Electronic Device History Record (eDHR) Software Systems

Automate the Device History Record (DHR) Process for Greater Control of Manufacturing Data and Documentation.

The U.S. Food and Drug Administration’s (FDA) Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to fully and accurately maintain DHRs for every product batch, lot and unit. The DHR process entails extensive documentation of dates of manufacture, quantity manufactured and released for distribution, identification labeling and more. A robust eDHR software system will compile all data and documentation pertaining to the production and postmarket control of finished medical devices.

MasterControl Electronic Batch Records™ (EBR)