In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates (RCA), explore the resurgence of data integrity issues and the focus of global regulators. Given the recent rise in data integrity-related allegations, global regulators including the FDA, MHRA, World Health Organization and PIC/S have released documents to educate the pharmaceutical industry on data integrity concepts. Many of these guidelines include an element of quality culture.

We analyze these policies and examine the history of data integrity, what it means to have a quality culture, and how to integrate a quality culture into the product lifecycle. Data integrity is no longer just a concern of the quality control department, but a concern of the entire organization. This leads to the concept that your data is only as good as your company's culture.

https://www.rcainc.com/podcasts/

Episode No. 002, original release date: 08.05.2019

Please take the opportunity to connect with your friends and family and share this video with them if you find it useful.