CSV: validation by intended use and risk
Computer system validation starts with the quality-related task a system is intended to perform. This working structure helps you plan with QA.
Updated: 9 September 2026 · Editorial team: VALNARO AG
Intended use and risk
Document processes, users, data and system boundaries. Assess how failures affect product quality, data integrity or decisions. Use this to define testing needs and approval responsibility.
Requirements and evidence
Link requirements to configuration and suitable tests. Cover roles, approvals, interfaces, migration and error cases. Record deviations and assess them before approval.
Maintain the validated state
Plan change control, training, operations and periodic review. After upgrades, derive regression testing from the impact assessment. This checklist supports planning and does not certify validation.
This information provides orientation and does not replace legal or regulatory advice. Applicability, transitional provisions and obligations must be checked for each product.