Manufacturing
Electronic Device History Record (eDHR) Software
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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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:
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Dates of manufacture.
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Quantity manufactured.
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Quantity released for distribution.
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Acceptance records which demonstrate the device is manufactured in accordance with the DMR.
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Primary identification label and labeling used for each production unit.
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Unique device identifiers (UDI) or other control numbers for each batch, lot or unit that a device company produces.
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Return material authorization (RMA), returns and repairs.
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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 interruption.
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
Centralized storage improves audit-readiness.
Device history data is captured, compiled and stored in a central location. This includes relevant external files. Everything can be accessed quickly and easily, which improves inspection readiness. Ensure data entries and sign-offs are formatted in a compliant manner. Leverage an eDHR software system to provide auditors with complete and orderly DHRs.
Enforce data limits and training.
Each field can automatically check that data is entered in the correct format. Users are alerted to any errors so they can be addressed in real-time. As workers enter data into an eDHR, the system tracks their training record to ensure they are qualified to perform and sign off on a given task.
Address quality issues.
With a complete, central record of the entire process, easily identify any non-conforming materials. This includes their source and in which lots they were used. Address quality issues with minimal impact.
Use predictive analytics and advanced reporting capabilities. You can prevent future bottlenecks, address CAPAs and deviations, and ultimately achieve right-first-time production.
Leverage multi-user technology.
More than one team or authorized person can work in the system at the same time. Manufacturing and quality teams in separate locations can easily communicate and collaborate. When more than one person can work in the system at the same time, actions can be performed simultaneously. This includes task verification and witnessing, data corrections, QA review and launching deviations.
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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