Version control for tracking the design development records and verification results of medical devices.
Even if a quality manual is established, isn't the basis for design changes still in the hands of individuals?
With the document management system "Digital Dolphins," you can organize the storage locations for design development plans, design verification records, and design change records by department, making it easier to trace the history of specifications. It links records to products and versions, facilitating access to the necessary documentation for conformity assessments and discussions on improved models. You can filter the required documents by attributes without relying on folder hierarchies, and adjust the scope of publication to fit business needs through permission and group settings. It also supports integration with existing systems (as an option or through individual arrangements) and can be used as a cross-departmental foundation spanning design, testing, and quality assurance. We provide support from operational design to implementation, along with document management consulting developed through over 25 years of 3S activities. Please feel free to contact us when you need assistance. *Also, please refer to the "Information Personalization and Handover Risk Checklist." *For more details, please download the PDF or feel free to contact us.
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basic information
【Features】 ■ Attribute Search: Narrow down necessary records by product name, model, applicable standards, and design change numbers. ■ Version Management: Keep a history as a series of the same document, making it easier to check the content before and after changes. ■ Relational Linking: Make it easier to trace from design specifications to verification records and risk analysis documents.
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You can utilize it for managing design development records in the design, testing, and quality assurance departments. For case studies and inquiries about operational design, please feel free to contact us.
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Company information
■Mold Manufacturing For 68 years since our founding, Hiraoka Alloy Tool Co., Ltd. has been dedicated to mold manufacturing with an indomitable challenger spirit. Rather than mechanically producing products requested by our customers, we actively propose solutions that better meet customer needs, enhance customer benefits, and contribute to customer cost reduction. http://www.sg-loy.co.jp/ ■3S Activities For over 17 years, we have been engaged in thorough 3S (Sort, Set in order, Shine) activities. To share the know-how of management innovation through 3S activities, we conduct factory tours, lectures, and speaking engagements. http://sg-loy.com/ ■Document Management System As a tool for the evolution of 3S from location and item management to "Information (Documents and Data) 3S," we have developed and are selling the document management system "Digital Dolphins." http://www.digitaldolphins.jp/
