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Ever changing regulatory landscape, potential product liability issues and cost of compliance are making organizations to adjust the way they handle, manage, settle, and report customer complaints. Effective management of customer complaints and regulatory reporting are an inevitable part of the regulated industry.

Qualityze Complaint Management software (QCM) solution complements your established complaint handling process by enabling you to effectively manage and implement full complaint lifecycle including:

  • Documentation
  • Root Cause Investigation
  • Managing Customer Responses
  • Triggering Internal or External Corrective and Preventive Action (CAPA)
  • Global Regulatory Reporting and Submissions

Qualityze complaints management software system comes with a powerful analytics and reporting capability that helps complaint managers to perform trend analyses and spot recurring problems quickly and easily. The interactive executive dashboards provide meaningful complaint statistics to c-level management to make informed decisions to drive continuous improvement and regulatory compliance.

Documentation

Customer complaints and regulatory reporting are an inevitable part of the regulated industry. When it occurs, you should be able to document the problem quickly and clearly that can be assessed for regulatory reporting.

With Qualityze complaints management software system, this can be achieved by completing the Initiation steps. Within the Initiation step, you can capture key information such as:

  • Complaint Description and complaint Code
  • Occurrence Date
  • Aware Date
  • Patient Information
  • Hospital Information
  • Product Information
  • Reported Date
  • Reported By
  • Location
  • Complaint Owner and Others

Besides this information, you have an option to create additional custom fields to capture information that your business needs. Once the record is saved, a unique number will be assigned by the system for you to keep track of the customer complaints.

 Root Cause Investigation

The root cause investigation of a complaint plays a very important role in the functioning of the complaint system.  The extent of the investigation depends on the several criteria such as criticality, a risk to the patient or end user, the risk to the company, extent of the defect, etc.

In Qualityze, you use the combination of different tasks to document the investigation result or outcome. You can perform two types of investigation to identify the cause: Customer Investigation and Product Investigation. The flexibility of the system allows you to document multiple root causes. Additionally, you can also document the results of the investigation.

Customer Investigation is related to the information that you want to collect for understanding the root cause. Product Investigation is performed internally to check for any existing nonconformance during the manufacturing process that may have contributed to the complaint.

Managing Customer Response

Customer Response is an activity that an organization uses to respond to a customer who has filed a formal complaint about the products or services. Timely response to the customer is very critical to show an organization’s commitment to resolve the issue.

In Qualityze, you can generate a customer letter with using a predefined response template. You also have an option to update or change the template based on your organization’s requirement. Having a template provides a format, structure, and style that can be used to write a formal response to a customer complaint.

Regulatory Reporting and Submission

Some of the complaints need to be reported to the regulatory agency of the country where the incident occurred. There is always a specific timeframe that needs to be followed to complete the regulatory reporting and submission. The determination of reportable event and a timeline is based on the outcome of a decision tree.

With Qualityze complaints management software, you can create your decision tree based on the region for the complaint’s management. For a reportable event/incident, the system auto-generates a task with a timeframe auto-calculated by the system. Using the pre-configured forms provided by FDA (MedWatch FDA MDR 3500), European Medical Devices Directive (93/42/EEC) (MEDDEV 2.12-1), Health Canada (MDPR), Therapeutic Goods Administration (TGA) etc., you can quickly and promptly generate the submission report.

Industries Qualityze Offers Complaint Management Implementation for.

Qualityze Complaint Management System works for different industries with the same effectiveness and efficiency. From General Manufacturing to Life Sciences, Pharmaceuticals to Healthcare, Biotech to Metal Manufacturing, Heavy Machinery to Food and Dairy, Automotive to Aviation or Aerospace, Defense to Medical devices, Logistics to Nutraceuticals, our solution makes it easy and convenient for you to manage customer complaints in order to maintain quality relationships. Our software comes with:

  1. Configurable Cloud-Based Platform

Designed on a cloud-based platform powered by Salesforce, Qualityze Complaints Management System is best-in-class solution for the organizations to take care of their customers’ complaints in a timely manner. This configurable software enables any organization to strengthen their relationship with the customers by listening to them and resolving their issues.

  1. Adherence to Compliance Standards

Qualityze Complaint Management Software system is aligned with all the latest standards including the Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc. to enable organizations with superior quality customer response systems.

  1. User-Friendly Interface

Qualityze Complaints Management Solution comes with an intuitive interface to ease the process of complaint management for both customers as well as providers. Whether you are in automobiles industry or life sciences, handling customer feedback is quite imperative. All this is simplified in Qualityze to make your customers feel heard and valued.

Why Complaints Management is Important?

Complaints management to be conducted in a precise and effective manner depends on numerous factors like timely acknowledgment, workflow to resolution, and the final results that go in favor of both customer and provider. It encourages any organization to:

  • Have A Regulated Documentation Process
  • Perform Root Cause Investigation
  • Give Customers a Timely Response
  • Establish a Region-Wise Decision Tree
  • Handle Reportable Events and Generate the Submission Report

Making Customers Experience Delightful with Improved Complaint Management System

Qualityze Complaints Management System enables organizations to maintain transparency with their customers when it comes to listening to their feedback or complaints especially if they are highly regulated. Our solution makes the customer journey and experience even more delightful by instilling an organization with a well-defined complaint management process.

Our solution helps organizations to take care of every concern that help them achieve customer satisfaction – the motto they rely on. This configurable software comes with a scheduler to keep the complaint processing in a timely order because it could adversely affect the brand image.

Don’t you have a well-structured way to handle your customer complaints? You might not build a healthy relationship with your customers for long. You need Qualityze Complaint Management Software to keep a track of the customer complaints and resolve them at earliest. If you want to explore the product functionality in and out, simply request a product demonstration today. To know more about our products, get in touch with us on our contact page and we will get back to you at earliest.

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