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  4. The clinical trial/quality document management cloud system 'Agatha' has obtained the JIIMA 'Electronic Document Software Legal Requirements Certification'.
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  • Aug 30, 2024
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Aug 30, 2024

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

アガサ アガサ
Agatha Corporation (Headquarters: Chuo-ku, Tokyo, President: Chiemi Kamakura, hereinafter referred to as "the Company") is pleased to announce that it has obtained "Electronic Document Software Legal Requirements Certification" from the Japan Document Information Management Association (hereinafter referred to as "JIIMA") for its clinical trial/quality document management cloud system "Agatha Basic" (hereinafter referred to as "Agatha"), in accordance with the Act on Special Provisions for the Preservation of National Tax-Related Books and Documents Created Using Electronic Computers (hereinafter referred to as "Electronic Book Preservation Act"). With the acquisition of the "Electronic Document Software Legal Requirements Certification," it is now possible to electronically preserve transaction-related documents such as contracts, invoices, and receipts using "Agatha" in compliance with the Electronic Book Preservation Act. With this certification from JIIMA, "Agatha" has been recognized for its suitability under the Electronic Book Preservation Act. For more details, please check the following URL: https://www.agathalife.com/news/jiima_20240828/
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Clinical Trial / Quality Document Management Cloud System 'Agatha' Obtains JIIMA 'Electronic Document Software Legal Requirement Certification' - Invoice Management in the Administration Department Can Also Be Centralized with 'Agatha' - Corporate Site

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Cloud-based document management system "Agatha Basic"

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

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Easily manage quality events and documents in the cloud | Agatha QMS

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

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Simple cloud-based SOP management and training records | Agatha SOP

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.

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Cloud-based document management system 'Agatha eTMF'

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.

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Cloud-based document management system "Agatha eTMF"

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Cloud-based Clinical Trial Document Management System "Agatha Facility Document Storage + IRB"

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Cloud-based document management and quality management system "Agatha QMS"

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Fukuda's leak test, leak inspection, leak detection, leak test, integrity test.

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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)

Feb 20, 2026

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Specializing in screw loosening prevention processing, "Tōkai Lock Co., Ltd." has had a strong start two months after opening!

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Tokai Rock, a group company of Koyama Co., Ltd. located in Numazu City, Shizuoka Prefecture, relocated its headquarters and factory at the end of last year and is now operating at full capacity with new equipment. At Tokai Rock, we protect our customers' screws from "loosening" and "deflection" over time by applying adhesive to the screw parts. We accommodate small lots, a variety of products, and short delivery times. Additionally, as a certified factory of the major adhesive manufacturer Henkel, we provide comprehensive support for environmental surveys and material certifications. Please feel free to contact the Development Sales Department of Koyama Co., Ltd. at ☎03 (3363) 3711.

Feb 20, 2026

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Announcement of the Opening of the Kyushu Sales Office by BM Nagano Co., Ltd.

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We are pleased to announce the establishment of the "Kyushu Sales Office" aimed at strengthening our business foundation in the Kyushu area. With the opening of the new sales office, we will be able to respond more quickly and flexibly to our customers in the Kyushu region, while enhancing our support system that is closely connected to the local community. We will also deepen our collaboration with local partner companies, aiming for further growth of our business while strengthening our trust relationship with the community. We kindly ask for your continued support for the Kyushu Sales Office and our company. Thank you very much. 【Kyushu Sales Office Overview】 Establishment Date: January 1, 2026 Company Name: BM Nagano Co., Ltd. Kyushu Sales Office Location: 1-15-20 Hakataekimae, Hakata Ward, Fukuoka City, Fukuoka Prefecture, 812-0011, NMF Hakataekimae Building 2nd Floor

Feb 20, 2026

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Underwater Robot ROV "MOGOOL" FAQ Released: Customization and Repair System, etc.

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JOHNAN Corporation has added a "Frequently Asked Questions (FAQ)" section to the webpage for its underwater drone "MOGOOL Series." ■ Topics Covered Customization and Contract Development: Support for specialized work applications beyond standard models Promotion of Underwater DX: Addressing the shortage of divers and achieving safe and efficient inspections Rapid After-Sales Service: Details of maintenance and repair systems through domestic bases We address the concerns of those considering the automation and labor-saving of underwater work, such as inspections of offshore wind power facilities and reducing the burden on divers. We also accept custom consultations from the conceptual stage.

Feb 20, 2026

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Catalog Update: Capsule Filter Products

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Immediately usable Donaldson capsule filters We have updated the catalog for three products. - PTFE capsule filter - PES capsule filter - PP capsule filter For more details, please check the link URL.

Feb 20, 2026

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  • 展示会に出展したいけど準備が大変 展示会の情報をまとめて知りたい そんな展示会のお悩み展サポ(R)で解決! ブース装飾で実績豊富 展示会情報を多数掲載 出展前~後まで支援
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