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Audit Processes

This section provides comprehensive guidance for audit preparation, management, and execution across multiple regulatory frameworks including ISO 13485, FDA 21 CFR Part 11, GDPR, and SOC 2.

Available Audit Guides​

Framework-Specific Audit Preparation​

General Audit Management​

  • Audit planning and scoping
  • Evidence collection and organization
  • Auditor management and coordination
  • Post-audit remediation and follow-up

Audit Lifecycle Management​

1. Pre-Audit Phase​

  • Audit Planning: Scope definition, timeline establishment, resource allocation
  • Documentation Preparation: Policy review, procedure updates, evidence compilation
  • System Readiness: Access provisioning, data preparation, stakeholder briefing
  • Risk Assessment: Identify potential audit findings and prepare responses

2. Audit Execution Phase​

  • Opening Meeting: Audit scope confirmation, logistics coordination
  • Evidence Presentation: Systematic evidence delivery and explanation
  • Control Testing: Support auditor testing activities and provide clarifications
  • Issue Resolution: Address findings and questions in real-time when possible

3. Post-Audit Phase​

  • Findings Review: Analyze audit findings and recommendations
  • Remediation Planning: Develop corrective action plans for identified gaps
  • Implementation Tracking: Monitor remediation progress and effectiveness
  • Continuous Improvement: Update processes based on audit insights

Framework-Specific Audit Requirements​

ISO 13485 Medical Device Audits​

  • Internal Audit Program: Systematic internal audit procedures
  • Management Review: Executive oversight and decision-making processes
  • Corrective and Preventive Actions (CAPA): Non-conformance management
  • Design Control Audits: Design and development process verification

FDA 21 CFR Part 11 Audits​

  • Computer System Validation: CSV documentation and evidence
  • Electronic Signature Compliance: E-signature system validation
  • Audit Trail Integrity: Complete and tamper-evident audit records
  • Data Integrity: ALCOA+ principles implementation

GDPR Compliance Audits​

  • Data Processing Activities: Article 30 record maintenance
  • Data Subject Rights: Rights fulfillment procedures and evidence
  • Privacy Impact Assessments: DPIA documentation and outcomes
  • Breach Management: Incident response and notification procedures

SOC 2 Security Audits​

  • Trust Service Criteria: CC, A, PI, C controls implementation
  • Control Design: Control design adequacy and documentation
  • Operating Effectiveness: Control operation over the audit period
  • Complementary User Entity Controls (CUECs): Customer responsibility documentation

Audit Evidence Management​

Evidence Collection Framework​

interface AuditEvidence {
  id: string;
  type: 'policy' | 'procedure' | 'record' | 'screenshot' | 'report';
  framework: string;
  control: string;
  description: string;
  dateCreated: Date;
  retentionPeriod: string;
  location: string;
  custodian: string;
  relatedEvidence?: string[];
}

class AuditEvidenceManager {
  async collectEvidence(auditScope: AuditScope): Promise<EvidencePackage> {
    const evidence = [];

    // Collect policy documentation
    const policies = await this.collectPolicies(auditScope.frameworks);
    evidence.push(...policies);

    // Collect operational records
    const records = await this.collectOperationalRecords(auditScope.period);
    evidence.push(...records);

    // Collect system evidence
    const systemEvidence = await this.collectSystemEvidence(auditScope.systems);
    evidence.push(...systemEvidence);

    return this.packageEvidence(evidence);
  }
}

Evidence Organization Structure​

audit-evidence/
├── policies/
│   ├── information-security-policy.pdf
│   ├── privacy-policy.pdf
│   └── quality-manual.pdf
├── procedures/
│   ├── access-control-procedures.pdf
│   ├── incident-response-procedures.pdf
│   └── change-management-procedures.pdf
├── records/
│   ├── access-reviews/
│   ├── security-incidents/
│   └── training-records/
├── system-evidence/
│   ├── configuration-screenshots/
│   ├── log-samples/
│   └── monitoring-reports/
└── index/
    ├── evidence-index.xlsx
    └── control-mapping.xlsx

