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By - Kossi Molley (he/il)

Navigating the Complex Landscape of CSV and CSA

Understanding and navigating the complexities of these frameworks is essential for organizations seeking efficiency, innovation, and regulatory alignment.

By - Kossi Molley (he/il)

Impact of Validation by Design in Biopharma

What should we expect from Validation 4.0 Validation by design a.k.a Validation 4.0 is a new approach to validation in the biopharmaceutical industry that is designed to be more efficient, effective, and compliant with regulatory requirements. It is based on the principles of risk-based thinking, quality by design, and data integrity by design.   Key