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Risk-Based Validation &
Risk-Based Validation &
Computer Software
Assurance (CSA)
Focus resources where it matters most.
We apply a risk-based approach to validation
and follow FDA’s Computer Software Assurance
principles to ensure the right level of control
for your systems and business needs.
- Risk
AssessmentRisk AssessmentIdentifying which system functions affect patient safety, product quality or data integrity, so testing effort goes where the risk is highest. - Lifecycle
ApproachLifecycle ApproachManaging a system from planning and requirements through operation and retirement, keeping it in a validated state the whole way. - Software
AssuranceSoftware AssuranceA risk-based CSA approach that favors critical thinking and efficient, fit-for-purpose testing over excess documentation.