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Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records

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.

You will learn how to:

• Leverage automation and validation
• Centralize data from your ecosystem
• Become future-proof with the right technology partner