[Webinar on 5/27] Methodology for Applying Digital Twin to Pharmaceutical Manufacturing Processes

Enabling the electronic originalization of documents related to specific clinical research, achieving the efficiency of the certified clinical research review committee's secretariat operations!

Agatha CRB is a cloud solution that streamlines document management related to specific clinical research and the operations of certified clinical research review boards. It allows for the transition from paper-based document management to securely digitizing specific clinical research application materials and documents submitted to certified clinical research review boards, enabling centralized management in the cloud. The organized folder structure for each research project significantly reduces the burden of document exchange and submission tasks among stakeholders. Additionally, the document creation assistance feature allows for the registration and use of in-house forms as templates, facilitating the smooth creation of application materials and committee submission documents, contributing to reduced work time and improved accuracy. Furthermore, the automatic notification feature for implementation status and expected completion dates reduces the risk of missing applications and strongly supports business management. Moreover, flexible permission settings allow for the secure sharing of highly confidential documents. As part of the system's infrastructure enhancement measures, a robust data center is utilized, ensuring that important documents can be managed with peace of mind. *For more details, please refer to the PDF materials or feel free to contact us.*

• File 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

Professor Suzuki from Tokyo University of Science will be speaking! "GMP Training and Education Considering Recent Developments" Free on-demand webinar video is now available!

Webinar video distribution application here: https://go.2.agathalife.com/l/1014252/2024-07-11/314jj 【Agatha SOP】 A cloud service that centrally manages the original documents of Standard Operating Procedures (SOP) and training records. A highly reliable and secure system compliant with the Ministry of Health, Labour and Welfare's ER/ES guidelines and FDA 21 CFR Part 11. It allows for the registration and automatic version management of SOPs, reviews and approvals, audit trails, expiration reminders, and sharing of the latest SOP versions across multiple devices. It supports proper change management to ensure the reliability of SOPs. Additionally, it manages training records related to SOPs, significantly reducing the burden on personnel and enhancing productivity. <Recommended for> ● Those whose management of Standard Operating Procedures (SOP) is manual, incurring time and costs ● Those who want to detect SOP expiration in advance ● Those who want to share the latest or replacement SOPs immediately ● Those who want to reduce the burden on the person in charge by informing each group ● Those who want to have an overview of individual training participation status for each SOP ● Those who want to implement e-learning (quizzes and tests) for training.

• Document and Data Management

In the operation of drawings, do you face challenges such as "taking too long to find," "uncertainty about whether it's the latest version," or "high likelihood of confirmation errors"? By utilizing CADSUPER's barcode function (optional), you can reliably connect drawings and information, allowing for a smooth advancement of DX in drawing utilization. In this seminar, we will introduce how using barcodes can change: - Drawing management and search - Confirmation and cross-checking tasks - Information collaboration with the field This content is recommended not only for existing users but also for those considering improving the efficiency of drawing operations and reducing errors.

Daitō Shikō Co., Ltd. will be exhibiting at the "International Fire and Disaster Prevention Exhibition" held at Shirakawa Park in Nagoya City, Aichi Prefecture, from Thursday, May 28, 2026. At the exhibition venue, we plan to showcase goods that are perfect for fire prevention events and recruitment activities for members. If you are looking for SP tools, promotional items, or novelties, please be sure to visit our booth.

[Speaker] Miho Ko Shimada, Partner Attorney, Mori Hamada & Matsumoto Law Firm, Foreign Law Joint Enterprise [Key Lecture Content] The movement towards the implementation of CCS, which is positioned as an essential technology for decarbonizing hard-to-abate industries, is gaining momentum in Japan. Among the "advanced CCS projects" selected for business commencement in the early 2030s, some pipeline projects have progressed to the exploratory drilling stage. For shipping transport projects, discussions are underway to create mechanisms for clustering CO2 sources and improving shipping transport efficiency. In this seminar, following the full enforcement of the CCS Business Act on May 22, we will organize the current state of the business environment related to CCS and examine the latest discussions at the Agency for Natural Resources and Energy and the Ministry of the Environment (based on information available at the time of the event) from a legal perspective as we consider the shape of CCS projects leading to Final Investment Decision (FID). [Lecture Items] 1. Current state of the business environment related to CCS 2. Overview of the CCS Business Act 3. Overview of the cost difference support system for CCS projects (pipelines) 4. Structural considerations through the CCS value chain 5. Q&A / Business card exchange

Alpha Electronics Co., Ltd. will be exhibiting at the "JISSO PROTEC 2026 (27th Assembly Process Technology Exhibition)" held at Tokyo Big Sight. This exhibition is a comprehensive showcase of electronic component assembly technology. It will be held concurrently with eight other exhibitions, including the JPCA Show, under the general title of "Total Solutions for Electronic Devices." We look forward to your visit.

The "National Roadshow," which has been held at various venues across Japan, will be transformed into an "online format." From now on, once a quarter, we will introduce content that is useful for a wide range of participants, from those considering implementation to those who want to deepen their use of Archicad/BIM, showcasing how design workflows change through the use of these tools, along with actual user cases. Participation is free, so please join us. The first online National Roadshow will focus on the theme of drawing review. Unlike the traditional 2D drawing-centered review, there is a demand for designers and application officers to adapt to a new review process based on BIM data. This online seminar will clarify the overview of the BIM drawing review system, the concepts behind the review, and the key points to be understood in practice, providing an easy-to-understand explanation of the basic knowledge necessary for application procedures. We will also address questions such as "What should I prepare first?" and "To what level should I respond with BIM?" from a practical perspective. Please join us as a first step toward using BIM for application procedures and as a platform for organizing information right after the system's launch. Since it is held online, you can participate from anywhere in the country.