Customer Complaints Management Software

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.

MasterControl Customer Complaints

Complete Customer Complaints Management

• Integrates with Other Applications
• Easy to Search
• Easy to Find
• Automation of Forms-Based Processes

MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.

Automating Document Control Processes to Comply With FDA and ISO Requirements

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.

21 CFR Part 820 – ISO 13485 Harmonization

MasterControl's Explorer is 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 Explorers and documents can be stored in multiple Explorers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

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.

Connected Customer Complaints Management

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.

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.

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.