Electronic Device History Record (eDHR)

Device History Records (DHR) serve as the production record for the manufactured medical devices and are comprised of production travelers, standard operating procedures (SOPs) and other documentation. A robust eDHR software system will compile all data and documentation pertaining to the production and postmarket control of finished medical devices.

DHR Challenges


MasterControl Advantages

Inefficient, Error-Prone Processes
DHR processes conducted manually are inherently slow, cumbersome and prone to errors such as incomplete data fields or mismarks. As DHRs grow both in size and complexity, they require more time to prepare and review, and often cause delays in product shipment.

Efficient, Accurate Processes
MasterControl streamlines and error-proofs the DHR process, eliminating common production mistakes such as missing or incomplete documentation. MasterControl efficiently and accurately captures and maintains all device history data, so products can be shipped quicker.

Limited Visibility and Traceability
A manual DHR system makes tracking logs, test results and other records from different departments difficult. Limited visibility into manufacturing operations and insufficient tracking across the production processes significantly increases the occurrence of bottlenecks, a critical problem if defective batches need to be identified.

Greater Visibility and Traceability
MasterControl provides real-time visibility and traceability into manufacturing operations and processes, including employee training and quality events. A complete, centralized record of the entire production process lets manufacturers easily identify non-conforming materials, their source and in which lots they were used.

Disconnected Systems
In a manual, paper-based or partially electronic DHR system, device history data is often kept in disconnected repositories, which makes reporting, trending and analysis difficult. And because most manual systems don’t connect with other quality processes, continuous improvement is almost impossible.

Connected Processes
MasterControl allows connectivity with other applications that control different processes, ultimately connecting critical manufacturing and quality processes to one another. For example, production data can be correlated to deviations, material nonconformances and customer complaints.

Quality and Compliance Risks
Paper-based DHRs filled out by hand often contain incomplete or illegible data, which makes it difficult to maintain an audit-ready archive of DHR data and documents. Should an FDA inspection occur, having to sift through folders and filing cabinets of paper records causes delays and headaches, increasing the risk of not meeting quality and compliance requirements.

Proactive Quality and Compliance
MasterControl enables manufacturers to proactively meet quality and compliance requirements. It performs automatic data integrity checks, allows immediate access to collected data and includes comprehensive record retention functionality with FDA-compliant, time-stamped audit trails, reporting and e-signature capabilities.

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