iSpeak Blog

Beginning with a Holistic View of Data Integrity in Mind

Scott Cady
Data Integrity Banner

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.

Fortunately, the Life Science Industry is not alone in this adventure to reduce the debt. In a few weeks, my colleagues, Kevin Martin, Director of Strategic Business, and Adil Seddiq, Senior Consultant, Azzur Group, will join me in a webinar sharing how we designed a pathway that leverages the GAMPⓇRDI Guide (and related GAMP Good Practice Guides) produced and curated by ISPE and the Data Management Maturity model from CMMI Institute. While our team is deeply technical, this webinar is designed for a broad audience.

We will baseline the key concepts with concrete practical definitions. We’ll also pull common drivers of pain and gain from our decades of real-world experience that informed the development of our model and tease out how Data Integrity fits across the full life cycle of data, similar to a System Development Lifecycle (SDLC). Finally, we will guide the audience through both why and how we mapped the two maturity models to data integrity concepts with some key lessons to follow.

The Data Integrity Pathways to Maturity webinar will be held Thursday, 11 November, 1100-1230 ET.

Register Now!