The Real Meaning of Audit-Readiness in Clinical Research

Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in real time, particularly those with safety or regulatory implications.Being audit-ready means having the infrastructure to identify whether mistakes are isolated incidents or part of a larger trend requiring corrective action. Just like building credit requires a history of responsible transactions, regulatory credibility comes from demonstrating the ability to detect and resolve compliance issues effectively.Rather than aiming for unattainable perfection, sites should focus on maintaining a proactive compliance system that ensures high-risk issues are caught early and addressed. If you need guidance on achieving true audit readiness, KLF is here to help.Support the show

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