Missing or poorly compiled device history record (DHR) documentation can quickly derail your product’s path to market. An electronic device history record (eDHR) allows device companies to centrally collect and maintain all of the records required by the FDA’s Quality System Regulation (21 CFR Part 820) to document the production of each batch, unit or lot of a finished device. By automating your device history record processes with eDHR software, you can more confidently achieve compliance with FDA cGMP requirements, reduce risk and get to market faster than with a paper-based system.
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An eDHR demonstrates a device has been produced in accordance with its device master record (DMR). To do so, 21 CFR Part 820 requires that each DHR include, or refer to the location of, key pieces of information:
A paper-based or hybrid system is prone to errors. Information is captured and stored in disparate systems. With an eDHR software system, all critical information is stored in a central location. Easily manage data inputs from different sources and personnel.
An eDHR software solution can digitally integrate with a quality management system (QMS) to provide real-time nonconformance- and deviation-tracking tools. Quickly identify quality events and allow corrective action to ensure in-line quality assurance without interruption. Automatically storing eDHRs in a QMS eliminates manual routing of paper records from the shop floor to the quality department.
Paper-based DHR processes are slow, cumbersome and inefficient. Even so, medical device manufacturers continue to rely on these manual systems. The result is expensive delays in delivering life-saving or life-improving products. It also increases the risk of quality issues, warning letters or product recalls. eDHR software is the solution to these problems.
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