[Webinar on 11/7] What is the 2025 Amendment to the Pharmaceutical and Medical Device Act? One-stop explanation of quality assurance and stable supply countermeasures.

For companies looking to achieve paperless solutions in line with Part 11 compliance! We enable a small start in both cost and scale.

Agatha Basic is a document management cloud service equipped with basic functions for sharing, storing, and managing documents related to clinical trials and research. It is a high-security, highly reliable system compliant with ER/ES guidelines, FDA regulations, and CFR 21 Part 11. It is simple and easy to use, and during implementation, dedicated consultants provide support, along with ongoing assistance from a help center, ensuring that even first-time users can use the document management system with confidence. <Recommended for> ● Those who are managing documents on paper and want to reduce the enormous workload and costs involved. ● Those who want to manage and share documents in compliance with ER/ES and CFR Part 11. ● Those who wish to achieve seamless information sharing and management beyond location and time constraints, whether on the go or across multiple facilities. ● Those who find file management complicated due to not knowing the latest version or accidentally overwriting files. ● Those troubled by the rising costs, complexity, and operation of existing systems. ● Those considering the latest security measures and disaster/pandemic response (BCP/BCM). *For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

For life science companies! Database of quality event information such as CAPA and change management.

Agatha QMS is a document and quality management cloud service that enables the management of quality processes (such as CAPA, deviations, complaint management, audit management, change management, and other quality event information) necessary in the pharmaceutical and medical device industries. It is a highly secure and reliable system that complies with the Ministry of Health, Labour and Welfare's ER/ES guidelines and FDA 21 CFR Part 11 requirements, supporting quality management for GxP-related operations that require strict control. Agatha revolutionarily integrates process management and document management, promoting user adoption with simple and easy-to-use operability. By linking with Agatha SOP, it achieves further reliability, labor-saving, and efficiency in quality management activities. <Features of Agatha QMS> ● Compliant with various regulations for the pharmaceutical and medical device industries ● Creation of original input screens, enabling database integration ● As a cloud service, access to the system is possible by granting licenses to necessary personnel, regardless of internal or external sites ● Support services for CSV (PQ) implementation available *For more details, please refer to the PDF materials or feel free to contact us.

• Document and Data Management

Mr. Murayama from eCompliance Co., Ltd. will be speaking! Seminar on Data Integrity in relation to deviations, CAPA, change management, etc.

You can watch the video of the webinar held on May 17, 2024. Seminar on Data Integrity in Deviation, CAPA, and Change Management ~ Event management to comply with regulatory requirements in Japan, the U.S., and Europe ~ As data integrity measures progress, the pharmaceutical and medical device industries are required to manage a multitude of event data, including deviation management, change management, CAPA, nonconformance management, training, and audits. There are limitations to managing data based on human input, such as with Word and Excel, and we often hear about situations where related documents are stored separately due to paper management, making it impossible to manage them in a linked manner. Event data should inherently be interconnected, and it is crucial to have quick access to related data. So, how can we effectively manage these often complex data sets? In this seminar, we will clearly explain the principles of event management and how to ensure data integrity.

• others

Announcement of Exhibition. We will be exhibiting at the Reborn Challenge Showcase in Grand Green Osaka JAM BASE. [Exhibits] Bioplastics Sakura plates Cutlery

We are pleased to announce that our company will be exhibiting at "EdgeTech+ 2025" (held in Yokohama). <Overview of EdgeTech+ 2025> Exhibition Name: EdgeTech+ 2025 (https://www.jasa.or.jp/expo/) Dates: November 19 (Wednesday) to November 21 (Friday), 2025, 10:00 AM to 5:00 PM (until 6:00 PM on November 20, Thursday) Venue: Pacifico Yokohama Exhibition Hall / Annex Hall Organizer: Japan Embedded Systems Technology Association Admission: Free (pre-registration required) <Booth Information> Booth Number: CS-07 <Main Exhibits> - UHF Band RFID Reader/Writer Module [TPURID2100] - 920MHz Band LPWA Wireless Communication Module [TPSW9] - 2.4GHz Band Wireless Communication Module [TPBPM] - Positioning Starter Kit We understand that you may be busy, but we sincerely hope you will take this opportunity to visit us and stop by our booth.

We are pleased to announce that our company will be exhibiting at the "Industrial Exchange Exhibition 2025." <Overview of the Industrial Exchange Exhibition 2025> Exhibition Name: Industrial Exchange Exhibition 2025 (https://www.sangyo-koryuten.tokyo/) Dates: November 26 (Wednesday) to November 28 (Friday), 2025, 10:00 AM to 5:00 PM Venue: Tokyo Big Sight, West Halls 1 and 2 Admission: Free (pre-registration required) <Booth Information> Booth Number: B-04 (within the Tokyo Business Frontier Pavilion) <Main Exhibits> - UHF Band RFID Reader/Writer Module [TPURID2100] - 920MHz Band LPWA Wireless Communication Module [TPSW9] - 2.4GHz Band Wireless Communication Module [TPBPM] - Positioning Starter Kit We understand that you are busy, but we sincerely hope you will take this opportunity to visit us and stop by our booth.

100% participant satisfaction! Packed with useful information for ISMS managers! You can watch the video of the "ISMS Manager Study Session" held in Shinbashi in September 2025. The theme this time is "Latest Trends and Information Leakage Countermeasures." 【What You Can Learn】 ● The latest trends in ISMS audits and what to do before the next audit - How to efficiently run the PDCA cycle - Recent trends in audits - What to do before the next audit ● Recent trends in information leakage incidents and unauthorized access, and the information security measures to focus on now - Recent trends in information leakage incidents and unauthorized access - Key points for countermeasures based on these trends - Information security measures to focus on now 【Recommended For】 - Executives and personnel from companies that have obtained ISMS certification - Those who want to know what to prepare for the next ISMS audit - Those who want to know how to respond to recent security trends - Those who want to operate ISMS more efficiently. You can also download the materials distributed at the seminar. Please apply!

[Speaker] Taigo Isobe, Senior Manager, Innovation Center, Innovation Technology Department, NTT Data Corporation [Key Lecture Content] Quantum computers are attracting attention as a new computational mechanism based on quantum mechanics, providing innovative solutions to complex and large-scale problems that have been difficult to handle with traditional classical computers. In this lecture, I will first overview the foundational technologies and current status of quantum computers, organize the application examples that have been highlighted in the financial and chemical fields, and then outline the potential in new application areas such as odor reconstruction, weather forecasting, and digital agriculture. I hope you will realize that quantum computers are not just an extension of computational technology but are expanding into diverse areas such as perception, environment, and human sensibility.