The electronicization of GxP documents in pharmaceutical companies and the expansion of electronic exchanges between medical institutions and pharmaceutical companies!
In this document, we summarize and introduce case studies of Agatha Inc.'s cloud-based document management system "Agatha." We present five case studies, including responses to FDA inspections, transitions from foreign systems, and a project to centralize events across approximately 10 factories. Each case includes the challenges faced and comments from users. This is a valuable resource, so please take a moment to read it. 【Featured Case Studies】 ■ Response to FDA inspections using Agatha ■ Implementation in both the medical device and pharmaceutical sectors ■ Case studies of transitions from foreign systems ■ Centralization project for events across approximately 10 factories ■ Implementation of Agatha QMS and SOP both domestically and internationally *For more details, please download the PDF 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.