Customer Complaint Management & Adverse Event Reporting

Blood and Tissue centers and manufacturers must record, track, and trend customer complaints according to Good Manufacturing Practices (GMPs), FDA regulations, and industry standards. In addition to indicating a failure in an organization's quality system, a customer complaint may also indicate that there are potential safety issues.

TrackWise Customer Complaint Management Solutions

TrackWise software enables the blood and tissue industry to effectively implement a global and consolidated approach to managing customer complaints and adverse event reporting. TrackWise ensures compliance, reduces product safety risk, and streamlines workflow processes, enabling your company to achieve optimal class results.

TrackWise enables your organization to centralize complaint intake from call centers, blood collection centers, and quality management functions. TrackWise 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 events that are significant in nature or that are falling behind schedule. TrackWise also provides tracking of response letters and supports printing and reading of bar code labels.

Adverse Event Reporting

TrackWise supports MedDRA dictionaries for adverse event coding and 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 MedWatch (3500A), BPDR, EU Vigilance, Canadian Adverse Drug Reaction, and others may be produced directly from the TrackWise system.

Integrated CAPA Management

TrackWise also enables your organization to 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

• Increase compliance, eliminate lost records, and ensure on-time reporting of adverse events.
• Consolidate and improve regulatory assessments and adverse event reporting with integrated decision trees and direct regulatory report generation.
• Automate the process of assigning complaints and related investigations.
• Reduce administrative costs with integrated letter generation, product return tracking, and improving 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.