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.
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basic information
▼Features of Agatha Basic ● Equipped with basic functions that comply with regulatory requirements ● Ability to freely create workspaces and folders ● Unprecedented low price ● Simple UI focused on intuitiveness that anyone can use ● Supports Japanese and English ● Quick implementation - as needed, when needed ▼Basic Functions ● Document viewing ● Document disposal & restoration ● Search (documents/full text) ● Filtering ● Document sharing ● Hyperlink acquisition ● Change history recording ● Audit trail recording ● Document version management ● Display changes (list/by person)
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For more details, please refer to the PDF document or feel free to contact us.
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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.