Regardless of a medical device’s potential to save lives or improve health, missing or poorly compiled device history record 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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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 it include documented evidence – or point to the specific location – of the dates of manufacture, the quantity manufactured, the quantity released for distribution, acceptance records, labeling information, and unique device identifiers (UDI) or other control numbers for each batch, lot or unit that a device company produces.
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 not only inefficient and error prone, but they also make it difficult to keep pace with changing technologies and increasing quality and traceability requirements.
An eDHR 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:
Find more information about electronic device history record (eDHR), please visit MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.