Industry Solutions

Customer Complaint Management & Medical Device Reporting

Medical Device manufacturers must record, track, and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Parts 820. In addition to indicating a failure in an organization's quality system, a customer complaint may also indicate that there are potential product safety issues.

Leading medical device manufacturers are taking a global approach to customer complaint handling. In addition to investigating complaints, companies must also analyze them for reportability to health authorities in the case of adverse events. As a result, companies require scalable and flexible management systems that enable them to implement enterprise complaint handling and medical device reporting processes.

TrackWise Customer Complaint Management Solutions

TrackWise software enables medical device manufacturers to effectively implement a global and consolidated approach to managing customer complaints and medical device reporting. TrackWise ensures compliance, reduces product safety risk, and streamlines workflow processes. The system integrates complaint handling and medical device reporting into the overall quality management system, allowing users to benefit from a single interface and eliminating the need for complex and costly custom integration.

TrackWise enables your company to centralize complaint intake from call centers, distributors, sales, and quality management functions. Integration with ERP systems such as SAP, JDE, Oracle, and others, provides direct look-up of and linking to master product information to improve accuracy and streamline operations.

TrackWise's powerful workflow engine assigns and monitors investigations and root cause analysis steps, while its 24/7 business rules engine escalates any complaints or adverse event reports that are significant in nature or that are falling behind schedule. TrackWise also provides tracking of product returns, generates response letters, and supports printing and reading of bar code labels.

Medical Device Reporting

TrackWise provides configurable decision trees for regulatory assessments for any health authority including FDA, EU, Canada, Japan, Australia and others. All reportability assessments and resulting reports including Baseline reports, MedWatch (3500A), EU Vigilance, and others may be produced directly from the TrackWise system.

Integrated CAPA Management

TrackWise also enables your organization to conduct detailed trending and manage all related CAPAs as part of its global complaint management system, enabling your company to perform consolidated trending for internal quality management functions.

Benefits

  • Implement a global approach to compliant handling with multi-site usage, multilingual capabilities, regional reporting requirements, and unlimited security levels.
  • Ensure scalability to handle a high volume of complaints as well as complex processes related to serialize and non-serialize devices.
  • Consolidate and improve regulatory assessments and medical device reporting with integrated decision trees and direct regulatory report generation.
  • Increase compliance, eliminate lost records, and ensure on-time reporting of adverse events.
  • Automate the process of assigning complaints and related investigations based on manufacturing location and product type.
  • Reduce administrative costs with integrated letter generation, product return tracking, and improved workflow management.
  • Improve management of the complaint lifecycle with real-time trending and escalation of potential safety issues.
  • Streamline operations and reduce costs by improving response and closure times.
  • Identify systematic quality issues with ad hoc search tools, enterprise reporting and trending, and AutoTrending, which automatically detects developing trends and escalates them to management.
  • Integrate and relate complaint handling and adverse event procedures and reporting in line with FDA thinking and industry best practices.
  • Enhance root cause analysis by more effectively managing the investigation process and leveraging root cause drill-down tools.
  • Provide a validated environment compliant with FDA, EMEA, and other regulatory authority requirements.