In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates (RCA), examine the resurgence of data integrity issues and the focus of global regulatory agencies. With the recent rise in data integrity-related citations, global regulatory bodies including the FDA, MHRA, World Health Organization, and PIC/S, have released documents to reeducate the pharmaceutical industry on data integrity concepts. Many of these guidelines include an element of quality culture.
We break down these guidelines and examine the history of data integrity, what it means to have a quality culture, and how to integrate a quality culture in the product lifecycle. No longer just the concern of the quality control unit, data integrity is the concern of an entire organization, bringing forth the concept that your data is only as good as the culture of your company.