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Cloud-based document management system Product List

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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.

  • File Management
  • Cloud-based document management system

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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
  • Cloud-based document management system

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Reduction of on-site document search time and decrease in errors: Example of utilizing a document management system.

For shipbuilding and heavy machinery manufacturers. A case where drawings, inspection records, and photos of large projects were centrally managed with tags, achieving shared control among multiple companies and strengthening BCP (Business Continuity Planning).

We would like to introduce a case study of our "necfru drive" implementation at Shipbuilding and Heavy Machinery Manufacturer Company I. The company faced challenges due to the vast amount of documentation generated over long-term large projects, as well as difficulties in managing the sharing scope due to the involvement of many partner companies. To address this, they designed tags for projects, blocks, processes, and part numbers, and implemented limited public sharing via URL with role-based permission settings for partner companies. As a result, the time spent searching for documents on-site has been reduced, and the risks associated with misconfigurations in the sharing scope have also been minimized. [Case Overview (Partial)] ■ Challenges - Inability to find necessary documents on-site leading to rework - Limitations on expanding on-premises capacity and maintenance burden ■ Response - Completed blocks were moved to a COLD area to optimize capacity - Gradual migration from important folders to stabilize operations \Helpful materials are currently available/ *For more details, please download the PDF or feel free to contact us.

  • Storage Backup
  • Cloud-based document management system

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