By Chris Wubbolt

Published in: IVT Podcast

Published on: January 12, 2021

This podcast is to help listeners better understand how to establish criteria around “critical data” and managing it within the data integrity programs of our own business.

What is critical data, and why is it important to define it? What are the first steps in establishing the criteria desired to identify critical data? Once we definite critical data, how fully integrate it into our data integrity program? How does “critical” data impact validation? What are some key considerations in critical data collection, and what are the biggest mistakes made here? Given that critical and non-critical data can be stored and maintained in the same database, what special protections of records controls do we need to be mindful of? What are the biggest challenges around critical data, and record controls? Can you highlight a couple of examples where data collection or storage failures have happened? Thinking about critical data reviews in your SOPs, review frequency and risk assessments. What are regulators expectations around critical data during an audit trail review? What are the most common failures or findings during these reviews?

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