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QuTrack QMS - Market Complaints

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Market Complaint Scenario

Every Life Sciences Company realizes the risks pertaining to its reputation if it fails to meet the Patient Safety. The best way to mitigate these risks is by understanding the Patients/ Customers through their complaints directly or indirectly and avoiding adverse events that put the Company and its reputation in an unimaginable situation. Traditionally the manual Market Complaint systems handle complaints that can in a way be improved in many terms from Complaint logging, Responsiveness to an Effective Timely Closure through automated Market Complaints Management Software with smart features.

Market Complaints Management Software Solution

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

The Market Complaints Software is designed to fully integrate with other critical Quality Systems such as CAPA to manage CAPA activities. The corrective or preventions actions which require changes are initiated, evaluated and implemented at CAPA Management with enabled tracking at the Market Complaints Management Software source Quality System.

With configurable workflows and flexible workflow components/ sections it is easy for the Market Complaints software to be transitioned into your current market complaints handling process within in a short period. Comprehensive Tracking and Trending of market complaints is made available at the click of a button with Summary Reports and Metrics Reports. Market Complaint Summary Report gives real-time summarized information within the selected market complaint and metrics reports bring high-level and in-depth performance visibility of market complaint closure at any given point.

Besides providing best approach for effective closure of market complaint, the Market Complaint Management software is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.

VeServ Market Complaints Management Advantage

Market Complaints Management software was developed based on extensive research on guidelines from various regulatory agencies and be practical and problem oriented with these value-added core benefits:

  • Global web accessibility of Market Complaints Management System 24 × 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
  • Guided recommendations and criteria for reporting to regulatory authorities
  • 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
  • Fast paced investigations with robust root cause analysis tools
  • Live tracking and traceability of changes with status, automated alerts and notifications
  • Capabilities to integrate and establish closed-looping with other Quality Systems
  • Customizable workflows to suit your current process
  • Metrics Reports or Trends that are exclusively analytical and visually eye catching

Apart from being an industry standard and an effective Market Complaints Management Software, the system has several key features that enable organization and users to continuously improve the way complaints are reported, responded and closed.

Key Features

Simplified Reporting

By making it easy for the complaint to define the complaint comprehensively with easy to 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 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 a 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 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.

Auto Spell

Entered information needs to be described in detail and spelled correctly. The in-built spell check feature ensures all text related information entered into the system is spelled correctly. By auto suggesting and auto correcting with good user interface, users can quickly complete data entry which helps in avoiding repetitions and reduces time spent.

Automated Alerts & Notifications

This feature ensures that 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.

Audit Trails & E-signatures

The trail of the record is tracked and time-stamped providing details of actions performed, at the workflow steps giving in-depth traceability about who performed the action and at what time. Also the system features capturing of the user-consent to the action performed be entering a highly secured and high-level password i.e. e-signature.

Real-time Reports

Market Complaint Summary Reports that provide real-time summary without opening the record helps personnel holding critical positions to save time by viewing the entire information in one go. Generation of reports on the status of the records enables high visibility of the Complaints Management System and Market Complaints. With eye catching graphical representation the reports are informative and impressive.

You can feel free to reach us to know more about VeServ Market Complaints System and get your questions answered.

Industries that can benefit from our Solution

  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages