Conduct Gxp Audit

Conduct GxP Audit

Plan and execute GxP audit of computerized systems, data integrity practices, or regulated processes.

When Use

• Scheduled internal audit of validated computerized system
• Supplier/vendor qualification audit for GxP-relevant software
• Pre-inspection readiness assessment before regulatory audit
• For-cause audit triggered by deviation, complaint, or data integrity concern
• Periodic review of validated system compliance posture

Inputs

• Required: Audit scope (system, process, or site to audit)
• Required: Applicable regulations (21 CFR Part 11, EU Annex 11, GMP, GLP, GCP)
• Required: Previous audit reports, open CAPA items
• Optional: System validation documentation (URS, VP, IQ/OQ/PQ, traceability matrix)
• Optional: SOPs, training records, change control logs
• Optional: Specific risk areas or concerns triggering audit

Steps

Step 1: Develop Audit Plan

# Audit Plan
## Document ID: AP-[SYS]-[YYYY]-[NNN]

### 1. Objective
[State the purpose: scheduled, for-cause, supplier qualification, pre-inspection]

### 2. Scope
- **System/Process**: [Name and version]
- **Regulations**: [21 CFR Part 11, EU Annex 11, ICH Q7, etc.]
- **Period**: [Date range of records under review]
- **Exclusions**: [Any areas explicitly out of scope]

### 3. Audit Criteria
| Area | Regulatory Reference | Key Requirements |
|------|---------------------|------------------|
| Electronic records | 21 CFR 11.10 | Controls for closed systems |
| Audit trail | 21 CFR 11.10(e) | Secure, computer-generated, time-stamped |
| Electronic signatures | 21 CFR 11.50 | Manifestation, legally binding |
| Access controls | EU Annex 11, §12 | Role-based, documented |
| Data integrity | MHRA guidance | ALCOA+ principles |
| Change control | ICH Q10 | Documented, assessed, approved |

### 4. Schedule
| Date | Time | Activity | Participants |
|------|------|----------|-------------|
| Day 1 AM | 09:00 | Opening meeting | All |
| Day 1 AM | 10:00 | Document review | Auditor + QA |
| Day 1 PM | 13:00 | System walkthrough | Auditor + IT + System Owner |
| Day 2 AM | 09:00 | Interviews + evidence collection | Auditor + Users |
| Day 2 PM | 14:00 | Finding consolidation | Auditor |
| Day 2 PM | 16:00 | Closing meeting | All |

### 5. Audit Team
| Role | Name | Responsibility |
|------|------|---------------|
| Lead Auditor | [Name] | Plan, execute, report |
| Subject Matter Expert | [Name] | Technical assessment |
| Auditee Representative | [Name] | Facilitate access and information |

Got: Audit plan approved by quality management, communicated to auditee at least 2 weeks before audit. If fail: Reschedule if auditee cannot provide required documentation or personnel.

Step 2: Conduct Opening Meeting

Agenda:

1. Introduce audit team, roles
2. Confirm scope, schedule, logistics
3. Explain finding classification system (critical/major/minor)
4. Confirm confidentiality agreements
5. Identify auditee escorts, document custodians
6. Address questions

Got: Opening meeting documented with attendance record. If fail: Key personnel unavailable? Reschedule affected audit activities.

Step 3: Collect and Review Evidence

Review documentation, records against audit criteria:

3a. Validation Documentation Review

• URS exists, approved
• Validation plan matches system category, risk
• IQ/OQ/PQ protocols executed with results documented
• Traceability matrix links requirements to test results
• Deviations documented, resolved
• Validation summary report approved

3b. Operational Controls Review

• SOPs current, approved
• Training records demonstrate competence for all users
• Change control records complete (request, assessment, approval, verification)
• Incident/deviation reports handled per SOP
• Periodic review conducted on schedule

3c. Data Integrity Assessment

• Audit trail enabled, not modifiable by users
• Electronic signatures meet regulatory requirements
• Backup and recovery procedures documented, tested
• Access controls enforce role-based permissions
• Data is attributable, legible, contemporaneous, original, accurate (ALCOA+)

3d. System Configuration Review

• Production configuration matches validated state
• User accounts reviewed — no shared accounts, inactive accounts disabled
• System clocks synchronized, accurate
• Security patches applied per approved change control

Got: Evidence collected as screenshots, document copies, interview notes with timestamps. If fail: Record "unable to verify" as observation, note reason.

