Setting the Standard in Biopharmaceutical Innovation: The Path to AI and Compliance

Technical Insights

May 27, 2025

DSC05549 – 複製

In 2025, Amaran Biotech has advanced its digital transformation, aligning with its vision of an AI-driven factory while adhering to GxP compliance standards. By implementing advanced technologies, including Asana, an electronic work /project collaboration system, electronic Quality Management Systems (eQMS), and Computerized Maintenance Management Systems (CMMS), Amaran has significantly enhanced operational efficiency and compliance.

Amaran adopted Asana’s AI-enhanced Project / Collaboration System, revolutionizing task management and cross-functional communication. This technology streamlined project coordination, optimized complex workflows, and fostered seamless team collaboration. As a result, Amaran reduced task-related work hours by 25%, with a majority of employees reporting positive impacts on productivity and transparency. The AI-driven work and Asana AI enabled real-time task tracking and alignment with strategic goals, empowering employees to manage biotechnology processes more effectively.

Advanced technology further transformed Amaran’s operations through eQMS and CMMS, ensuring real-time data integrity and equipment reliability while meeting EU GMP Annex 11 and FDA 21 CFR Part 11 standards. These systems minimized errors, enhanced audit readiness, and reduced operational downtime, reinforcing GxP compliance. Additionally, employees leveraged AI agents to optimize Warehouse Management System (WMS) usage, enhancing inventory tracking and material traceability in GxP-compliant scenarios, further streamlining supply chain operations.

The sustained progress in 2025 highlights the critical role of advanced technology in Amaran’s success. Digitalization, as the foundational step toward an AI factory, ensures data integrity, traceability, and accountability. By integrating these cutting-edge solutions, Amaran Biotech is setting a new standard for innovation and compliance in the biopharmaceutical industry, paving the way for future AI-driven advancements.