White Paper: Data Pedigree – Getting to Know Your Data
Ronald D. Snee, PhD
Snee Associates, LLC
In the pharmaceutical world we talk a lot about Data Integrity. The FDA (2016) published A guidance for industry on matters involving data integrity. We hear analysts talking about Data Quality. Legal proceedings often question the “Chain of Custody of the Data.” Metadata is also of concern when assessing Data Integrity (FDA 2016). I conjecture that these issues can be effectively discussed, understood, and assessed by using a common structure called “Data Pedigree,” the subject of this article.