Audit Trail Documentation
PROCreate comprehensive audit trail policies and documentation meeting GDPR, HIPAA, SOX, and FDA 21 CFR Part 11 compliance requirements.
Example Usage
“Create an audit trail policy for our healthcare SaaS platform MedRecord Pro. We need HIPAA and FDA 21 CFR Part 11 compliance for electronic health records. Document requirements for user activity logging, data access tracking, change history, and tamper-proof storage. Include log format specifications, retention requirements (minimum 6 years), access controls for audit data, and quarterly review procedures.”
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Suggested Customization
| Description | Default | Your Value |
|---|---|---|
| Name of my organization | Your Organization | |
| Applicable regulations (GDPR, HIPAA, SOX, FDA, ISO 27001) | GDPR, SOX | |
| Type of system being documented | financial application | |
| How long to retain audit logs | 7 years |
Create comprehensive audit trail policies and technical specifications meeting regulatory requirements for GDPR, HIPAA, SOX, FDA 21 CFR Part 11, and ISO 27001.
Research Sources
This skill was built using research from these authoritative sources:
- Audit Trail Requirements: Guidelines for Compliance and Best Practices Comprehensive audit trail compliance guidelines across frameworks
- Audit Trail Documentation: Best Practices Guide Key components and standardization best practices
- What Is an Audit Trail? - AuditBoard Core audit trail concepts and compliance framework requirements
- 21 CFR Part 11 Audit Trail Requirements FDA electronic records audit trail specifications
- Understanding Audit Trails: Implementation and Types Audit trail types and implementation approaches
- Audit Trails: Strengthening Compliance and Data Security Security benefits and regulatory framework overview
- What Is an Audit Trail? Complete Guide 2025 Modern audit trail implementation and storage considerations