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The Real Meaning of Audit-Readiness in Clinical Research

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Manage episode 475467349 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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

  continue reading

216 episodes

Artwork
iconShare
 
Manage episode 475467349 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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

  continue reading

216 episodes

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