Natural Ingredients and Products Directory is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Electronic Device History Record (eDHR) Software Systems

Electronic Device History Record (eDHR) Software Systems

Electronic Device History Record (eDHR) Software Systems Electronic Device History Record (eDHR) Software Systems by MasterControl Automates Electronic Device History Records and Electronic Device Master Records (eDMR) to Comply with 21 CFR Part 820 and 21 CFR Part 11 The FDA's Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to establish and maintain device history records for each batch, lot, and unit they produce. The eDHR software is a compilation of all records pertaining to the production of a finished medical device. It entails extensive documentation that includes dates of manufacture, quantity manufactured and when they were released, acceptance records to show that the device was produced according to device master records (DMR), identification labeling, and device identification and lot numbers.

View this product at mastercontrol.com
Feedback