Step 4: Classify Findings

Classify each finding by severity:

Document each finding:

## Finding F-[NNN]
**Classification:** [Critical / Major / Minor / Observation]
**Area:** [Audit trail / Access control / Change control / etc.]
**Reference:** [Regulatory clause, e.g., 21 CFR 11.10(e)]

**Observation:**
[Objective description of what was found]

**Evidence:**
[Document ID, screenshot reference, interview notes]

**Regulatory Expectation:**
[What the regulation requires]

**Risk:**
[Impact on data integrity, product quality, or patient safety]

Got: Every finding has classification, evidence, regulatory reference. If fail: Classification disputed? Escalate to audit program manager for adjudication.

Step 5: Conduct Closing Meeting

Agenda:

1. Present findings summary (no new findings should be raised)
2. Review finding classifications
3. Discuss preliminary CAPA expectations, timelines
4. Confirm next steps, report timeline
5. Acknowledge auditee cooperation

Got: Closing meeting documented with attendance. Auditee acknowledges findings (acknowledgement ≠ agreement). If fail: Auditee disputes finding? Document disagreement, escalate per SOP.

Step 6: Write Audit Report

# Audit Report
## Document ID: AR-[SYS]-[YYYY]-[NNN]

### 1. Executive Summary
An audit of [System/Process] was conducted on [dates] against [regulations].
[N] findings were identified: [n] critical, [n] major, [n] minor, [n] observations.

### 2. Scope and Methodology
[Summarize audit plan scope, criteria, and methods used]

### 3. Findings Summary
| Finding ID | Classification | Area | Brief Description |
|-----------|---------------|------|-------------------|
| F-001 | Major | Audit trail | Audit trail disabled for batch record module |
| F-002 | Minor | Training | Two users missing annual GxP training |
| F-003 | Observation | Documentation | SOP formatting inconsistencies |

### 4. Detailed Findings
[Include full finding details from Step 4 for each finding]

### 5. Positive Observations
[Document areas of good practice observed during the audit]

### 6. Conclusion
The overall compliance status is assessed as [Satisfactory / Needs Improvement / Unsatisfactory].

### 7. Distribution
| Recipient | Role |
|-----------|------|
| [Name] | System Owner |
| [Name] | QA Director |
| [Name] | IT Manager |

### Approval
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Lead Auditor | | | |
| QA Director | | | |

Got: Report issued within 15 business days of closing meeting. If fail: Delayed beyond 15 days? Notify stakeholders, document reason.

Step 7: Track CAPA and Verify Effectiveness

For each finding requiring CAPA:

## CAPA Tracking
| Finding ID | CAPA ID | Root Cause | Corrective Action | Due Date | Status | Effectiveness Check |
|-----------|---------|------------|-------------------|----------|--------|-------------------|
| F-001 | CAPA-2025-042 | Configuration oversight during upgrade | Enable audit trail, verify all modules | 2025-04-15 | Open | Scheduled 2025-07-15 |
| F-002 | CAPA-2025-043 | Training matrix not updated | Complete training, update tracking | 2025-05-01 | Open | Scheduled 2025-08-01 |

Got: CAPAs assigned, tracked, effectiveness verified per defined timeline. If fail: Unresolved CAPAs escalate to QA management, flagged in next audit cycle.

Checks

• Audit plan approved, communicated before audit
• Opening and closing meetings documented with attendance
• Evidence collected with timestamps, source references
• Every finding has classification, evidence, regulatory reference
• Audit report issued within 15 business days
• CAPAs assigned with due dates for all critical and major findings
• Previous audit CAPAs verified for closure effectiveness

Pitfalls

• Scope creep: Expanding audit scope during execution without formal agreement leads to incomplete coverage, disputes.
• Opinion-based findings: Findings must reference specific regulatory requirements, not personal preferences.
• Adversarial tone: Audits are collaborative quality improvement exercises, not interrogations.
• Ignoring positives: Reporting only findings without acknowledging good practices undermines trust.
• No effectiveness check: Closing CAPA without verifying fix actually works is recurring regulatory citation.

See Also

• perform-csv-assessment — full CSV lifecycle assessment (URS through validation summary)
• setup-gxp-r-project — project structure for validated R environments
• implement-audit-trail — audit trail implementation for electronic records
• write-validation-documentation — IQ/OQ/PQ protocol, report writing
• security-audit-codebase — security-focused code audit (complementary perspective)