DHF & DMR Management
Dynamic DHF & DMR Management
Capturing changes to the Design History File (DHF) and the Device Master Record (DMR) inside your Product Record is necessary to demonstrate the entire design history of your device to the regulatory bodies. This is often a task that is associated with manual, tedious work and a high risk of errors.
The DHF and DMR management capability in Minerva PLM Powered by Aras allows you to create as many regulatory structures you need and have them managed in the same way so that they are automatically created, tracked, and baselined.
With consistent information available in one place and faster documentation retrieval, you are able to face audits with confidence.
Accuracy & traceability across projects
With DHF and DMR Management, you don’t have to waste time locating project information. You can easily store and retrieve all documentation for the projects in Design History File & Device Master Records file folders which are automatically created. A version of the DHF and DMR exist for every revision of the project.
Templates can be constructed with the wanted structures for the DHF and DMR and then added to projects. The Minerva PLM Powered by Aras can be configured to also contain structures and templates for other file folders than DHF and DMR, like the technical file.
Accurate project update status
Capture product data changes in real-time as they happen, not as an afterthought
Efficient regulatory submission workflow that is futureproofed
Decreased risk of errors and improved product quality and support with the ability to rapidly respond to changing customer demands
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