Customer Complaint Handling Software - Features & Benefits

Automating Paper-Based Customer Complaint Processes in FDA and ISO Environments

Customer complaints are inevitable in any kind of business. They are especially critical in the life sciences and general manufacturing industries, where complaints may indicate serious safety issues. In both FDA and ISO environments, customer-complaint handling is considered an essential part of the quality system — and an important factor in ensuring compliance.

How Can MasterControl Customer Complaints™ Benefit You?

MasterControl Customer Complaints™ is a complete and easy-to-use solution that will help you automate complaint handling, integrate it with the quality system, and manage complaint resolution more effectively. Here's how it can answer key challenges in the customer complaint process:

Customer Complaints Handling Challenges		MasterControl Customer Complaints™ Software Solution
Different Sources In a manual system, customer complaints may come from different sources (e-mail, phone, fax, letters, corporate Web site, sales reps, etc.). These complaints may languish in someone's "in" box, especially if there is no formal and standard procedure for processing them. Without a cohesive structure that captures complete information in a timely manner, it is almost impossible to formulate a strategy for complaint resolution.		Centralized Source MasterControl Customer Complaints software provides a secure and centralized platform for receiving customer complaints and storing all subsequent documentation pertaining to investigation and correction of the problem. A single, cohesive system makes search and retrieval of complaints and related data easy. The solution offers the capability to formalize and standardize complaint handling through a simple three-step process. MasterControl is Web-based, so customers can log complaints from virtually anywhere.
Disconnected Processes When a company uses different tools that are not connected, tracking complaints and follow-up work can be a major obstacle. If there is no standardized response to complaints, the required documentation may fall through the cracks and correction of the problem may be delayed.		Connected Software System MasterControl connects the customer-complaint process to the rest of the quality system, providing links to corrective actions and adverse-event handling. Via an external link, customers can integrate MasterControl Customer Complaints with other computer systems. For example, a link can be provided on a company Web site within a CRM application (or any application that supports URL links), so employees, customers, or partners can easily initiate a customer complaint. Connectivity will help managers track a complaint from initiation to completion and give them the ability to proactively improve the complaint process.
Inefficient Complaint Process A manual system is plagued by bottlenecks: misplaced or overlooked complaints coming from disparate sources, incomplete information, lack of follow up, and inadequate response. All of these can result in delayed complaint resolution.		Efficient Complaint Process MasterControl reduces the life cycle of the complaint process by streamlining different steps and consolidating multiple sources of complaints under a single platform. It provides a customizable form that captures all necessary information, provides automatic follow-up via e-mail notification, and incorporates escalation to ensure timely response.

Features

MasterControl Customer Complaints is a robust software solution that manages complaint handling more efficiently and effectively with the help of the following features:

Simple Three-Step Process: – This best-practice process is incorporated in a pre-configured, multi-page form that starts with the processing of a customer complaint by the coordinator/manager, automatically moving to the internal investigation step (conducted either by an expert or a team of experts), and culminating with a resolution of the issue as approved by the appropriate manager. Additional forms can be customized according to a company's special needs.

Compliant System: – 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. MasterControl maintains a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record (such as a customer complaint file), when the action occurred, and the changes made to the record. MasterControl meets FDA requirements for electronic signature and software validation. It facilitates compliance with regulatory standards such as ISO 9000, ISO 14000, and ISO 13485.

Analytics and Reporting Tool: – MasterControl's advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies. The solution includes the following customizable reports:

• Complaint summary
• In-process complaints
• Complaints categorized by type, product, and department
• Trending categorized by complaint type, product, and department
  
  

MedWatch Form: – For an FDA-regulated company, a customer complaint may turn out to be the reporting of an adverse event, which comes with its own set of regulatory requirements. MasterControl Customer Complaints includes the FDA's MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless handover to an adverse events specialist while ensuring that all required data is immediately collected.

CAPA Integration: – MasterControl gives you the option to integrate customer-complaint handling with the corrective and preventive action CAPA process to automatically escalate any serious quality problem.

Sustained Compliance: – Regulated companies cannot ignore customer complaints. They are the ultimate indicators of product/service quality. Every complaint has to be properly evaluated, investigated, and the situation corrected. MasterControl Customer Complaints is designed to streamline and simplify the complaint process, foster efficiency throughout the enterprise, and keep compliance costs down. MasterControl will not only help you attain FDA and ISO compliance — but sustain it year after year. With MasterControl, you can count on a partner that will support your compliance efforts over the long haul.