Complaint handling is one of the most critical aspects in the Life Sciences and Healthcare Industry. One of the primary objectives of any quality management and compliance program is to retain existing customers, improve product quality, and comply with industry regulations. In order to achieve these goals, it is imperative to have an effective and efficient complaint management system that has inbuilt capabilities to intake, investigate and respond to complaints. The system should also have robust alerting and reporting capabilities that allows monitoring of complaint metrics.


A Complete Cloud-Based Complaint Management System

agResponder serves as a Complaint Management System that is designed to manage all product complaints, with an integrated mechanism to implement effective and timely resolutions to customer issues. As a complete complaint management system, agResponder provides efficient triage and review of the complaint cases followed by robust investigation and root cause analysis mechanisms. agResponder allows seamless Integration with PV systems to publish adverse event cases and also provides actionable reports and analysis to stake holders for better decision making, eventually translating to safer products and increased customer satisfaction.


Complaint Intake from the Moment of Awareness

Complaints are captured directly into agResponder Compliant Module via intuitive forms, which prompt call center representatives to enter required product, customer and event information. The system determines the type of product (device/drug) and displays the appropriate fields intuitively for the call centre representative to capture necessary details.


Comprehensive Investigation and Root Cause Analysis

agResponder has inbuilt capabilities to perform investigative analysis for the received complaint. Investigative actions can be assigned to investigators who access their tasks from the listing screen. Investigation alerts and notifications are sent at real-time to the assigned users that facilitate immediate action to be taken on the case, thereby making the process faster and efficient. The investigators can determine the root cause for each investigation performed, aiding quality and compliance departments to take necessary actions based on the detailed analysis available in the system.


Workflow Automation with Rule-Builder

 The highly intuitive workflow routes the Complaints automatically and distributes the Complaints workload across the available staff based on product, priority, user role, privileges and agent availability. The workflows are entirely configurable, allowing for variances in regional complaint management.

Response Templates and Documents and Literature are capable of full version tracking to expedite the approval cycle and also ensure only approved and valid content is used for investigation and for responding to a complaint.

The new integrated rule builder helps streamline and automate the complaint management process with easy-to-define rules that can trigger escalations, warnings or alert,s while the task module also provides alerts and reminders of key activities.


Management Reporting and Complaint Analysis

agResponder’s powerful reporting functionality provides a simple yet powerful reporting tool to generate a wide variety of reports. Standard and custom reports and charts provide essential data for management reporting, trending and analysis, to help track the communication and improve response timelines. A personalized dashboard with a unified view of critical metrics helps identify significant gaps in complaint handling and take necessary action to enhance the communication process. Reports can be generated in a variety of formats – including PDF, Microsoft Word, Excel or PowerPoint that can be viewed by the management to make meaningful and effective decisions.


Privacy and Security

agResponder is 21 CFR Part 11 compliant solution that supports privacy requirements, including configurable data access to specified roles, application time-out and user lock on multiple failed login attempts. The inbuilt audit trail feature keeps track of all the actions that were taken on the case.


Key Benefits:


  • Facilitates compliance and adherence to regulations
  • Delivers robust Investigation and Root Cause Analysis capabilities
  • Provides flexible Workflows and integrated Rule-builder
  • Provides comprehensive management reports, trending and performance metrics
  • Allows Complaint Case creation via Email and Fax
  • Allows integration with Medical Information System (agInquirer) and Safety Systems (ARISg and other PV systems+
  • Allows integration with agReporter (Web based portal and Mobile applications on iOS and Android) for Complaint creation and submission.
  • Facilitates transparency and communication across departments via inbuilt Correspondence and Task module
  • Provides greater visibility of supplier problems
  • Delivers improved efficiency and timeliness of responses resulting in higher overall customer satisfaction

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