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

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.

  • Document and Data Management

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[Webinar On-Demand] Innovation through the Use of Generative AI

[Webinar On-Demand] Innovation through the Use of Generative AI

Agatha × Generative AI: Innovation in Clinical Trial Procedures, Document Creation, and Document Management through the Utilization of Generative AI.

You can watch the video of the webinar held in April 2024. In addition to introducing the Agatha solutions deployed in the GCP area, we will present case studies from companies that have actually implemented them, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also introduce examples of utilizing TMF Metrix evaluation using reporting tools. We encourage you to participate and hope it will help you address your company's challenges.

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[On-Demand Webinar] About Cultivating a Quality Culture

[On-Demand Webinar] About Cultivating a Quality Culture

【Tokyo University of Science, Professor Suzuki's Presentation!】About Cultivating a Quality Culture

You can watch the video of the webinar held on February 14, 2024. In addition to introducing the Agatha solution deployed in the GCP area, we will showcase case studies from companies that have actually implemented it, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also present examples of using the TMF Metrix evaluation with reporting tools. We encourage you to participate and hope it will help you address your company's challenges.

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Clinical Trial Document Management System - Case Study at Riverfield Inc.

Clinical Trial Document Management System - Case Study at Riverfield Inc.

Achieve efficiency and accuracy in operations with Agatha SOP and Agatha QMS!

We would like to introduce a case study on the implementation of "SOP Management and Training Records" and "Agatha QMS" at Riverfield Inc., which develops medical robots. At the company, operations were conducted using printed documents created in Word and an analog procedure of circulating approvals on paper. After the implementation, they have achieved greater efficiency and accuracy in their operations, and they have reported that urgent approvals can now be obtained in a very short time. [Utilized Operations] ■ Agatha SOP - Review and approval workflow for newly created or revised documents such as various regulations and forms - Implementation of training (Read & Review, confirmation tests) - Viewing of documents such as regulations and forms, and investigation of revision history ■ Agatha QMS - Management of nonconformities, complaint handling, and CAPA management in the QMS for medical devices *For more details, please download the PDF 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

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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治験関連文書をクラウドで管理｜Agatha施設文書保管+IRB

治験関連文書をクラウドで管理｜Agatha施設文書保管+IRB

利用実績2,500法人以上！治験・臨床研究文書をシンプルで手軽にペーパーレス化。初めてでも安心の、使いやすいクラウドサービス

Agatha施設文書保管+IRBは、治験・臨床研究の文書を、クラウド上で共有・保存・管理を一元化できる文書管理クラウドサービスです。 法規制に対応したセキュリティの高いシステムのため、紙の代わりに、電子ファイルのみで管理することができます。治験・臨床研究の大量の紙をなくし、ペーパーレス化を実現できます。 使い方はとてもシンプル。さらに安心のサポート体制で、分からないことがあってもすぐに素早く解決し、快適に利用できます。 ＜こんな方におすすめ＞ ● 文書の電子化・電磁化をし、働き方改革を進めたい方 ● 治験・臨床試験の紙の保管スペースに場所を取られてしまっている方 ● 紙の印刷、コピー、郵便や持ち運びに手間がかかっている方 ● 最新版が分からない・間違って上書きしたなどファイル管理が煩雑になっている方 ● 添付ファイルとパスワードを別で送る作業に煩わしさを感じている方 ● 治験責任医師や病院長で、出張先から文書の承認をしたい方 ※詳しくはPDF資料をご覧いただくか、お気軽にお問い合わせ下さい。

  • File Management

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Let's think about promoting the use of Central IRB for on-demand distribution.

Let's think about promoting the use of Central IRB for on-demand distribution.

Promoting the Use of Central IRB for Everyone: Digitization of Agatha Facility Document Storage and Utilizing Central IRB

You can watch the video of the webinar held on August 9, 2023. In addition to introducing the Agatha solutions deployed in the GCP area, we will present case studies from companies that have actually implemented them, as well as features utilizing generative AI that were recently announced in a press release, along with a demonstration. We will also introduce examples of utilizing TMF Metrix evaluation using reporting tools. We encourage you to participate and hope it will help you in solving your company's challenges.

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Cloud service "Agatha CTMS"

Cloud service "Agatha CTMS"

Introduction of the joint development project with A2 Healthcare Co., Ltd.! Features of the new version and future prospects.

Agatha Corporation is set to release a new version of its cloud service 'Agatha CTMS', which is easy to use even in advanced clinical trials. This service is designed to meet Japanese regulatory requirements while also being capable of supporting global trials, featuring both "simplicity" and "flexibility." It allows for the creation and management of monitoring reports for each trial via web forms, as well as the registration and management of issues, achieving centralized document management and visualization of information with a simple UI tailored to user needs. [Development Concept] ■ Triple A Project - Advancing (Evolution of Management) - Accelerating (Acceleration of Clinical Trials) - Achieving (For the Patients) *For more details, please download the PDF or feel free to contact us.

  • Document and Data Management

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