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What You Need to Know About a Risk-Based CSV Approach

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Refocusing validation is driven by the need to ensure patient safety, product quality, and data integrity.

Risk-based CSV Approach FDA-regulated companies must consider a wide range of emerging risks as they adapt their business practices to changing regulatory compliance and market-driven pressures for a risk-based CSV approach. Some of these pressures include globalization, the advancement of technology and expanding stakeholder expectations. Risks are no longer confined to discrete areas and functions within...

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