Medical Devices • March 25, 2015

What is an Electronic Device Record?

iBase-t Experts

eDHRThe term eDHR – electronic device history record – is being thrown around a lot these days.  But what exactly is an eDHR?  Originally created for medical device and diagnostics manufacturing for the purpose of keeping record of the products produced, the device history record was a paper document that traveled with the product shipment or stored as paper records at the manufacturer’s site.  With the introduction of electronic manufacturing and quality systems, the formally paper document, can now be created, stored, and delivered electronically; hence, the eDHR.   So, what exactly makes up an eDHR?

The eDHR is used as a management tool to ensure the manufacturing process has been followed, that the components and materials authorized for assembly into the product were, in fact consumed, that all the data and validation activities have passed, and ensures compliance for both the product and the workers assembling it.  While there is no template or mandatory criteria that goes into an eDHR, the purpose is clear.  If something were to go wrong on a product, can we use the eDHR to track what happened?  This very purpose is why the eDHR is now moving to other types of manufacturing including aerospace.

Let’s think about all the information that could make up the eDHR content; Part information, Bills of Material, Supplier and Purchase Order information, lot numbers, serial numbers, inspection and test results, non-conformances, document revisions, electronic signatures, and tools used during assembly, just to name a few.  Now, think about if one had to gather all this information across multiple systems for every single product manufactured.  Now, if it’s a simple product, it wouldn’t be too bad, but we work in a world where there is lots of complexity, so, having to gather this information could take multiple full time employees.

The easiest way to create and manage an eDHR is to have all eDHR information in one system.  Having a manufacturing system that provides all the tools and functions needed to support consistent manufacturing processes, built in quality control, outreach to the supplier base, and change management facilitation brings the eDHR back to it’s original pupose; an output report.

When taking the plunge from the paper to and electronic Device History Record, be sure that you can get just that with your new electronic system – a report.

Explore iBase-t solutions for medical device manufacturers; view our brochure.

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