Beginning with a Holistic View of Data Integrity in Mind
Since the FDA issued final guidance on Data Integrity in 2018, the challenges have been many. The growth in observations has been substantial. With IT transforming dramatically over the last 20 years, the alignment of the people, processes, and tools and the data they collectively manage produces gaps in referential integrity both known and unknown, often being the root cause of product quality and patient safety issues. Kicking the proverbial can is not an option any longer. Data Integrity has a cost that puts businesses, no matter their size or maturity, into data integrity debt.