GxP Audit Trails For FDA Compliance

Source: Egnyte

Today, modern biotechs are moving compounds to the clinic at a faster pace than ever before. As a result, many companies struggle ensuring a strong compliance envelope as they transition from an R&D culture to a more-structured, regulated one. One of the key challenges involves computerized systems and data integrity. In fact, over 50% of citations by the FDA include the aforementioned issues.

In this demo, we will cover Egnyte for Life Sciences platform overview focusing on audit trails, versioning, and reporting capabilities.

What you will learn:

  • How to maintain compliance with 21 CFR Part 11
  • Capabilities of Egnyte for Life Science’s audit trails
  • How to generate reports on data and users

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