アガサ Company Overview

In January 2025, Okayama Medical Center introduced the digitization of clinical trial documents with the aim of improving operational efficiency. Furthermore, starting in April 2026, they began utilizing AI functions, and currently, they are advancing both traditional operations and those utilizing AI in parallel. In this presentation, we will candidly discuss the changes that have occurred in actual operations and workflows due to the use of AI functions, from the perspective of on-site personnel. We plan to share experiences gained in daily operations, including expectations before implementation, insights felt during actual use, and operational innovations and challenges. This will provide practical examples that will be useful not only for facilities considering digitization and AI utilization but also for those already operating these systems as they think about future applications. Additionally, the background of Okayama Medical Center's digitization implementation and operational structure will be introduced in a separate case article that will be published later. This webinar will focus on the actual use of AI functions and the real voices from the field, which may not be fully conveyed in the case article.

As the utilization of generative AI in business progresses, the pharmaceutical and medical device industries are focusing on practical issues such as "Is generative AI subject to CSV (Computer System Validation)?" and "How should AI validation be conducted?" In this content, we present on-demand sessions that explain CSV compliance and AI risk management in generative AI systems, based on the concepts of FDA CSA (Computer Software Assurance) from previously well-received webinars. ■Content - Determining the applicability of CSV to generative AI systems - Methods for conducting AI validation - Key focus areas during inspections - Points for ensuring data integrity - AI literacy education and Human in the Loop - Considerations for internal controls in the utilization of generative AI *This content is based on information as of April 22, 2026. *The information provided is intended for general informational purposes and does not guarantee specific actions or compliance.

In recent years, as the importance of data integrity (DI) compliance in GMP environments has increased, there has been a growing call to deepen understanding of 21 CFR Part 11. This content introduces an on-demand presentation that organizes the background of Part 11, its relationship with DI, and its positioning in CSA guidance, while explaining the basic concepts of electronic records and electronic signatures. ■Content - Background and basic concepts of Part 11 - Relationship with data integrity (DI) - Positioning in CSA guidance - Basic requirements for electronic records/electronic signatures *This content is based on information as of March 17, 2026. *The information provided is intended for general informational purposes and does not guarantee specific compliance or suitability.