Overview
A leading Indian pharmaceutical and biotechnology company faced challenges in managing approvals for critical quality and GxP documents due to the COVID-19 pandemic. Ensuring compliance with 21 CFR Part 11 regulations while maintaining document traceability and security was a key concern. To address these issues, the company implemented Cygnature, 21 CFR compliant blockchain-based digital and electronic signing solution. This transformation
streamlined their document review and approval processes, improved workflow efficiency, and ensured regulatory compliance.