Significantly improve operational efficiency through total management of quality-related tasks!
■Customers can configure reports Flexibly respond to modifications of flows and revisions of reports due to changes in existing operations. It is possible to lead the digitization of various operations beyond just QMS operations in-house. ■New feature [Management of Manufacturing Record Issuance] is here! Utilizing the existing document management function, it achieves management of the latest version/history (original document management). Management and operation can be done by the system without human intervention from request to printing. Electronic reports are utilized and operated with "Quality Designer for GxP." Records are kept as audit trails.
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basic information
●Quality management system for the pharmaceutical and medical device industry "Quality Designer for GxP" Operates change management, complaint management, CAPA management, etc. using electronic forms. Ensures data integrity. Enables secondary utilization of information analysis through centralized management.
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Applications/Examples of results
【Six Usable Business Examples】 - Change Management: Consistently manage progress from application to consideration, implementation, and completion. By implementing changes for multiple products collectively, it can be managed without omissions. - Quality Information: Manage the entire process from reporting to instructions and completion of responses in a consolidated manner. It includes necessary task management for collaboration with related departments and medical institutions. - Deviation Management: Flexibly respond to operations based on procedures suited to the situation from the occurrence of deviations to prevention of recurrence. - CAPA Management: Consistently operate "corrective actions" for issues that arise and "preventive actions" for matters that may pose a risk of problems. - Document Management: Operate the registration, revision, and abolition of documents through a workflow. Controlled execution of operations allows for collaboration with other tasks such as training and education. - Training and Education: Manage from planning to reporting. It automatically links during document registration and revision. It allows for consolidated management of participant reports, ensuring no omissions or delays.
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Company information
Our company was founded in 2001 and provides practical consulting to support improvement activities in manufacturing, such as revenue enhancement, productivity improvement, lead time reduction, and inventory reduction, including the introduction of DX systems. Based on our unique production management method, the "One-Piece Flow Production System," we create customized original programs tailored to each company's management challenges, addressing everything from "on-site improvements" to "system improvements" and "production innovation," and provide appropriate solutions. If you encounter any issues that need to be addressed, please feel free to contact us. We will definitely provide solutions that satisfy your company. [Astech Consulting HP] https://www.ast-c.co.jp/
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