CSV and CSA
From document-heavy validation to risk-based assurance
Computer System Validation (CSV) is the broader lifecycle discipline used to establish and maintain evidence that a computerized system is fit for intended use in a regulated context.
Computer Software Assurance (CSA) is FDA’s risk-based approach for computers and automated data-processing systems used in medical-device production or quality management systems. FDA’s February 2026 final guidance emphasizes establishing confidence, identifying where additional rigor is appropriate, and selecting suitable assurance methods.
What changes in practice:
• Begin with intended use and quality risk.
• Distinguish high process risk from lower-risk functions.
• Use scripted testing where risk or complexity warrants it.
• Use exploratory, unscripted, or automated methods when they provide reliable evidence.
• Retain objective evidence that is sufficient, clear, and reviewable.
CSA does not eliminate validation, documentation, or accountability. It helps teams reduce low-value test volume and focus effort on product quality, patient safety, data integrity, and dependable operation.