Modern drug development relies on cloud software and outsourced vendors, making compliance with 21 CFR Part 11 and GxP more complex. This guide outlines best practices: adopt a risk-based validation approach, centralize regulated data across vendors into a trusted GxP repository, and partner with providers that offer built-in validation and integration. With continuous software updates and distributed collaborators, a holistic ecosystem and the right partner are essential. Egnyte helps unify content governance, ensure compliance, and protect sensitive data in today’s digital-first biopharma environment.

Join for free to read