Automating Complaint Management for Life Sciences: A Best Practice Approach

Automating complaint management reduces potential risk to public safety and subsequent FDA action by expediting investigations and root cause analysis of safety and efficacy issues. Quality management software built on best practices eliminates disconnected processes and provides a centralized, controlled system to manage the complaint handling process until the investigation is satisfactorily closed and reported if necessary.

Learn the industry’s best practices for initiating and implementing an electronic complaint handling solution for pharmaceutical, medical device, and biotech organizations. See how automating a process—from complaint intake, through review, investigation, regulatory reporting, and returned product shipment tracking—can ensure complaints are handled quickly and efficiently, utilizing the right resources at the right time.

Key focus areas include:

  • The characteristics of an effective complaint management process
  • The workflow steps involved in processing a complaint
  • The identification of typical attributes to be collected and managed throughout a complaints resolution process
  • Customer communications techniques
  • Enforcement of electronic signature controls
  • Regulatory Reporting and electronic submissions to regulatory agencies
  • Key capabilities your complaints management system should include

Download the AssurX Complaint Management Solution Brochure

AssurX’s Complaint Management solution enables an automated approach to a customer’s product complaint process. Streamline the complaint lifecycle from intake through investigation, root cause analysis, corrective action, and regulatory reporting throughout the product lifecycle. Reinforce accountability and speed to action through task management and dashboards.