アガサ Company Overview

While the use of generative AI in business is expanding, it is crucial to discern plausible misinformation and follow-up responses in GxP environments, as well as how to verify and document them. In this webinar, we will explain how generative AI can make mistakes and the risks associated with its business use, while also introducing specific methods to enhance output reliability, such as prompt design, grounding to primary information, verification through Human-in-the-Loop, and how to leave explainable records and audit trails for inspections and audits. You will take home criteria for appropriately utilizing generative AI within a quality assurance framework, rather than simply deciding whether to "use or not use" it. 【Program】 Part 1: 14:05–15:00 "Regulatory Requirements & Inspection Response Seminar Using Generative AI, Session 4 Don't Be Deceived by Generative AI! - Risks of Using Generative AI and Proper Usage Methods -" Koichi Murayama, E-Compliance Co., Ltd. Part 2: 15:00–15:30 "Introduction and Demonstration of Agatha Solutions" Agatha Co., Ltd. Sales & Marketing Department, Quality Group Part 3: 15:30–15:50 Q&A Session

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.