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Manufacturing

Electronic Device History Record (eDHR) Software

Leverage an eDHR Software for Streamlined Compliance

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.

Manufacturing Quality: Frictionless Quality and Compliance With eDHR
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What is an electronic device history record (eDHR)?

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:

  • Dates of manufacture.

  • Quantity manufactured.

  • Quantity released for distribution.

  • Acceptance records which demonstrate the device is manufactured in accordance with the DMR.

  • Primary identification label and labeling used for each production unit.

  • Unique device identifiers (UDI) or other control numbers for each batch, lot or unit that a device company produces.

  • Return material authorization (RMA), returns and repairs.

  • Complaints and DMR change management.

Store critical information in a central location.

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.

Quality assurance without interrpution.

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.

Why Paperless Is Better

01

Centralized storage improves audit-readiness.

02

Enforce data limits and training.

03

Address quality issues.

04

Leverage multi-user technology.

Avoid costly delays and quality issues.

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.

Confidently achieve compliance.

Leverage eDHR software to ensure you get to market quickly while reducing risk.

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