The FDA's Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to establish and maintain device history records for each batch, lot and unit they produce. The eDHR software is a compilation of all records pertaining to the production and postmarket control of a finished medical device. It entails extensive documentation that includes dates of manufacture, quantity manufactured and when they were released, acceptance records to show that the device was produced according to device master records (DMR), identification labeling, post-sale alterations and corrections, and device identification and lot numbers.
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The continued reliance on paper-based processes and legacy systems to manage DHRs makes it difficult, if not impossible, to comply with a shifting regulatory landscape. Many medical device manufacturers with such systems face poor data capture and other common challenges when it comes to complying with the FDA’s DHR requirements, often leading to incorrect analysis and decisions that inadvertently have a negative effect the state of the business. Common DHR challenges include:
It is extremely important to have a comprehensive system that can completely collect and control all the eDHR data and documentation that is critical for compliance.
MasterControl’s Manufacturing Excellence suite provides an online platform for designing, managing and controlling device history record files that are dependent on inputs from several sources. MasterControl eDHR software connects standard operating processes, training, inputs, specifications, change control, quality events and traceability.
MasterControl Manufacturing Excellence automates the eDHR system to make an inefficient and error-prone manual process more efficient, enabling medical device companies to maintain centralized, electronic records of proper handling for every major step in producing a product. Problems like incomplete or missing documents, illegible data entry and similar inefficiencies become a thing of the past.
MasterControl Manufacturing Excellence contains all the tools medical device organizations need to gain control of their DHRs:
MasterControl eDHR software systems allow companies to take advantage of advanced analytics and customizable reports. Eventually, companies are not only able to attain but also sustain compliance that is based on connectivity and cross-collaboration between users and processes across the enterprise.
To learn more about MasterControl’s eDHR system, contact a MasterControl representative.