The 5th "Tokyo Women Entrepreneurs Award" in the Continuous Growth Category was awarded to Agatha, a provider of clinical trial and quality document management cloud systems, with CEO Chiemi Kamakura receiving the honor!

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

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

Easily and quickly create and customize an environment tailored for exams! Create, share, and store essential documents and clinical trial-related documents on a project basis.

Agatha eTMF is a document management cloud service designed for the creation, sharing, and storage of essential clinical trial documents and trial-related documents on a project basis. To manage hundreds of types of documents, it has established an industry-standard folder and document structure, allowing for easy and speedy environment setup. It dramatically improves efficiency and reduces labor while ensuring reliability for all operations related to clinical trial documents among sponsors, implementing medical institutions, and contractors (such as document sharing, editing, printing, sending, storage, and monitoring). Customers can choose a structure tailored to their trials. <Features of Agatha eTMF> ● Complies with regulatory requirements and enables electronic original documents ● Pre-set industry-standard folder and document structure for easy and speedy environment creation ● Templates for trial-specific structures with flexible customization options ● Automatic document distribution to "facilities," with a simple and user-friendly UI ● Unprecedented low pricing ● Supports Japanese and English *For more details, please refer to the PDF materials or feel free to contact us.

• File Management

Fukuda Corporation has been pursuing leak detection for 60 years and is dedicated to advancing the future of leak testing. 【 Supporting Various Leak Tests: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing performance. We will propose suitable testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the most suitable leak testers for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015)

This is a collection of links to Fukuda's technical columns. It covers various topics related to leak tests and more... Please check the related links for more information.

At construction sites, temporary parking lots may be established for workers and construction-related vehicles. On unpaved ground, mud and ruts can easily occur due to rain, which may hinder vehicle access. Hyper CLT mats are civil engineering materials that utilize wood CLT. By laying them in temporary parking lots, a suitable environment for vehicle passage and parking can be created while protecting the ground. They can be laid only in the necessary areas, and after the construction is completed, they can be removed and repurposed for temporary roads or access routes. The 5×10 panels weigh approximately 230 kg, and the 5×20 panels weigh about 460 kg, making them lightweight and easy to install and remove even with small machinery, allowing for changes in parking space. Additionally, they offer benefits unique to wood, such as glare reduction, noise reduction, and CO2 fixation. They are registered as a technology with the Ministry of Land, Infrastructure, Transport and Tourism under NETIS as "TH-250021-A," and can be utilized for the development of temporary parking lots and innovative public works.

Metal cracks are one of the concerns in equipment maintenance operations. Conventional welding repair methods can change the base material around the crack due to heat, leading to residual stress and deformation, which always carries the risk of "crack recurrence" and "secondary damage." Hinode Water Supply Equipment Co., Ltd.'s "Mechanical Stitching Method" is a new technique that allows for the repair of metal cracks without applying heat. By using special bolts and reinforcement plates, the crack is physically removed without affecting the base material at all. Repairs can be made even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. For more details, please contact us or download the catalog.

Metal cracks are one of the concerns in equipment maintenance operations. Conventional welding repair methods can alter the base material around the crack due to heat, leading to residual stress and deformation, which always carries the risk of "crack recurrence" or "secondary damage." Hinode Water Supply Equipment Co., Ltd.'s "Mechanical Stitching Method" is a new technique that allows for metal crack repair without applying heat. By using special bolts and reinforcement plates, the crack is physically removed without affecting the base material with heat. Repairs can be made even in environments where open flames cannot be used. Since no heat is applied, the disassembly of equipment is minimized. For more details, please contact us or download the catalog.