The clinical trial/quality document management cloud system 'Agatha' has obtained the JIIMA 'Electronic Document Software Legal Requirements Certification'.

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 Co., Ltd. has been pursuing leak detection for 60 years and is committed 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 properties. We will propose the appropriate 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)

Japan is among the top 10 countries in the world with frequent earthquakes. The 2020 White Paper on Land, Infrastructure, Transport and Tourism has also reported an increase in the probability of significant earthquakes occurring. For the Nankai Trough earthquake, the probability of an earthquake with a magnitude of 8 to 9 occurring within the next 30 years is estimated to be 70 to 80%. At Hotron, we recommend the introduction of seismic devices for earthquake measures in buildings and equipment. The seismic device 'HK-2' is a product that automatically performs various controls that have been pre-set when it detects strong shaking equivalent to a seismic intensity of 5 lower or higher. For example, it can automatically execute actions such as: "Open automatic doors and gates to secure evacuation routes and access for emergency vehicles" "Transmit signals to the control room and stop facility equipment" "Unlock the keys to locked lockers" "Automatically play voice guidance" ◎ For more details, please download the materials or contact us.

● To determine the sealing and waterproofing of sealed products based on pressure changes, it is not necessary to conduct tests that involve spraying water on the product or immersing it in water. ● Once the product is placed in a dedicated fixture within the inspection device, waterproofing can be quantitatively confirmed through automatic measurement. ● The target product size is W 300 × D 210 × H 100 mm or smaller. ● The target products include automotive cameras, smartphones, ECUs, small motors, and other packaging containers, and are effective for any products that require confirmation of sealing, waterproofing, and airtightness. ● For product specifications and details, please contact us.

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.