Regulatory Audit Readiness Checklist for Life Science Executives
Executive Summary
Regulatory audits in life sciences are high-stakes events that can determine the trajectory of your organization. Whether facing FDA inspections, HIPAA audits, or international regulatory reviews, preparation is the difference between a clean outcome and costly remediation.
This checklist provides a comprehensive, actionable guide for life science executives to assess audit readiness across all major regulatory frameworks. From documentation and access controls to incident response and vendor management, every critical area is covered.
Designed for executives who need to ensure their organization is audit-ready without getting lost in technical details, this checklist translates regulatory requirements into clear, verifiable action items.
Download the full PDF for the complete analysis, frameworks, and implementation guidance.
Key Takeaways
- Pre-audit preparation checklist covering documentation, access controls, and evidence gathering
- FDA 21 CFR Part 11 readiness assessment for electronic records and signatures
- HIPAA Security Rule compliance verification across technical and administrative safeguards
- Vendor and third-party audit readiness including BAA verification and access reviews
- Incident response documentation requirements for regulatory audit scenarios
- Post-audit remediation tracking and continuous improvement framework
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