Electronic Device History Record (eDHR)
Regardless of a medical device’s potential to save lives or improve health, 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 an eDHR, 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)?
The purpose of an eDHR is to demonstrate that 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; and
- Complaints and DMR change management.
These records, comprised of production travelers, SOPs and other documentation, require inputs from many workers, inputs which are often captured and stored in disparate systems that are managed by different departments or even different sites. Combined with the fact that all data entries and sign-offs must be formatted in a compliant manner, maintaining a complete and orderly device history record can be an inefficient and cumbersome process rife with errors, particularly if you are using a paper-based or hybrid system. Manual device history record practices are inefficient and error-prone, and they make it difficult to keep pace with changing technologies and shifting quality and traceability requirements.
How can an electronic device history record system benefit you?
An eDHR system allows you to centrally and efficiently manage data inputs from many different sources and personnel, and ensure that the data is complete and collected in the correct format at the time it is entered. Additionally, an eDHR makes detecting the source of deviations and responding to product recalls much faster and less resource intensive. All of this means you can get to market faster while saving money and reducing risk.
Centralizing and automating your device history record systems with an eDHR can help you to:
- Streamline the audit process. All device history data is captured, compiled and stored electronically in one central repository, including any external files, which greatly improves your inspection readiness and provides auditors with a complete and orderly DHR.
- Proactively reduce the risk of quality events. Take advantage of predictive analytics and advanced reporting capabilities to identify and help prevent future bottlenecks, address CAPAs and deviations, and ultimately achieve products that are made right the first time.
- Verify data formatting in real time. Each field can automatically check that data is entered in the correct format and alert users to any errors so that they can be addressed on the spot, significantly reducing data entry times.
- Quickly gain an overview of missing information. In a centralized system, you can easily see if data is missing, incomplete, inconsistent or incorrectly formatted.
- Improve traceability and minimize the scope of product recalls. With a complete and central record of the entire production process, you can easily identify any non-conforming materials, their source and in which lots they were used, and address quality issues with minimal impact to public safety and your operations.
- Monitor and enforce training automatically. As workers enter data into an eDHR, the system can simultaneously track their training record to ensure they are qualified to perform and sign off on a given task.
- Improve collaboration between teams and sites. With a common tool, manufacturing and quality teams that are separated by geographical or departmental boundaries can collaborate and communicate more efficiently.
- Leverage multi-user technology. When more than one person can work in the system at the same time, actions like task verification and witnessing, data corrections, QA review, and launching deviations can be performed simultaneously.
Learn More About Electronic Device History Record (eDHR) Systems
To learn more about MasterControl’s electronic device history record and device master record software, please contact a MasterControl representative.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
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To learn more about MasterControl's software systems, please contact a MasterControl representative.
