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.
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▼Recommended for those who: ● Want to centralize and streamline the management of quality event information occurring in various business processes ● Wish to share and manage information with other facilities, departments, and external parties on the cloud, transcending location and time constraints ● Want to manage the progress and trend analysis of quality event information within a system ● Aim to establish a system that allows for the speedy submission of necessary documents during audits and inspections ● Want to strictly adhere to deadlines and shorten the cycle time of quality processes ● Wish to conduct event management linked with SOP and document management information ▼Features of Agatha ● Available for use worldwide (compliance with various laws and multilingual support) ● Total support provided from implementation to post-operation ● Extensive implementation experience not only in corporations but also in medical institutions ● Over 2,000 organizations have used it (with experience in FDA inspections) ● Implementation support including validation assistance ● Agatha Quality Solution lineup: Agatha Basic/Agatha SOP/Agatha QMS *For more details, please refer to the PDF materials or feel free to contact us.
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【Purpose】 ■For life science companies *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.