
FDA Data Integrity Issues: Why Independent Oversight Is Essential
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current
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At Zenovel, we integrate our extensive expertise across a wide range of domains, from Good Clinical Practice to Regulatory Affairs, to present valuable insights and thought leadership. Each blog reflects our intense dedication to innovation, offering a forum to share our perspectives, groundbreaking ideas, and industry expertise. Through our blogs, we hope to uplift, inform, and support scientific, medical, and pharmaceutical innovation.
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be
A large quantity of unstructured data is produced by the healthcare sector from electronic health records (EHRs), clinical notes, medical
Internal audits play a crucial role in strengthening an organization’s Quality Management System (QMS) by identifying gaps, ensuring compliance, and
In the rapidly evolving pharmaceutical industry, a robust Pharmaceutical Quality Management System (QMS) is crucial for maintaining customer trust and
Substantial shifts are occurring in India’s pharmaceutical and healthcare sectors as a result of expanding patient numbers, more investment, and