Complaint Handling & Regulatory Reporting

Medical device manufacturers must record, track and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. In addition, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident. As a result, companies must implement best-of-breed complaint handling systems that enable them to implement enterprise complaint management coupled with medical device complaint reporting processes.
 
Sparta Systems' complaint management software and regulatory reporting compliance software enables organizations to implement an effective, consolidated, global approach to managing customer complaints and regulatory reporting, including electronic reporting methods such as eMDR and eMDV.
 
Sparta Systems' regulatory reporting and complaint management software facilitates compliance, reduces product safety risk and streamlines workflow processes. Sparta’s software solution integrates complaint handling and medical device reporting into the overall quality management system, giving users the benefit of a single, familiar interface and eliminates the need for complex and costly custom complaints software integration.

Turning Medical Device Complaints into Quality Insights

Definitive Guide to Complaint Handling

Benefits of Complaint Management & Regulatory Reporting Software:

  • Improves management of the complaint handling lifecycle with real-time trending and escalation of customer complaints  
  • Automates the process of assigning complaints and related investigations based on manufacturing location, product type or other established customer complaint criteria
  • Provides Error-proof processes by utilizing decision trees, specific to a company’s products, to help drive complaint management investigations and determine regulatory requirements around the world  
  • Provides a validated environment compliant with FDA, European Medicines Agency and other regulatory authority requirements  
  • Automates the eMDR and eMDV process by leveraging industry-standard EDI technology and reduce effort to comply with government mandates 
  • Integrates with existing Customer Relationship Management (CRM) systems, globally, to ensure automatic generation of complaints and feedback of investigation status to regional complaints software systems 
  • Consolidates and improve regulatory assessments and medical device reporting with integrated decision trees and the ability to generate and submit MedWatch forms electronically using electronic medical device report (eMDR) functionality 
  • Reduces administrative costs with integrated letter generation, product return tracking and improved complaints software workflow management 

Click here to learn more about Sparta Systems Complaint Handling Solution TrackWise

Click here to learn more about Sparta Systems Complaint Handling Cloud Solution 123Compliance 

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