Delivering Risk-Based CSV & Part 11 Compliance

Computer systems supporting GxP activities must be reliable, compliant, and appropriately controlled without unnecessary burden.

I provide risk-based CSV aligned with 21 CFR Part 11, EU Annex 11, and GAMP 5, tailored to your systems and organizational complexity.

The focus is on achieving compliance efficiently, ensuring systems are inspection-ready without overengineering documentation.

This includes:

• Development of validation strategies and risk-based methodologies

• System classification and GxP applicability assessments

• Validation planning, protocol development, and documentation

• Oversight of vendor validation activities and documentation review

• Assessment and remediation of Part 11 compliance gaps

All work is designed to ensure your systems are reliable, secure, and inspection-ready, without overengineering or unnecessary administrative burden. You should never have to worry, “We’re about to get inspected and our systems aren’t ready.”