The Rapid Series

An electronic device history record (eDHR) allows manufacturers to collect and manage critical records required by the FDA to document the production of each device. By automating your device history record processes with an eDHR, you can more confidently achieve compliance with FDA cGMP requirements, reduce risk, while enhancing safety for medical device users. By bringing together all data about a device’s manufacturing and testing history, the eDHR tracks data to ensure the documented manufacturing process was followed, and ensure compliance. That includes the requirement that the components and materials approved for assembly into the product were the ones actually used, all tests passed, and that all workers involved in the manufacturing and testing processes were trained and certified on the required operations.

Some manufacturers have been slow to move from manual record keeping processes due to the degree of difficulty and the length of time involved in implementing eDHRs. 42Q has dramatically changed that equation with the Rapid eDHR solution, a Cloud-based platform that provides 21-CFR Part 11 compliance, supports employee validation in the manufacturing and testing processes, and provides enforced compliance in highly regulated manufacturing environments – all in just a few weeks.