Funlead Begins Development of System Integration Between its Generative AI 'STiV' and Union Sync's 'Quality Designer for GxP' for the Pharmaceutical Industry

Funlead Corporation (HQ: Toshima-ku, Tokyo; President & CEO: Keiichi Kobayashi; hereinafter 'Funlead'), a subsidiary of Taiyo Holdings Co., Ltd. (HQ: Toshima-ku, Tokyo; President & CEO: Hitoshi Saito; TSE Code: 4626; hereinafter 'Taiyo Holdings') responsible for the ICT business, announces the start of pilot testing and development of integrated functions for system linkage between its generative AI utilization platform 'STiV' and 'Quality Designer for GxP,' a quality management system for the pharmaceutical industry provided by Union Sync Co., Ltd. (HQ: Chuo-ku, Osaka; Representative: Hiroshi Nishitani; hereinafter 'Union Sync'). 'Quality Designer for GxP' is a system that digitizes and centrally manages quality-related information in the manufacturing of pharmaceuticals and medical devices, such as complaint management, deviation management, and change management. It helps ensure data integrity, including preventing data tampering. In the pharmaceutical industry, where strict quality and document management based on legal regulations (such as GxP) is mandatory, 'past deviation records' and 'corrective and preventive action (CAPA) records' from the field are accumulated as vast documents. However, immediate access to necessary information is difficult, leading to major challenges like reliance on individual judgment and increased investigation time. This integration will allow for the direct use of STiV's powerful 'Generative AI (RAG)' and 'cross-sectional search function' on the highly reliable quality management data accumulated within 'Quality Designer for GxP'. This will promote the effective use of past knowledge in pharmaceutical operations, leading to the advancement of quality operations and faster decision-making. ■Key Benefits of this Integration (1) 'Instant Search and Analysis' of Past Non-conformity and CAPA Information: AI instantly extracts similar cases from the vast number of past cases within 'Quality Designer for GxP'. This supports rapid, evidence-based decision-making without relying on veteran experience. (2) Improved Efficiency and Consistency in Document Creation: 'STiV' references past inquiry responses and corrective action details to assist in generating drafts for new documents, maintaining consistent document quality across the organization. (3) Elimination of Knowledge Silos: It resolves the 'don't know who to ask' situation, creating an environment where anyone can access the company's 'wisdom' through 'STiV'. STiV and Quality Designer for GxP integration image. STiV top screen. Furthermore, a demonstration of this integrated function will be conducted at the Funlead booth at 'Pharma DX EXPO' within 'Interphex Week Tokyo 2026,' held at Makuhari Messe from May 20 (Wed) to May 22 (Fri), 2026. ■About Exhibiting at 'Interphex Week Tokyo 2026' During the exhibition, we will introduce and demonstrate this integrated function for STiV at the Funlead booth. You can experience a concrete image of generative AI application in pharmaceutical operations by viewing the actual user interface. Exhibition: 'Interphex Week Tokyo 2026' (2nd Pharma DX EXPO Tokyo / Digital Support for Pharmaceutical Industry Expo) Dates: May 20 (Wed) - 22 (Fri), 2026, 10:00-17:00 Venue: Makuhari Messe Booth Number: 19-5 (Hall 4, Manufacturing & Quality Control DX Zone) Funlead booth (image). [Related Information] ■Generative AI Knowledge Management System 'STiV' Service Site: https://www.stiv.jp/ STiV is a service born from solving challenges actually faced by Taiyo Holdings Group's medical and pharmaceutical business. In highly specialized tasks, there was a tendency to rely on individual experience and know-how, hindering knowledge sharing across the organization. STiV solves these issues that lead to knowledge silos and decreased productivity, accelerating knowledge sharing and technology succession for the entire organization through generative AI. STiV chat screen. Effects of STiV implementation in Taiyo Pharma's regulatory affairs department. Taiyo Holdings is a leading company with the world's No. 1 market share (*) in solder resist (an insulating material that protects the surface of printed circuit boards used in various electronic devices). In addition to its electronics business, which develops and sells chemical materials for electronic components crucial to many electronics products, it also engages in various business activities leveraging the power of chemistry, including a medical and pharmaceutical business that manufactures and sells medical drugs and provides contract manufacturing services; an ICT business that digitally supports our group and customers; a fine chemicals business for contract synthesis development; an energy business promoting renewable energy; and a food business operating plant factories. Funlead is an IT company that digitally supports the businesses of the Taiyo Holdings Group and external customers. It has realized a business model that provides one-stop services from consulting, design, development, to maintenance and operation, creating external products from solutions to group challenges. It focuses on DX support, especially for the manufacturing and pharmaceutical industries, utilizing the latest technologies like generative AI. *According to '2024 Current Status and Future Prospects of Advanced Electronics Materials' by Fuji Chimera Research Institute, Inc. ■Funlead Corporation Company Profile [Head Office] 15F, Metropolitan Plaza Building, 1-11-1 Nishi-Ikebukuro, Toshima-ku, Tokyo 171-0021 [Representative] Keiichi Kobayashi [Established] March 26, 2013 [Capital] 80,000 thousand yen [Number of Employees] Standalone: 219 (including 182 engineers), Consolidated: 385 (as of April 1, 2025) URL: https://www.funlead.co.jp/