Qualityze Achieves ISO 9001:2015

Tampa, FL – January 30, 2020 – Qualityze, Inc. has been certified as ISO 9001:2015 – compliant after an in-depth audit of the company’s internal operations.

Complaint Management : Transforms Customer Complaints into Growth and Improvement Opportunities

Whether you are selling a product or providing the services, you are likely to receive customer complaints. Failing to manage customer complaints could hamper your brand reputation, customer relationships, and compliance. You must establish a complaint process to resolve quality issues and ensure excellent customer service. Addressing customer issues on time increases customer confidence.

Since customer satisfaction is of paramount importance, you must have a robust complaint handling system integrated into the quality management system. Qualityze Complaint Management provides a closed-loop mechanism to implement effective, timely resolutions to customer issues and adverse event management. It complements your established complaint handling process by enabling you to manage and enforce a full complaint lifecycle effectively.

With Qualityze Complaint Management Software, you can standardize the processes to:

  • Document Customer Issues
  • Identify the Type of Compliant
  • Perform Risk Assessment
  • Review Device History Records
  • Conduct Product Evaluation
  • Perform Investigation with RCA
  • Manage Customer Responses
  • Implement Action Plans
  • Global Regulatory Reporting and Submissions

Complaints Management Software Overview

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 customer Complaints management and regulatory reporting are an inevitable part of the regulated industry.

Qualityze Complaints Management software (QCM) solution complements your established Complaints handling process by enabling you to manage and implement the full Complaints lifecycle effectively. It helps you with;

  • Documentation
  • PHR Review and Product Evaluation
  • Root Cause Investigation
  • Global Regulatory Reporting and Submissions
  • Managing Customer Responses
  • Triggering Internal Or External CAPAs

Qualityze Complaints Management Software System comes with robust analytics and reporting capability that helps Complaints managers to perform trend analyses and spot recurring problems quickly and easily. The interactive executive dashboards provide meaningful Complaints statistics to c-level management to make informed decisions to drive continuous improvement and regulatory compliance.

complaints management system
customer complaint handling software

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

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

Besides this information, you have an option to create additional custom fields to capture data 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.

customer complaint management system

PHR Review and Product Evaluation

Once you have documented all the complaint details, you can review the Device or Product History records for Nonconformance, CAPAs, Inspections, etc. along with the relevant information and outcomes for the potential root cause. It can provide complaint handlers valuable insight to perform a thorough evaluation and investigation.

Additionally, you can perform Product Evaluation with an inhouse sample or returned device from the customer to better understand the complaints and summarize in the evaluation report.

Reviewing and evaluating history records will help you decide whether the investigation is required.

Root Cause Investigation

customer complaint management solution

The root cause investigation of Complaints plays a significant role in the functioning of the Complaints system. The extent of the investigation depends on several criteria such as criticality, risks to the patient or end-user, risks to the company, the scope 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 record 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 Complaints.

Triggering Internal or External Corrective and Preventive Action (CAPA)

Qualityze Complaints Management System is a robust solution that ensures the action plans are developed based on accurate, appropriate, and timely investigation reports.

Based on the root causes identified, you can develop and implement the action plans such as Risk-Based, Correction, Corrective, and Preventive to resolve the customer complaint effectively.

Right action plans can help improve product quality, making it safer and better for the intended use.

complaints management software solution

Global Regulatory Reporting and Submission

QMS Software for Complaints Management

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 a reportable event and a timeline is based on the outcome of a decision tree.

With Qualityze issue tracking and customer Complaints management software, you can create your decision tree based on the region for the Complaints 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.

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. A timely response to the customer is very critical to show an organization’s commitment to resolving the issue.

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

Before closure, you can perform a final review with the Closure summary and provide the appropriate responses to the customer.

Complaint Management and Tracking Software

Why Complaints Management Is Important?

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

  • Demonstrate A Regulated Complaint 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

How does Qualityze Complaint Management Help Businesses?

Streamline complaints management process for efficient and effective customer responses with Qualityze configurable workflows. With Qualityze Complaint Management, you can;
  • Capture Customer Complaints
  • Streamline Complaint Investigation and RCA
  • Manage Customer Responses
  • Triggering Internal or External Corrective and Preventive Action (CAPA)
  • Simplified Global Regulatory Reporting and Submissions
  • Get Greater Process Visibility to Develop Action Plan(s)
  • Integrate with Existing Business Systems
  • Controlled Complaint Records and Data

Capture Customer Complaints

Qualityze Complaint Management allows you to manage the complaint process cycle by creating standardized workflows. You can capture all the essential details, including Title, Description, Occurrence Date, Aware Date, Location, Product Information, Reported Date, Reported By, Complaint Owner, and more.

You can also utilize the Customer Experience Type templates to specify workflows for the formal processing of inquiries, product complaints, and other adverse events reported by your customers.

With Qualityze, you can address customer issues while reporting adverse events on time.

complaints management process

Streamline Complaint Investigation and RCA

Qualityze Complaint Management allows you to review the Device or Product History records for Non-conformance, CAPAs, Inspections, etc. along with the relevant details and outcomes for the potential root cause. It can provide complaint handlers valuable insights to perform a thorough evaluation and investigation.

You can also perform product evaluation with an in-house sample or returned device from the customer to better understand the complaints and summarize it in the evaluation report.

