Complaint Management

Whitepaper:  The Challenges of Complaint Handling, Investigations and Adverse Event Reporting

Customer retention, compliance with industry regulations and avoidance of potential product liability lawsuits are important objectives for all companies. An effective complaint management system is critical to achieving these goals. Companies that have a closed loop system to track the intake of complaints through investigations, CAPAs, and effectiveness checks will minimize the risk of product issues and regulatory scrutiny. 

Why a Complaint Handling Solution? 

Complaint handling solutions monitor developing trends through integrated tracking and reporting. Leading manufacturers are taking a global approach to their complaint handling process by implementing web-based systems that ensure compliance, reduces product safety risk and streamlines the complaint handling process.

Sparta Systems provides options for customers to fulfill requirements for a complaints process.  Complaints can be built directly into TrackWise as part of the holistic enterprise quality management software (EQMS) solution.  Additionally, Sparta offers a Salesforce-based complaints process that can integrate with Salesforce CRM data and move high-risk complaints to TrackWise to begin an Investigation or CAPA.

Using either choice for complaint management, your organization can centralize its complaint intake processes, efficiently manage site-level investigations and electronically process corrective and preventive actions. The Food and Drug Administration (FDA) and other government bodies are increasing enforcement and require better record keeping and complaint handling than ever before. TrackWise and Salesforce complaint management solutions can help reduce risk and is fully configurable across many industries including pharmaceutical/biotech, medical device and discrete manufacturing.

Benefits of a Complaint Handling Solution:

  • Streamline complaint management operations and reduce costs by improving response and closure times.
  • Implement a global approach to complaint handling with multi-site usage, multilingual capabilities, regional reporting requirements and unlimited security levels.
  • Protect brand reputation and increase customer satisfaction by ensuring that complaints are investigated and responded to in a timely manner.
  • Automate the process of assigning complaints and related investigations based on manufacturing location and product type.
  • Further develop management of the complaint lifecycle with real-time trending and escalation of potential safety issues.


Complaint Management FAQs

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