Critical thinking

CSA process begins here

We at Valina, have structured a 3-pronged approach to transition from CSV to CSA.

Critical Thinking

Qualitative Risk-based testing

Reliance on automation

Shift to quality as opposed to evidence-driven validation approach >> Less documentation with more focus on high-risk documents

Assess risks based on public health, patient safety and quality design >> Rather than business categorization or compliance categorization.

Complete transition to automated test tool >> for all non-high-risk systems.

Rethinking Computerized system categorization >> Needs a radical approach

Remodelling system risk assessment >> Categorize high-risk and non-high-risk systems/areas.

Gradual risk-based transition of high-risk systems to automated test tools.

Relying more on supplier audits, supplier test data >> Optimizing validation efforts

Design and implement methods of testing >> Scripted vs Unscripted testing

Promoting cases for automation during annual periodic reviews or Process Improvement initiatives.

Valina Services

SINGAPORE (048616)

Validation services

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