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

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

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last updated:Jul 12, 2024

アガサ
アガサ
  • Official site

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
ipros_20240722メルマガ.png

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

ipros_20240722メルマガ.png
ipros_20240722メルマガ.png
  • Related Link - https://go.2.agathalife.com/l/1014252/2024-07-11/3…

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▼Features of Agatha SOP ● Compliance with various regulations for the pharmaceutical and medical device industries ● Various functions specialized for SOP management ● SOPs are automatically distributed to designated "training recipients" after approval is completed ● If the comprehension test is failed, a retest can be automatically sent ● Training records can be viewed and output from various perspectives ● Support service for CSV (PQ) implementation available ▼Common Features (Excerpt) ● Template forms ● Document viewing ● Document disposal & restoration ● Search (documents/full text) ● Filtering ● Document sharing ● Hyperlink acquisition ● Change history recording ● Audit trail recording ● Document version management *For more details, please refer to the PDF materials or feel free to contact us.

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Cloud-based SOP Management System "Agatha SOP"

Cloud-based SOP Management System "Agatha SOP"

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The clinical trial and research document management cloud service 'Agatha' has been awarded 29th place in the 'Technology Fast 50 Japan'.

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Agatha Co., Ltd. (Headquarters: Chuo-ku, Tokyo, President and CEO: Chiemi Kamakura, hereinafter referred to as "the Company") recorded a growth rate of 175% based on revenue over the past three fiscal periods in the ranking "Technology Fast 50 2024 Japan," announced by the Deloitte Tohmatsu Group, and was awarded 29th place. The Company received the 29th place award at the ranking announcement and award ceremony for "Technology Fast 50 2024 Japan," held on January 22, 2025 (Wednesday). *List of award-winning companies for Technology Fast 50 2024 Japan https://www2.deloitte.com/jp/ja/pages/about-deloitte/articles/news-releases/nr20250122.html For more details, please check the following URL. https://www.agathalife.com/news/tf50_250124/

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Chieko Kamakura, representative of Agatha, which provides a cloud system for clinical trials and quality document management, has won the Nikkei WOMAN "Woman of the Year 2025"!

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- Recognized for promoting DX (digital transformation) in the medical field and selected as a role model for working women - Agatha Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President: Chieko Kamakura; hereinafter referred to as "the Company") is pleased to announce that President Chieko Kamakura has received the "Woman of the Year 2025" award, presented by the information magazine "Nikkei WOMAN," which honors women who have made remarkable achievements in various fields. The award ceremony for "Woman of the Year 2025" took place during the "WOMAN EXPO 2024 Winter" held on November 30, 2024, where a total of nine individuals, including our representative Chieko Kamakura, were selected. For more details, please check the following URL: https://www.agathalife.com/news/woy-20241205/

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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!

  • Company news

- Recognized for performance growth, awarded a certificate and commemorative trophy - Agatha Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President: Chiemi Kamakura; hereinafter referred to as "the Company") is pleased to announce that President Chiemi Kamakura has received the 【Sustained Growth Category】 at the 5th "Tokyo Woman CEO Award," which honors female executives with outstanding achievements in various fields and growth stages in Tokyo. The award ceremony for the 5th "Tokyo Woman CEO Award" was held during the "7th NEW CONFERENCE for the Advancement of Female Executives," which took place on November 25, 2024. Our representative, Chiemi Kamakura, was awarded in the 【Sustained Growth Category】. At this award ceremony, certificates and commemorative trophies were presented to two recipients in the 【Sustained Growth Category】 and the 【Sustainable Management Category】. For more details, please check the following URL: https://www.agathalife.com/news/twea_241203/

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

  • Product news

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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Our company provides a cloud service for creating, sharing, and storing documents related to clinical trials and clinical research on a project basis for medical institutions, pharmaceutical companies, medical device companies, CROs, SMOs, clinical testing companies, and more. In addition to offering systems specialized for the medical and life sciences industries, we provide comprehensive support from implementation to operation by staff with expertise in the medical field. Please feel free to contact us if you have any inquiries.

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