eDHRElectronic Device History Record
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The IIoT enables all data to be stored for the eDHR and makes this report readily available for review by customers or auditors.
Furthermore, this same eDHR implemented in the MES allows immediate navigation into related reports or more detailed information from within the same system.
Beyond the eDHR, several other CFR21 requirements are significantly easier to comply with if implemented in a common shopfloor platform.
Our real-time eDHR solution gives medical device manufacturers a cost-effective way to meet the FDA's requirements for quality and product and process traceability," said Joe Bellini, senior vice president of Brooks Software.
The real-time eDHR solution provides serialized component- level tracking and traceability and gives complete visibility to the As-Built Configurations (ABC) as well as the current status of all WIP on the shop floor.
In fact, eDHR solutions provide current status of work in process on the shop floor while taking into account human factors to greatly reduce processing errors.
An eDHR allows manufacturers to capture "as-built manufacturing information" in real-time, ensuring operators are adhering to the specified device configuration and providing manufacturing audit trails for compliance.
eDHR Intelligence leverages Medical Device manufacturers' investment in the SAP platform by providing an out-of-the-box application built on the NetWeaver and xMII platform, which are the preferred SAP solutions for interoperability and intelligence for manufacturing.
Camstar Systems, Inc, a leading provider of Enterprise Manufacturing and Quality Systems and an SAP[R] Software Partner, announced today that its eDHR Intelligence(TM) version 4.
The eDHR Intelligence solution integrates Camstar's best-in-class Manufacturing and Quality Execution solution with the SAP ERP application to address the unique challenges facing the Medical Device industry around risk mitigation, product/process complexity management and cost reduction.
Camstar's Rapid eDHR to Accelerate Time to Compliance and Quality
By lowering the total cost of ownership of manufacturing systems for the small to mid-sized business (SMB) marketplace, Camstar's Rapid eDHR allows these manufacturers to use the same proven approach to reduce their costs of compliance and improve quality.