock audit, audit findings, audit response, audit remediation, audit committee, board audit, annual audit, ISO audit, surveillance audit, certification audit, regulator visit, FCA visit, BSI audit, PCI audit, SOC 2 audit, audit questionnaire, evidence inventory. NOT for: compliance obligation mapping (use official compliance-tracking auto-skill), vendor evaluation (use official /vendor-review), risk register building (use official risk-assessment auto-skill).
Guides preparation for DPA inspections with document checklists, interview prep for personnel, technical demo procedures, on-site logistics, response protocols, and follow-up. Useful for GDPR compliance during audits or investigations.