Automated Audit Support​

Evidence Collection Automation​

#!/bin/bash
# audit-evidence-collector.sh

echo "Collecting audit evidence for period: $1 to $2"

# Collect access logs
sc audit collect-logs --type=access --from=$1 --to=$2 --output=evidence/access-logs/

# Collect security events
sc audit collect-logs --type=security --from=$1 --to=$2 --output=evidence/security-events/

# Generate compliance reports
sc compliance report --framework=soc2 --period=$1-$2 --output=evidence/compliance-reports/

# Collect system configurations
sc audit collect-configs --systems=all --output=evidence/system-configs/

# Generate evidence index
sc audit generate-index --evidence-dir=evidence/ --output=evidence/evidence-index.xlsx

Real-Time Audit Dashboard​

class AuditDashboard {
  async generateAuditReadinessScore(): Promise<AuditReadiness> {
    const frameworks = ['iso13485', 'soc2', 'gdpr'];
    const readiness = {};

    for (const framework of frameworks) {
      const controls = await this.getFrameworkControls(framework);
      const evidenceCompleteness =
        await this.assessEvidenceCompleteness(controls);
      const controlEffectiveness =
        await this.assessControlEffectiveness(controls);

      readiness[framework] = {
        overallScore: (evidenceCompleteness + controlEffectiveness) / 2,
        evidenceCompleteness,
        controlEffectiveness,
        gaps: await this.identifyGaps(framework),
        recommendations: await this.generateRecommendations(framework),
      };
    }

    return readiness;
  }
}

Auditor Management​

Auditor Coordination​

  • Communication Protocols: Establish clear communication channels
  • Access Management: Provide secure, auditable access to systems and data
  • Schedule Management: Coordinate interviews, testing, and review sessions
  • Question Management: Track and respond to auditor questions systematically

Stakeholder Preparation​

## Audit Interview Preparation Checklist

### For Management

- [ ] Review organizational chart and reporting relationships
- [ ] Prepare overview of compliance program and governance
- [ ] Review key policies and their approval/update processes
- [ ] Prepare examples of management oversight activities

### For Technical Staff

- [ ] Review system architecture and security controls
- [ ] Prepare technical documentation and configuration details
- [ ] Review incident response procedures and examples
- [ ] Prepare change management process documentation

### For Process Owners

- [ ] Review process documentation and flowcharts
- [ ] Prepare examples of process execution and monitoring
- [ ] Review training records and competency assessments
- [ ] Prepare metrics and performance indicators

Audit Findings Management​

Finding Classification​

  • Critical: Significant control deficiencies requiring immediate attention
  • High: Important gaps that should be addressed within 30 days
  • Medium: Moderate issues that should be addressed within 90 days
  • Low: Minor improvements that should be addressed within 180 days

Remediation Tracking​

interface AuditFinding {
  id: string;
  severity: 'critical' | 'high' | 'medium' | 'low';
  framework: string;
  control: string;
  description: string;
  recommendation: string;
  managementResponse: string;
  remediationPlan: {
    actions: string[];
    timeline: string;
    owner: string;
    resources: string[];
  };
  status: 'open' | 'in-progress' | 'resolved' | 'accepted-risk';
  evidence?: string[];
}

Continuous Audit Preparation​

Ongoing Readiness Activities​

  • Monthly Evidence Reviews: Regular evidence collection and organization
  • Quarterly Control Testing: Internal control effectiveness testing
  • Annual Policy Reviews: Policy and procedure updates and approvals
  • Continuous Monitoring: Real-time compliance monitoring and alerting

Audit Readiness Metrics​

  • Evidence completeness percentage
  • Control testing pass rates
  • Policy currency (days since last review)
  • Training completion rates
  • Incident response times

Audit processes ensure organizations are prepared for regulatory audits and can demonstrate compliance through comprehensive evidence collection and systematic audit management.