6 Essential Capabilities Of A Complete eDHR System

By Brian Curran, Senior VP of Strategic Growth, MasterControl

While many manufacturers in medical technology manufacturing think they have an electronic device history record (eDHR) system, often it is incomplete because it still relies at least in part on paper. Even when manufacturers have automated core parts of their manufacturing, critical production processes like the DHR are still paper based or disconnected.

Examples of incomplete eDHR software systems include islands of automation or app-like manufacturing execution system (MES) tools, both of which require printing the digital portion from the systems and merging that paper with the paper-based records from the rest of the production process to create complete DHRs. A legacy MES can also be an incomplete eDHR system, because all production capacity that isn't automated using the MES often still has paper-based DHRs.

Whereas an incomplete eDHR system offers insufficient visibility, traceability, and data integrity, a complete eDHR solution enables smarter, faster manufacturing processes, so medtech manufacturers can make immediate performance gains at every step. In this blog we share tips on how to implement a complete, end-to-end eDHR system that allows you to capture and leverage all the data needed to optimize production while ensuring compliance with FDA 21 CFR Part 820 requirements.