VIV Podcast

Identification and Management of Critical Data

Working in a data driven industry, as life science leaders we understand that their decisions are only as good as the quality of their data.  Ensuring data accuracy and consistency throughout its life cycle is was data integrity is all about.  As we are all swimming in data, we must recognize that not all data is good data, nor is it necessarily important to the outcomes of our organization. On today’s episode we invite Chris Wubbolt to help us better understand how to establish criteria around “critical data” and managing it within the data integrity programs of our own business.  

Discussed on this episode:

  • 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 do we 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
  • Examples where data collection or storage failures have happened
  • 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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