Market Complaints Record, Management and Tracking Software

Market Complaints Management Software automates the handling of complaints from initial complaint, acknowledgement, regulatory reporting, investigation through root cause analysis, assessments and closure with any associated CAPA.

Pharmaceutical manufacturing, Biotech and Life Science companies steer ahead in intense competitive world if their Compliant Management System is automated.

The Market Complaints Management Software solution allows complaint to be reported from anywhere through its web-based interaction besides allowing intake of traditional methods such as phone and e-mail.

Reported complaints are immediately triggered into investigations and assessments along with pre-defined reporting recommendations that guide the reporting to the regulatory authorities. Pre-defined responsibilities, fast paced investigations, elaborative assessments and effective CAPAs drive the organization in a streamlined process with robust handling and better closure timelines.

Features of AmpleLogic Complaint Management System:

Simplified Reporting

By making it easy for the complainant to define the complaint comprehensively with pre-define fields, the complaint is reported in-time allowing the organization to respond quickly and prevent adverse events. Besides, the diversified capture from sources web, phone and e-mail makes it easy and early complaint identification.

Robust Root Cause Analysis

The Root Cause Analysis allows tasks assignment to the investigators and across the departments based upon criticality of the complaint. These investigators in turn can create tasks and send it to participants for response. The responses are evaluated for identification of root cause and submitted for CAPA proposal. Due dates set ensure targeted closure of tasks and auto escalation upon overdue maintains the nature of the Root Cause Analysis to be robust and effective.

Regulatory Reporting

This feature provides the list of reporting actions applicable to the typical market complaints which forms recommendation criteria for what to be reported and which regulatory agency shall be reported. This automates the decision making which improves the response time with auto generated reports that can be sent to concerned authorities directly through the system.

Complaint Severity

Classifying a complaint determines the adversity of the complaint and how quickly an organization needs to resolute the complaint. This also automates the appropriate reviews across workflow steps and notifies as pre-defined.

Complaint Repetition

By evaluating a complaint for its repetition in recent past makes it is easy to review previous actions and improve the investigations. All complaints can be responded with effective corrective and preventive actions with continuous improvements.

Quality Systems Switch

With cross-functional workflows that move through quality systems and loop back is an essential need to make the interface as user-friendly as possible. The Market Complaints Management Software allows a swift switching between quality system with the harmonized single user-interface across all quality systems.

Integrated Quality Systems

The Market Complaints Management system is designed to be flexible in integrating with other quality systems and establish a seamless and controlled flow between change control and rest of the quality systems specially CAPA Management. The CAPA activities related to change control can be initiated, evaluated and implemented at Change Control System.

Automated Alerts & Notifications

Users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue and helps resolve the issue.

Benefits:

  • Global web accessibility of Market Complaints Management System 24 x 7 to intake the complaint and respond immediately.
  • Total compliance with 21 CFR part 11.
  • Comprehensive in defining complaint through logical data capture that enables clear understandings across investigations or assessments.
  • Repetitive evaluation to track current complaint to past complaint and respond with improved corrections.
  • Auto escalations in the event of change of complaint into adverse events.
  • Centralized repository to track complaints across multiple sites.
  • Live tracking and traceability of changes with status, automated alerts and notifications.
  • Metrics reports or trends that are exclusively analytical and visually eye catching.