In this episode, host Erika Porcelli is joined by Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates (RCA), to explore the resurgence of data integrity issues and the heightened focus of global regulatory agencies. With a notable increase in data integrity-related citations, regulatory bodies such as the FDA, MHRA, World Health Organization, and PIC/S have released new documents aimed at reeducating the pharmaceutical industry on the importance of data integrity.
Erika and Susan delve into these guidelines, breaking down the key elements and examining the historical context of data integrity issues. They discuss what it means to have a quality culture and the crucial role it plays in maintaining data integrity throughout the product lifecycle. The conversation emphasizes that data integrity is no longer just the responsibility of the quality control unit but a concern for the entire organization. This holistic approach underscores the idea that the reliability of data is inherently linked to the culture of the company.
Listeners will gain insights into the specific recommendations provided by global regulatory agencies, including the integration of quality culture principles into daily operations. Susan shares practical advice on how companies can foster a culture that prioritizes data integrity, ensuring that all employees understand its importance and their role in upholding it.
This episode is essential for pharmaceutical professionals, quality assurance specialists, and regulatory compliance experts who want to stay informed about the latest developments in data integrity and quality culture. By understanding and implementing these guidelines, organizations can better prepare for regulatory scrutiny and enhance the reliability of their data.
Tune in to learn more about the evolving landscape of data integrity and the steps you can take to build a strong quality culture within your organization.