English 
Funlead Co., Ltd., a subsidiary of Taiyo Holdings Co., Ltd. that handles ICT business, is pleased to announce that it has commenced a pilot test and development of integration functions for system integration between its generation AI utilization platform “STiV” and “Quality Designer for GxP,” a quality management system for the pharmaceutical industry provided by Union Think Co., Ltd.
“Quality Designer for GxP” is a system that digitizes and centrally manages quality control information such as complaint management, deviation management, and change management in the manufacturing of pharmaceuticals and medical devices. It supports the assurance of data integrity, including the prevention of tampering.
In the pharmaceutical industry, where strict quality and documentation management based on legal regulations (such as GxP) is mandatory, a vast amount of documentation has been accumulated of “past deviation records” and “corrective and preventive actions (CAPA) records” from the field. However, it has been difficult to access the necessary information immediately, leading to significant challenges such as reliance on individual judgment and increased investigation workload.
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This collaboration will enable the direct use of STiV’s powerful “Generative AI (RAG)” and “Cross-Search Function” on highly reliable quality control data accumulated within “Quality Designer for GxP.” This will promote the effective use of past knowledge in pharmaceutical operations, leading to improved quality management and faster decision-making.
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