Computer System Validation (CSV) / CSA (Computer Software Assurance)

Definition

Computer System Validation is the documented process of demonstrating that a computerized system, such as an EBR, MES, or LIMS, consistently performs as intended and meets its predefined requirements. Computer Software Assurance is the FDA's more recent, risk-based evolution of this concept, emphasizing critical thinking and testing effort proportional to patient risk rather than exhaustive documentation of every function.

Benefits

A well-scoped validation approach ensures systems are genuinely fit for purpose without generating excessive, low-value documentation. The shift toward CSA in particular allows quality and IT teams to focus validation effort on high-risk functionality, such as calculations affecting product quality, rather than treating every system feature as equally critical.

Use Case

A company implementing a new EBR platform applies a CSA-based risk assessment, identifying that automated in-process limit checks are high-risk and require rigorous scripted testing, while a low-risk cosmetic UI feature receives a lighter-touch, unscripted test approach.

Frequently Asked Questions (FAQ)

Related Terms

• GAMP 5 (Good Automated Manufacturing Practice)
• System Validation Lifecycle
• URS (User Requirements Specification)