Here are some of the robust features of our complaint management system that ensure your system is always Compliant, Connected, and Complete:
Compliant Complaint Management Software Systems
Sustained Compliance: Helps companies attain and sustain FDA, GMP, and ISO compliance by optimizing the complaint handling process, by speeding up the turnaround from complaint submission to resolution, and by keeping the overall quality system always ready for FDA GMP inspections.
- Increased Efficiency Through Automation: Automates all tasks pertaining to customer complaints - 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 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 complaints will be stored in a secure, centralized repository, making it easy to search and retrieve them during inspection or accreditation within the a complaint management system.
- Analytics and Reporting: MasterControl's advanced analytics and reporting capability increases management oversight and demonstrates appropriate controls to regulatory agencies. The complaint management system 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 management software system 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. Documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
- Revision Control: Ensures that only the current version of a document is available.
Connected Complaint Management Software
Integrated Quality Management: Connects the paperless customer complaints with other quality processes for a holistic approach to quality management.
- Easy Access: Web-based system connects employees, customers, suppliers, and others involved in the customer-complaint process regardless of location.
- External Links: 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 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: Provides the option to integrate customer-complaint handling with the corrective and preventive action process to automatically escalate any serious quality problem.
Complete Complaint Management Systems
Enterprise-wide Product Application: Handles every department's forms and documents-based processes, making it an ideal enterprise-wide solution.
- Integrates with Other Applications: Can be integrated with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
- Easy to Search: A standardized search bar is available throughout the complaint management system, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.
- Easy to Find: MasterControl's Explorer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Explorers and documents, which can be stored in multiple Explorers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard within the software.
- 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 ones int he complaint management software.
To learn more about complaint management software or complaint management systems, please feel free to contact a MasterControl representative.