RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.
|Articles|January 10, 2023
Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records (Jan 2023)
Author(s)Egnyte
Drug development has dramatically changed over the past ten years. Specifically, when it comes to GxP compliance and validation. Many biopharma companies struggle to adopt new technologies because of the uncertainty of how to comply with FDA regulations. In this white paper, we will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
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