Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical/major/minor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.
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Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence collection, finding classification (critical/major/minor), CAPA generation, closing meetings, report writing, and follow-up verification. Use for scheduled internal audits, supplier qualification audits, pre-inspection readiness assessments, for-cause audits triggered by deviations or data integrity concerns, or periodic compliance posture reviews of validated systems.
Plan + execute GxP audit of computerized systems, data integrity practices, or regulated procs.
Use When
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's compliance posture
In
Required: Audit scope (system, proc, or site to audit)
Required: Applicable regs (21 CFR Part 11, EU Annex 11, GMP, GLP, GCP)
Required: Prev audit reports + open CAPA items
Optional: System valid. docs (URS, VP, IQ/OQ/PQ, traceability matrix)
Optional: SOPs, training records, change control logs
Optional: Specific risk areas / concerns triggering audit
Do
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 |
| Role | Name | Responsibility |
|------|------|---------------|
| Lead Auditor | [Name] | Plan, execute, report |
| Subject Matter Expert | [Name] | Technical assessment |
| Auditee Representative | [Name] | Facilitate access and information |
### 5. Audit Team
→ Audit plan approved by QA mgmt + communicated to auditee ≥ 2 weeks before audit.
If err: Reschedule if auditee can't provide req'd docs or personnel.
Change control records complete (req, assessment, approval, valid.)
Incident/deviation reports handled per SOP
Periodic review conducted on schedule
3c. Data Integrity Assessment
Audit trail enabled + not user-modifiable
Electronic sigs meet reg req's
Backup + recovery docs'd + tested
Access controls enforce role-based perms
Data: attributable, legible, contemporaneous, original, accurate (ALCOA+)
3d. System Configuration Review
Prod config matches validated state
User accounts reviewed — no shared accounts, inactive disabled
System clocks sync'd + accurate
Security patches applied per approved change control
→ Evidence collected as screenshots, doc copies, interview notes w/ timestamps.
If err: Can't verify → record "unable to verify" as observation + reason.
Step 4: Classify Findings
Classify each finding by severity:
Classification
Definition
Response Required
Critical
Direct impact on product quality, patient safety, or data integrity. Systematic failure of a key control.
Immediate containment + CAPA within 15 business days
Major
Significant departure from GxP requirements. Potential to impact data integrity if uncorrected.
CAPA within 30 business days
Minor
Isolated deviation from procedure. No direct impact on data integrity or product quality.
Correction within 60 business days
Observation
Opportunity for improvement. Not a regulatory requirement.
Optional — tracked for trend analysis
Doc 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]
→ Every finding has classification, evidence, reg ref.
If err: Classification disputed → escalate to audit program manager for adjudication.
Step 5: Conduct Closing Meeting
Agenda:
Present findings summary (no new findings should be raised)
# 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 | | | |
→ Report issued within 15 business days of closing meeting.
If err: Delayed beyond 15 days → notify stakeholders + doc reason.
Step 7: Track CAPA + Verify Effectiveness
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 |
→ CAPAs assigned, tracked, effectiveness verified per defined timeline.
If err: Unresolved CAPAs escalate to QA mgmt + flag in next audit cycle.
Check
Audit plan approved + communicated pre-audit
Opening + closing meetings doc'd w/ attendance
Evidence collected w/ timestamps + source refs
Every finding has classification, evidence, reg ref
Audit report issued within 15 business days
CAPAs assigned w/ due dates for all critical + major findings
Prev audit CAPAs verified for closure effectiveness
