Customer Complaints Management


MasterControl Customer Complaints Management suite automates and manages the customer complaints management process in an efficient and cost effective manner

Customer complaint management is essential to the success of any regulated business. It is especially critical for regulated companies because complaints may indicate serious safety issues. For example, under the Current Good Manufacturing Practice (CGMP) regulations outlined in 21 CFR Parts 210-211, pharmaceutical companies are required to establish written procedures for complaint handling regarding a drug product and to determine whether a complaint represents a serious adverse experience that needs to be reported to the FDA.

The MasterControl integrated quality management suite is a configurable and easy-to-use software solution that helps ensure regulatory compliance with customer complaints management. Recognizing that validating a software solution (as required by 21 CFR Part 11 ) is a necessary component in CGMP compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

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Compliant Customer Complaints Management

Sustained Customer Complaints Management and Compliance: MasterControl helps manufacturers attain and sustain compliance with ISO quality standards by optimizing the complaint-handling process, speeding up the turnaround from complaint submission to resolution, and keeping the overall quality system always ready for ISO quality audits.

  • Increased Efficiency Through Automation: MasterControl complaint software automates all tasks pertaining to customer complaints, including notification, follow-up, and escalation of overdue assignments for effective customer complaints management. Automation helps simplify the compliance environment, making it easier to stay compliant.
  • 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, automatically moving to the internal investigation step, and culminating with a resolution of the issue.
  • Centralized Repository: For effective customer complaints management all documents related to customer complaints will be stored in a secure, centralized repository, making it easy to search and retrieve them during an FDA inspection or an ISO audit.
  • Analytics and Reporting: MasterControl's advanced analytics and reporting capability increases customer complaints management oversight and demonstrates 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: A customer complaint may turn out to be the reporting of an adverse event, which comes with its own set of regulatory requirements. This customer complaints management solution 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.
  • Customer Complaints Management - Audit Trail: Provides a secure, time-stamped audit trail as required by 21 CFR Part 11. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
  • Revision Control: MasterControl ensures that only the current version of a document is available.

Connected Customer Complaints Management

Integrated Quality Management: MasterControl connects the paperless customer complaints management process with other quality processes for a holistic approach to quality management.

  • Easy Access: MasterControl Customer Complaints management suite is web-based so it can connect employees, customers, suppliers, and others involved in the customer complaints management process regardless of location.
  • External Links: MasterControl connects the complaint-handling process to the rest of the quality system, providing links to corrective actions and adverse-event handling. Via an external link, this customer complaints management solution can be integrated 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. This connectivity will help managers track a complaint from initiation to completion and give them the ability to proactively improve the complaint-handling process.
  • CAPA Integration: MasterControl provides the option to integrate customer complaint handling with the corrective and preventive action process to automatically escalate any serious quality problem.

Complete Customer Complaints Management

Enterprise-wide Product Application: MasterControl can handle every department's forms and documents-based processes, making it an ideal enterprise-wide customer complaints management solution.

  • Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
  • Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.
  • Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly with respect to customer complaints management. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.
  • Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new customer complaints management forms.

Learn More About Customer Complaints Management

For more information about complaint handling or customer complaints management, please feel free to contact a MasterControl representative.