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Shift to quality as opposed to evidence-driven validation approach >> Less documentation with more focus on high-risk documents
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Assess risks based on public health, patient safety and quality design >> Rather than business categorization or compliance categorization.
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Complete transition to automated test tool >> for all non-high-risk systems.
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Rethinking Computerized system categorization >> Needs a radical approach
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Remodelling system risk assessment >> Categorize high-risk and non-high-risk systems/areas.
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Gradual risk-based transition of high-risk systems to automated test tools.
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Relying more on supplier audits, supplier test data >> Optimizing validation efforts
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Design and implement methods of testing >> Scripted vs Unscripted testing
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Promoting cases for automation during annual periodic reviews or Process Improvement initiatives.
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