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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, take action, 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 by,

  • Documenting
  • Root Cause Investigation
  • Customer responses
  • Trigger internal or external corrective and preventive action (CAPA)
  • Global Regulatory Reporting and Submissions

Qualityze complaints management software system has powerful analytics and reporting capability 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.


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 and assess for regulatory reporting.

With Qualityze’s 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 Investigating

The root cause investigation of a complaint is an important part 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 information that will help to understand the cause. Product Investigation is performed internally to check for any existing nonconformance during the manufacturing process that may have contributed to the complaint.

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.

In Qualityze’s you can create your decision tree based on the country. For a reportable event/incidents, 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) e.t.c., you can quickly and promptly generate the submission report.

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