Computer System Validation (CSV)

Computer system validation ensures that systems used in regulated environments consistently perform as intended and comply with FDA requirements. CSV is essential for systems supporting GxP activities, including clinical, quality, manufacturing, and safety operations.

A risk-based validation approach focuses validation effort where it matters most, aligning system complexity with regulatory expectations. Validation activities typically include defining intended use, assessing risk, and documenting system performance.

Well-executed CSV supports data integrity, regulatory compliance, and inspection readiness.

CSV activities commonly include:

• Validation planning and risk assessment

• Part 11 compliance evaluation

• SaaS and cloud system validation

• Change control and revalidation

• Validation documentation review