Compliant Customer Complaint Process
Sustained Compliance: MasterControl helps FDA-regulated and ISO compliant companies attain and sustain FDA GMP compliance by optimizing the customer complaint process, speeding up the turnaround from complaint submission to resolution, and keeping the overall quality system always ready for FDA GMP inspections or ISO quality audits.
- Increased Efficiency Through Automation: MasterControl software automates all tasks pertaining to the customer complaint process, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
- Simple Three-Step Process: This best-practice customer complaint 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: All documents related to customer complaint processes 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 management oversight and demonstrates appropriate controls to regulatory agencies. The customer complaint process 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 process may turn out to be the reporting of an adverse event, which comes with its own set of regulatory requirements. This 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.
- Solid Audit Trail: Provides a secure, time-stamped audit trail as required by 21 CFR Part 11 for the customer complaint process. 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 Complaint Process
Integrated Quality Management: MasterControl connects the paperless customer complaints process with other quality processes for a holistic approach to quality management.
- Easy Access: MasterControl customer complaints process is Web-based so it can connect employees, customers, suppliers, and others involved in the customer complaint process regardless of location.
- External Links: 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, this 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 processes with the corrective and preventive action process to automatically escalate any serious quality problem.
Complete Customer Complaint Process
Enterprise-wide Product Application: MasterControl can handle every department's forms and documents-based processes, making it an ideal enterprise-wide solution.
- Integrates with Other Applications: MasterControl's customer complaint process 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. Every department can maintain its own customer complaint process via 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 customer complaint 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 ones.
For More Information on Customer Complaint Processes
For more information about the customer complaint process, please feel free to contact a MasterControl representative.