
|Articles|October 13, 2021
Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records
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, Egnyte will chronicle recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
Trending on Applied Clinical Trials Online
1
Patient Recruitment in Clinical Trials: Why the Industry's Longstanding Approach Is No Longer Fit for Purpose
2
ACT Brief: Local-First Communication Design, RBQM Financial Impact, and First Oral PCSK9 Inhibitor
3
Applying Systems Thinking to the Future of Clinical R&D
4
ACT Brief: Portfolio-Level Recruitment Strategy, Structural Change Through Systems Thinking, and Kidney Function Preservation in IgAN
5