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.
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 and execute a GxP audit of computerized systems, data integrity practices, or regulated processes.
When to Use
Scheduled internal audit of a validated computerized system
Supplier/vendor qualification audit for GxP-relevant software
Pre-inspection readiness assessment before a regulatory audit
For-cause audit triggered by a deviation, complaint, or data integrity concern
Periodic review of a validated system's 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 and 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 the audit
Procedure
Step 1: Develop the 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
Got: Audit plan approved by quality management and communicated to auditee at least 2 weeks before the audit.
If fail: Reschedule if auditee cannot provide required documentation or personnel.
Step 2: Conduct Opening Meeting
Agenda:
Introduce audit team and roles
Confirm scope, schedule, and logistics
Explain finding classification system (critical/major/minor)
Confirm confidentiality agreements
Identify auditee escorts and document custodians
Address questions
Got: Opening meeting documented with attendance record.
If fail: If key personnel are unavailable, reschedule affected audit activities.
Step 3: Collect and Review Evidence
Review documentation and records against audit criteria:
3a. Validation Documentation Review
URS exists and is approved
Validation plan matches system category and risk
IQ/OQ/PQ protocols executed with results documented
Traceability matrix links requirements to test results
Deviations documented and resolved
Validation summary report approved
3b. Operational Controls Review
SOPs current and approved
Training records demonstrate competence for all users
Change control records complete (request, assessment, approval, verification)
Backup and recovery procedures documented and 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 and 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 an observation and note the 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
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, and regulatory reference.
If fail: If classification is disputed, escalate to the audit program manager for adjudication.
Step 5: Conduct Closing Meeting
Agenda:
Present findings summary (no new findings should be raised)
Review finding classifications
Discuss preliminary CAPA expectations and timelines
Confirm next steps and report timeline
Acknowledge auditee cooperation
Got: Closing meeting documented with attendance. Auditee acknowledges findings (acknowledgement ≠ agreement).
If fail: If auditee disputes a finding, document the disagreement and 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 the closing meeting.
If fail: If delayed beyond 15 days, notify stakeholders and document the reason.
Step 7: Track CAPA and Verify Effectiveness
For each finding requiring a 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, and effectiveness verified per defined timeline.
If fail: Unresolved CAPAs escalate to QA management and are flagged in the next audit cycle.
Validation
Audit plan approved and communicated before audit
Opening and closing meetings documented with attendance
Evidence collected with timestamps and source references
Every finding has classification, evidence, and 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 the audit scope during execution without formal agreement leads to incomplete coverage and 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 a CAPA without verifying the fix actually works is a recurring regulatory citation.
Related Skills
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 and report writing
