Electronic Device History Record (eDHR) Software

MasterControl's eDHR software automates the DHR process. It provides greater control of manufacturing data and documentation and a seamless connection between production and quality.

Integrated eDHR software delivers improved efficiencies and insights needed by medical device manufacturers. It streamlines and error-proofs their DHR processes and documentation, and it helps ensure quality during production.

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MasterControl eDHR Toolkit for Medical Device Firms

eDHR Software Benefits for Medical Device Manufacturers

Manufacturers around the world rely on MasterControl to help them automate their processes to deliver the highest quality medical devices faster.

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Improve efficiencies, traceability and compliance with eDHR software.

Efficient, Accurate DHR Processes

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Remove paper DHRs from the shop floor to streamline and error-proof the production record process, eliminating common DHR mistakes such as missing or incomplete documentation. MasterControl's eDHR software quickly and correctly captures and maintains all device history data, so products can be shipped sooner.

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Greater Visibility and Traceability

Get a real-time view of manufacturing operations and processes, including employee training and quality events. MasterControl eDHR software provides a complete record of the entire production life cycle, so you can easily identify nonconforming materials, their source and where they were used.

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Proactive Quality and Compliance

MasterControl's electronic production record software performs automatic data integrity checks and enforces training in real time. FDA-compliant, time-stamped audit trails, reporting and e-signature capabilities help ensure DHRs are always complete, errorless and compliant.

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Manufacturing Excellence

MasterControl's eDHR software is delivered as part of the MasterControl Manufacturing Excellence™ solution. The solution also includes tools to manage electronic batch records (EBR), equipment calibration and maintenance, and recipe and variant changes.

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