MasterControl eMDR™ - Medical Device Reporting System Software

Software System for Electronic Automation of Medical Device Reporting - for FDA and Other Global Regulatory Environments

The FDA’s medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report to the FDA any deaths or serious injuries as well as certain malfunctions associated with their devices. MasterControl Inc. offers an electronic medical device reporting (eMDR) software solution that enables MasterControl users to implement their FDA adverse event reporting process electronically.

How can MasterControl eMDR™ Software System Benefit You for Medical Device Reporting?

The MasterControl eMDR solution module has been designed to meet the requirements for forms processes within the confines of FDA/GxP environments including compliance with 21 CFR Part 11. Here’s how MasterControl eMDR helps companies address challenges that are common to the implementation and management of MDR systems:

Medical Device Reporting Challenges		MasterControl eMDR™ Software System Solution for Medical Device Reporting
Disconnected Manual Medical Device Reporting Systems With paper systems, it is difficult to ensure that there is sufficient documentation of MDR decision-making processes.		Connected, Secure Medical Device Reporting Software System With MasterControl, all MDR event files are adequately documented and electronically maintained in a centralized, secure repository.
Slow, Inefficient Systems Reporting to FDA via traditional “snail mail” is slow and inefficient for both the FDA and the company reporting to the FDA, to such a degree that electronic reporting will be mandatory in the near future.		Electronic Medical Device Reporting System eMDR Reporting to FDA electronically is more efficient and saves time and resources. MasterControl’s automated system ensures that reporting and submission of MDR data is timely and consistent.
Complex Medical Device Reporting Systems Difficulties frequently arise in developing and following written MDR procedures. Frequently, personnel are inadequately trained on or informed about MDR principles.		Streamlined Medical Device Reporting Systems MasterControl forms keep MDR reporting consistent and according to regulatory requirements. The system also maintains a summary log of the types of events that have and haven’t been reported. MasterControl connects all MDR decision makers, making certain that information travels through the proper channels.
Deficient Systems No standardized review process for determining if an event is reportable and ensuring that MDR reports are submitted in a timely manner. Such shortcomings can lead to FDA citations.		Efficient Electronic Medical Device Reporting Syste: MasterControl facilitates rapid and thorough handling of customer complaints. With MasterControl, adverse events can be reported quickly and consistently.

Features and Benefits:

• Robust Reporting Capabilities: MasterControl eMDR features customizable standard reports. The types of useful reports provided by the system include:
  
  
  • Medical Device Reporting Summary: Presents the most relevant data for all MDRs.
    
  • Medical Device Reporting by Product: Groups MDRs by brand name.
    
  • Medical Device Reporting by Outcome: Complete with charts and number count for each type of outcome.
    
  • Medical Device Reporting Awaiting Acknowledgments: Presents the most relevant data for all MDRs awaiting one or more acknowledgments.
    
  • Medical Device Reporting Time to Report: Presents the time elapsed between the date of event and date of report with an average time for all MDRs.
    
  • Medical Device Reporting One-Year Trend: Includes a trending chart showing the number of MDRs over the preceding 12-month period.
    
• Automatic Launch: When a complaint form is filled out, an eMDR can be electronically initiated with appropriate fields automatically populated based upon certain triggers in the complaint form. In cases where follow-up is required, authorized users can launch a new MDR form from the parent form. MDRs can also be manually generated.
  
• Connected, Highly Visible System: MasterControl provides a structured MDR workflow. All designated users can review MedWatch form sections and MedWatch instruction pages are easily accessible.
  
• Optional Creation of an XML file for electronic submission to FDA: MasterControl allows users to generate XML packets in the format specified by the FDA.
  
• Effective Data Collection: MasterControl users can record the electronic submission date and add e-mail confirmations from the FDA Electronic Submission Gateway (ESG) directly into the system.
  
• Integration with Document Control and Other MasterControl Solutions: MasterControl eMDR seamlessly integrates with the document control system and other MasterControl applications that are useful in conjunction with the eMDR solution, including MasterControl Process™, MasterControl Documents™, and MasterControl PDF Publishing™.
  
• Field Mapping from MasterControl Customer Complaints MD™: Information entered into MasterControl Customer Complaints MD (such as descriptions of events or problems) can automatically populate appropriate eMDR form fields.