eDHR Software Systems

eDHR Software Systems

MasterControl's electronic device history record (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.

MasterControl eDHR™ Toolkit for Medical Device Firms

Improve efficiencies, traceability and compliance with eDHR software.


Efficient, Accurate DHR Processes

Laptop with blue ring binders stacked on

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.


Greater Visibility and Traceability

Manufacturing shop floor

Get a real-time view of manufacturing operations and processes, including employee training and quality events. MasterControl DHR 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.


Proactive Quality and Compliance


MasterControl's 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.


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.

Trusted By


Comprehensive DHR Management

Relying on paper-based DHR processes exposes manufacturers to unnecessary risks. These risks make it difficult, if not impossible, to ship products fast while complying with regulatory demands. MasterControl's eDHR software provides all the tools a medical device manufacturer needs to avoid these risks and gain total control of DHRs. 

Two factory workers talking and using a tablet

Quality Built Into Production

MasterControl's digital manufacturing software helps improve plant operations and product quality. Building quality into the production process with MasterControl eDHR™ results in fewer deviations and production errors.

Take control of your device history records.

Don't let manual, paper-based DHR processes get in the way of your smart manufacturing efforts.

Download the Data Sheet