Investigation done right ensures the most effective resolution for the customer complaints and you can make most of your standardized complaints process. Qualityze documents all the investigation records as objective evidence for the resolution activity.

Improve Customer Experiences

Qualityze Complaint Management helps perform a final review with a closure summary to provide the appropriate responses to the customer. It increases customer confidence. Having a standardized complaints management process help making customer experience delightful, providing you fantastic opportunities to grow.

With Qualityze, you can quickly track the complaints and their resolution progress to ensure that your customer experience doesn’t suffer due to delayed escalation. Always remember “A Satisfied Customer is the Best Business Strategy of All”

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Align Complaint Investigation with CAPA Process

complaints process management

Qualityze Complaint Management allows you to perform investigation utilizing one or more investigation tools to identify potential root causes. Based on the root causes identified, you can develop and implement the action plans such as Risk-Based, Correction, Corrective, and Preventive.

Aligning complaints process with CAPA ensures that every quality issue is investigated and analyzed well to identify effective resolution. With Qualityze, this alignment process becomes even more simplified due to the user-friendly interface.

Simplified Global Regulatory Reporting and Submissions

Qualityze Complaint Management comes with a user-friendly interface. It allows you to quickly and promptly generate the submission report, using pre-defined templates for reporting complaints to the regulatory agency.

With Qualityze Complaints Management, you can meet all your business regulatory reporting requirements for the global marketplace through pre-defined templates. The templates are fully configurable to give your more flexibility to generate and submit reports to regulatory committees.

Hence, experience more flexibility to manage global regulatory reporting and submissions with Qualityze.

Complaints system

Get Greater Process Visibility to Develop Action Plan(s)

Complaints software

Qualityze Complaint Management has powerful reporting and search capabilities to provide greater visibility into complaints data, enabling your teams to make smarter and effective decisions. With Qualityze, you can get valuable insights into recurring complaints, previously reported complaints about a product, action plan(s) implemented, and much more.

The increased visibility of the complaints processes also increases management oversights and help them make critical decisions. It helps them understand the risks associated with the issues reported. Accordingly, they can align the complaints workflows and resolve the most critical complaints first.

Integrate with Existing Business Systems

Qualityze Complaint Management seamlessly integrates with all the existing business systems and third-party applications to collect data from different sources. It helps you identify effective resolutions and action plan(s).

Our solution enables you to demonstrate the commitment to increased performance, customer satisfaction, continuous improvement, and compliance.

With Qualityze, you can significantly reduce the complaints process and invest your time in core business activities.

Complaints handling process

Controlled Complaint Records and Data

customer complaints management

Qualityze Complaint Management allows you to keep all the complaint records and the relevant action plans recorded securely stored on a centralized cloud platform. Following your complaint processes documented helps maintain compliance with regulatory standards, including FDA 21 CFR Part 11 and EU Annex 11(e.g., digital records and electronic signatures).

Qualityze automatically records all the complaints and their respective resolution activity to help your team perform analysis of complaints trends quickly, allowing them to be more productive.

Qualityze Complaint Management – Ensuring Timely Customer Response Management

Qualityze Complaint Management works for every industry, including – Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Cannabis/Hemp/CBD, Nutraceuticals, Biologics/Biotech, Food and Beverages, Automotive, Aerospace, Defense and Logistics to manage customer responses, while showing compliance with applicable regulatory standards.

Qualityze Complaint Management Solution comes with;

  • Centralized Complaints Database
  • Configurable Workflows
  • Reporting and Dashboards
  • Automated Email Approval
  • Alerts and Notifications
  • E-Signature
  • Seamless Integration to external systems
  • Chatter, and more.

Qualityze EQMS – The Enterprise Quality & Compliance Management Platform to Manage Customer Complaints and Regulatory Reporting

Effective management of customer complaints and regulatory reporting is an inevitable part of every regulated industry. Qualityze Complaints Management helps standardize the complaints management process to make customer experience delightful. It gives you complete customer insights while helping you make significant business improvements for improved profitability, reduced costs, and enhanced customer satisfaction. With our powerful and effective complaints management solution, you can efficiently manage customer responses to ensure product quality, safety, and global compliance.

Qualityze EQMS Suite helps enterprises align their quality processes with their business objectives while mitigating operational challenges. Built on the most powerful and secure cloud platform, Salesforce.com, Qualityze provides unparalleled benefits to managing customer complaints. We empower you to optimize your quality processes by giving you control and confidence in managing your customer complaints and responses, allowing you to focus on business growth opportunities.

Qualityze prepares you to succeed with a next-generation approach to manage customer complaints in a compliant and timely manner to attain highest customer satisfaction.

Experience Qualityze Difference to Optimize Quality

Qualityze EQMS Suite enables you to maintain high quality standards while experiencing difference with:

Configurable Cloud-Based Platform

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

Adherence to Compliance Standards

Qualityze Customer Complaints 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.

User-Friendly Interface

Qualityze Complaints Management Solution comes with an intuitive interface to ease the process of Complaints 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.

Making Customers Experience Delightful with Improved Complaints Management System

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

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

If you don’t have a well-structured way to handle your customer Complaints, you may not be able to retain your customers for long. It would be best if you get the Qualityze Customer Complaints Management and Handling Software to keep track of the customer Complaints and resolve them at earliest. If you want to explore the product functionality in and out, 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.